Journal of Clinical Psychology

The impact of preoperative psychological counseling on

postoperative pain, analgesic consumption and
psychological symptoms on patients scheduled for breast
cancer surgery - a randomized clinical trial
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Journal: Journal of Clinical Psychology

Manuscript ID Draft
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Wiley - Manuscript type: Research Article

Keywords: breast cancer surgery, pain, analgesic, psychological symptom

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Breast cancer is the most prevalent malignancy for female patients and is
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5 increasing globally (1, 2). Despite the progress in the treatment of this disease and a
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7 relatively good prognosis (survival 80% at 5 years) of this disease at least 50% of the
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9 patients will develop symptoms of emotional and psychological stress from the moment
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of the diagnosis and during each stage of the disease (3,4,5). This distress comprises of
12 emotional and psychological problems (depression, anxiety, agitation, restlessness) and
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14 will depend on the various stages of the disease becoming more prevalent as the disease
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16 progresses (6). The surgery is an important stage in breast cancer treatment (1, 7). In pre-
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18 surgery settings the major causes of distress are: concerns about anesthesia, concerns
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19 about surgical procedure and its complications: pain, side effects, changes in appearance
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21 and scaring, concerns about prognosis, dying, the unknown, etc (8, 9, 10). Pre-surgery
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23 distress has been found to predict subsequent post-surgery side effects, including post-
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surgery acute pain, fatigue and nausea (11,12). More than this, apart of other types of
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disease, the female patients with the diagnosis of breast cancer have heightened level of
28 worry and distress associated with their disease (12). Because of this increased incidence
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30 and the huge emotional impact of these problems, pre-surgery psychological counseling
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32 can be proven very helpful for patients scheduled for breast cancer surgery (13). Pain is
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34 known to be the most common symptom after surgery (11, 14). Research shows 30-80%
35 of moderate or severe post surgery pain for patients having breast cancer surgery (15, 16).
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37 Considering the previous information and the fact that only 1 out of 4 patients are
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39 effectively treated regarding acute postoperative pain, it is obvious why one of the
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41 patients’ biggest concerns is managing the pain (17). Severe or untreated acute
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postoperative pain can be associated with a lot of complications: prolonged admission,
44 delay in discharge, re-admission, negative emotions, sleep deprivation, chronic pain
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46 which may require additional medications (11, 15, 17, 18). Despite their being a wide
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48 range of strong and effective pain relief medication these drugs can also have numerous
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50 side effects. In these settings Montgomery concluded that the development of non-
51 pharmacological intervention (as psychological counseling) can reduce the need for
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53 medication and provide symptom relief (as pain) for these patients could have a large
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55 impact (19, 21). However, the analgesics are effective for the physical component of
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57 pain. As was first cited by Cicely Saunders the pain is not purely a physical experience
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but has actually four components: physical, psychological/emotional, social and spiritual
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5 (20). This concept of “total pain” has been well accepted in the palliative care community
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7 (12, 14, 22).The contribution of each component will be specific to each individual and
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9 his or her case. Accepting this point of view, for the adequate management of pain it is
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necessary to take into account all these components of the pain experience. Based on
12 these concepts, the aim of our study was to determine whether influencing the
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14 psychological component of pain by preoperative psychological counseling using
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16 relaxation techniques has any effect on postoperative acute pain and /or postoperative
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18 analgesic consumption for the patients scheduled for radical modified mastectomy
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19 (MRM) for breast cancer. Another aim of our study was to determine, whether there is
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21 any effect of preoperative psychological counseling on the incidence and severity of
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23 postoperative psycho-emotional symptoms (anxiety, restlessness, agitation). We planned
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to test the hypothesis that preoperative psychological counseling (relaxing techniques)
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would decrease post-surgical pain and analgesics consumption. The results of our study
28 will increase our understanding about the effective methods in treating postoperative
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30 acute pain and in doing so we will propose and develop further intervention to decrease
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32 postoperative pain.
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35 Material and methods
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This study was a prospective, randomized, single centre, clinical trial.
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38 Ethical approval for this study was provided by the ethical committee of Oncology
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40 Institute “Prof. Dr. I. Chiricuta” Cluj-Napoca (IOCN), Romania. All the participants
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42 included in our study were female patients scheduled for breast cancer surgery in IOCN.
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44 Written informed consent was obtained from all patients who participated in this study.
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We enrolled all the patients undergoing elective MRM for breast cancer, under general
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47 anesthesia, between January – July 2015. All were American Society of Anesthesiologist
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49 (ASA) physical status class 1, 2 or 3. Exclusion criteria included: uncontrolled, major
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51 mental disorders (depression), allergies (NSAIDs, opioids, paracetamol), metastatic
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disease, previous breast surgery and bilateral surgery. Eligibility was confirmed before
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The preoperative data (demographic and clinical data) were collected from the
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5 medical records: age, demographic area, height, weight, body mass index (BMI),
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7 pathology, chronic treatment, neoadjuvant chemotherapy, tumor grade. The
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9 anesthesiologists and the researcher gave instructions to the patients regarding using a
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numerical rating scale (NRS) for assessment of postoperative acute pain (with 0= no
12 pain; to 10, the worst imaginable pain) (31). Also, all the patients were instructed for
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14 using NRS for anxiety, agitation, restlessness (with 0= no symptom; to 10= the worst
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16 imaginable symptom). After this, the patients were randomized by the researcher in one
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18 of two study groups: Group 1 – psychological counseling and Group 2- control group.
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19 The randomization was made by free hazard and we have to note that this randomization
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21 allocation resulted in unequal numbers of patients in the groups (Figure1). 6 patients
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23 randomized to Group 1 refused the psychological counseling after consenting to the trial
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and they were allocated to control group 2. This was one of the limitations of our study
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because we did not want to force the patients for any reason. 52 patients included in
28 Group 1 received 30 minutes psychological counseling in the morning of the surgery. The
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30 psychological counseling was performed by the same clinical psychologist using the
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32 same relaxing techniques. This intervention took place in a private room away from
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34 clinical staff. The protocol for the relaxing techniques was established by the
35 psychologist. The session included: a short clinical semi-structured interview, a
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37 progressive relaxing technique combined visual imagery and suggestions to experience

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39 relaxation and peace. The psychologist collected no outcome data. These data were
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41 collected by the researcher and by the nurses.The protocols for surgery and anesthesia
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followed uniform institutional practice. Before anesthesia, the patients did not receive
44 premedication and received an infusion of crystalloid after monitoring including ECG,
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46 noninvasive blood pressure and pulseoximetry. Induction was made with midazolam,
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48 fentanyl , propofol and atracurium for facilitation the traheal intubation. Anesthesia was
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50 maintained with Sevoflurane in O2/air. Fentanyl and atracurium were then administered
51 according to the patient’s needs. During the surgery, all the patients received 100 mg
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53 intravenously ketoprofen. Postoperative analgesia included opioid- tramadol 100 mg
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55 intravenously as requested or when NRS>6, ketoprofen 100 mg intravenously at the
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57 patients’s requested or when NRS>2, maximum 3 doses daily and paracetamol 1 g
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intravenously as requested or when NRS>3, maximum 4 doses daily. The surgery was
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5 performed by the different surgeons from IOCN using the same surgery protocol.
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7 The intraoperative variables, the surgery time (time from the skin incision until
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9 anesthesia was discontinued) and total opioid consumption were recorded from the
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medical papers of Anesthesia Department in the day of surgery. Postoperative variables
12 were assessed immediately after arrival in the recovery room (T1), at 2 (T2), 8 (T3), 12
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14 (T4) and 24 hours (T5) in the day of surgery and every 6 hours (T6, T7, T8, T9) in the
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16 first day after surgery. Postoperative pain intensity and the presence and intensity of
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18 psychological symptoms were assessed using NRS as we described before by the study
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19 researchers and by the nurses who were all instructed about the protocol of our study and
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21 about how to use NRS. If the patient was sleeping at the proposed time of evaluation, the
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23 score was 0/sleep. The patients who had psychological symptoms more severe than
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NRS=5 were scheduled for psychological counseling.
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28 Statistical analysis
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30 Categorical data was presented by counts and percentages. Continuous variables were
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32 presented by medians and interquartile ranges (IQR). The differences between groups in
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34 respect of categorical data were tested with Chi square test or Fisher exact test. The
35 differences between continuous variables were tested with Mann Whitney U test when
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37 skew data was found. Normality of the data was assessed with Shapiro Wilk test, and
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39 quantile plots. For the prediction of VAS and the intra surgery and post surgery opioid
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41 consumption multiple linear regression models were used. For each of these dependent
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variables a full model was built with the following explanatory variables age, BMI,
44 residence place, associated pathology, chronic treatment, anesthesia ASA risk class,
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46 neoadjuvant chemotherapy, length of the surgery, intraoperative opioid use,
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48 psychological counseling. In case of post surgery dependent variables at 24 and 48 hours,
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50 the consumption of analgesic drugs was also entered in the full models: opioids, NSAID,
51 paracetamol. Starting with the full model a best subset procedure for selecting the
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53 variables for the final model, was used, using the Beyesian information criterion. The
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55 normality of residuals, heteroschedasticity, multicolinearity were evaluated. If
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57 heteroskedasticity was present, robust confidence intervals were computed using the
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sandwitch package. For all statistical tests, a two sided p-value was used, and the level of
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5 significance chosen was 0.05. All statistical analysis was carried out with the R
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7 environment for statistical computing and graphics, version 3.2.0 (23).
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11 Results
12 Of the 108 enrolled patients, 102 completed the study. Four patients were
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14 excluded because NSAIDs allergy and two because the surgery was postponed for the
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16 next day (Figure 1). We present the data from the remaining 102 patients who completed
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18 the study. Demographic (age, rural/urban, weight, height, IMC) and clinical (neoadjuvant
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19 chemotherapy, chronic medication, ASA) data were similar in both groups excepting
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21 place of living (Table nr 1). Group 1 had moderate postoperative bleeding as
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23 complication.
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In the psychological counseling group the values for pain intensity were
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statistically significant lower compared to control group values. The univariate and the
28 multivariate analysis for the final model (p<0.001, adjusted determinant coefficient=0.46)
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30 for factors that influence pain intensity immediately after awakening are shown in (Table
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32 nr 2).The patients living in rural areas have a higher tolerance to pain compared to those
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34 living in urban areas. Also, the patients with previous pathology have a lower tolerance to
35 pain compared to those without other pathology.
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38 Two hours (T2), 8 (T3) , 12 (T4), 24 (T5) hours after surgery, in Group 1 pain
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intensity was statistically significant lower compared to Group 2 (Table 3). The
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41 univariate and the multivariate analysis for the final model (p=0.005, adjusted
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43 determinant coefficient=0.09) for factors that were associated with the pain intensity 24
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45 hours post surgery are shown in Table 4.
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47 Our results show that the quantity of opioid used during the surgery and BMI are
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49 related to the intensity of postoperative acute pain at 24 hours after surgery. A greater
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51 amount of opioid used during the surgery was associated with a lower intensity of pain. A
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higher BMI was associated with higher intensity of pain (Table 4).
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We obtained similar data at 6 (T6) and respectively 12 hours (T7) in the second
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5 day of surgery. The scores of pain were lower in group 1 compare with group 2. Again,
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7 this difference is statistically significant (Table nr 3).
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9 48 hours after surgery, the intensity of pain was similar in both groups (Table 3).
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In Group 1, maximum of pain intensity was 4 out of 10 NRS. In Group 2,
12 maximum of pain intensity was 8 out of 10 NRS (Table nr 3).
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14 The difference between mean scores in the two groups is about 5 points out of 10
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16 NRS in the recovery room (1.5 in Group 1 versus 6 in Group 2). Also, the difference
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18 between mean scores in the two groups is about 3 points on NRS (1-10) at 2 hours post
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19 surgery (1 in Group 1 versus 4 in Group 2).
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21 The amount of intravenous opioid (expressed in number of ampoule of 100 mg
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23 tramadol) was statistically significant lower in Group psychological counseling compared
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to control group both in the first and the second day after surgery (Table 5). The amount
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of NSAIDs (expressed in number of ampoule of 100 mg ketoprofen) was statistically
28 significant lower in Group psychological counseling compared to control group both in
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30 the first and the second day after surgery (Table 5). The amount of intravenous
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32 paracetamol (expressed in number of bottles of 1g paracetamol) was similar in the two
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34 groups (Table 5).
35 Psychological postoperative symptoms were more frequent in Control group
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37 compared with Group 1 during the complete evaluation period. The differences are
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39 statistically significant at 6, 12, 24, 30 and 48 hours after surgery (Table 5). There was no
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41 statistically significant difference at 36 hours after the surgery. In 48 hours period,
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comparing the intensity of psychological symptom we founded that in Group 1 the
44 intensity and the incidence of these symptoms were lower compared to Group 2. These
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46 symptoms were mild (anxiety, restlessness) and only 2 patients from Group 1 and
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48 respectively 3 patients from Group 2 needed further psychological counseling.
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51 Discussion
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53 Our study aimed to investigate the impact of preoperative psychological
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55 counseling for the female patients undergoing breast cancer surgery. The present
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57 randomized controlled trial demonstrated that psychological counseling before breast
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cancer surgery significantly reduced both the patient-reported intensity of acute post
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5 surgical pain and the need of postoperative analgesics, especially opioids and NSAIDs.
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7 The relaxing technique intervention also reduced post surgery psychological symptoms as
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9 was shown in the literature (19, 21). The intensity of acute post surgery pain was reduced
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to an extent that was within the range recommended in the medical papers, and
12 corresponding with effect sizes in surgical hypnosis literature (19, 24).
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14 It is well known that the intensity of pain is greater in the first hours and days
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16 after surgery and then decreases until it disappears, along with the healing process (25).
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18 So our study showed that the psychological intervention was most effective when the
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19 pain was more severe. More than this, the previous studies showed that pain intensity
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21 with a score of more than 4 out of 10 has negative effects on the mood, general activity,
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23 postoperative mobility and because of this is very important to treat it (26). As we
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showed before, patients from Group 1 had a maximum of 4 out of 10 for pain intensity.
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This means that these patients receiving psychological support did not have severe pain
28 after surgery. In our opinion this is a very important outcome and finding of our study.
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30 The impact of relaxation techniques on analgesics consumption in post surgical
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32 settings should be considered in the context of current medical practice. The
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34 recommendation is to find non-pharmacological options for pain treatment because every
35 drug has side effects which are often unpleasant and severe (nausea, dizziness,
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37 constipation, gastritis, respiratory failure, etc). Any decrease in the analgesics use can be
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39 associated with less side effects and a subsequent better mood of the patients. It is
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41 obviously that in setting of lower pain intensity the need of analgesic is also lower but the
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decrease of opioids and NSAIDs used showed in our study is further proof of the strength
44 of the results regarding the effect of psychological intervention on acute post surgical
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46 patient-related pain.
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48 The effectiveness of psychological counseling applied before breast cancer
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50 surgery showed by us is in accordance with other finding in the literature (9,19,21). We
51 investigated these effects for the next 48 hours after surgery but this period free of
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53 psychological symptoms can be longer. Anyway we did not identify moderate or severe
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55 symptoms and the incidence of the psychological symptoms was lower. There are just a
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57 small number of studies that evaluated the effectiveness of the pre operative
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psychological intervention in cancer surgery patients. These interventions have been
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5 typically administered after cancer surgical treatment, when the symptoms appear. As
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7 Lehto pointed out, our opinion is that the period immediately before the surgery is
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9 particularly distressing for cancer patients. A more effective intervention could be
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achieved if is delivered before surgery. It is better to prevent than to treat a symptom so
12 these are our reasons for choosing to opt for the psychological intervention before the
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14 surgery (26, 27). The trials evaluating the influence of pre surgery psychological
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counseling showed contradiction in the results obtained. But both, the type of
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18 psychological intervention (relaxation technique, brief cognitive behavioral intervention,
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20 stress management training, hypnosis, individual counseling, and supportive group) and
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22 the type of surgery (cardiovascular, abdominal, breast, etc) were variables. Even hypnosis
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was proven to have positive effects on pain and other symptoms in post breast and
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25 cardiac surgery , there are very limited randomized clinical trials which can confirm this
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27 and clinical guidelines at present lack clear recommendations and protocols. Other
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31 Montgomery et al. have demonstrated the effectiveness of brief hypnosis intervention to
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control side effects in breast surgery patients. This intervention was associated with a
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34 reduced intraoperative analgesic and sedative, patient-reported postsurgical pain
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36 intensity, nausea, fatigue, discomfort and emotional upset (19, 21). Also, some evidence
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38 supports the role of preoperative psychological interventions (preoperative ‘‘mind–body
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and psycho-educational’’ or brief cognitive behavioral intervention ) for patients
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41 undergoing coronary bypass graft surgery. It was shown that this intervention
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43 significantly reduced the length of hospital stay, anxiety, and depressive scores (28, 29).
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45 On the contrary, Burton et al. could not identify any changes in temperature, pulse, blood
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47 pressure, or pain after mastectomy in patients receiving a psychotherapeutic intervention
48 provided by a clinical psychologist or a trained surgeon (30). Also, Garssen et al.
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50 evaluated the psychological effects of presurgical stress management training (SMT) in
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52 breast cancer patients using four sessions in total. Their results of the study showed that
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54 short psychological intervention is effective in reducing depression and fatigue in the
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postsurgical period, although the effects are of short duration. They did not find any
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effect of the psychological intervention on pain intensity (31). Anyway, the authors
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5 evaluated a different psychological intervention.
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7 For the moment, the role of preoperative psychological interventions and what
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9 type of psychological intervention is the best in different settings for patients undergoing
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breast cancer surgery is unclear. The present relaxing technique intervention appears to
12 be one of the rare clinical interventions that can reduce both physical and emotional
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14 symptoms and the analgesics consumption. Of course, the reduced use of medication
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16 could lead to a reduction in costs but we did not analyze this aspect.
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18 Our study is not without limitations. One limitation is that patients were not blind
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19 assigned to group .Unfortunately, the design of our study made the blind randomization
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21 practically impossible. This was not possible because the patients who received pre
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23 surgery psychological counseling were informed about the intervention, the time scale of
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intervention and they had to be actively involved in the procedure. It is obvious that this
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explanation should not be offered to the patients from the control group. The absence of
28 blind randomization of the patients could lead to errors or mistakes in data collection and
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30 postsurgery evaluation but we avoided this by the fact that the psychologist was not
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32 involved in the collection of the data. There is also a risk that differences may arise in the
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34 patient’s characteristics and this could influence the results. An example of this error
35 could be the amount of opioid given during the surgery but we did not identify any
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37 differences between the two study groups. Another limitation of our study is the small
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39 number of the patients included. However we demonstrated results strong enough to
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41 make this study appropriate to continue with an increased number of patients.
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This study was possible because a clinical psychologist is employed by the
44 hospital but in Romania the majority of the hospitals do not have this type of specialist
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46 which limits patient access to these services. In these conditions it is necessary to identify
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48 any other clinical methods for improving perioperative distress and symptoms. Our study
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50 in the first on in this field of interest conducted in our country where the clinical
51 psychology is still a young specialization.
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53 The results of the study suggest further research directions. First, it will be of
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55 interest to investigate the benefit of continuing psychological intervention after surgery.
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57 Second, it will be important to evaluate the positive effective found in our study over a
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longer period of time (e.g. pain intensity until discharge or at one month after surgery).
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5 Third, it will be necessary to evaluate and to compare the total cost in both groups.
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7 Fourth, future study should confirm our results and should be extended to other type of
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9 patients and different types of cancer requiring surgery.
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12 Conclusions
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14 Our study demonstrated strong evidence of the positive effects of psychological
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16 intervention on several outcomes: acute postoperative pain intensity, postoperative
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18 analgesics consumption and incidence and severity of psychological symptoms for
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19 female patients scheduled for breast cancer surgery. Our findings indicate that these
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21 patients are in a complex and difficult situation and they need our help. These results are
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23 supportive for further studies in this field. The confirmation of positive impact of
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psychological intervention supports future the implementation of this intervention in the
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standard of care for these patients.
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30 Conflict of interest
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32 None declared.
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35 Acknowledgement
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39 Development Operational Programme 2007-2013, project no. POSDRU/159/1.5/138776.
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41 Grant with title: “Model colaborativ institutional pentru translatarea cercetarii stiintifice
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biomedicale in practica clinica – TRANSCENT”
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46 References
47
48 1. WHO, 2013
49 2. http://eco.iarc.fr/eucan
50
51
3. Kornblith, A. B., & Ligibel, J (2003) Psychosocial and sexual functioning of
52 survivors of breast cancer. Semin.Oncology 30(6):799-813
53 4. Tatrow, K., & Montgomery, G.H (2006) Cognitive behavioral therapy techniques
54
55 for distress and pain in breast cancer patients: A meta-analysis. Journal of
56 Behavioral Medicine 29(1):17–27
57
58
59
60
10
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5. Holland , J. C. and Alici Y (2010) Management of distress in cancer patients.
4
5 Review. The Journal of supportive Oncology 8(1):1-10
6 6. Aebi S, Davidson T, Gruber G, Cardoso F (2011) Primary breast cancer. ESMO
7
8
Clinical Practice Guidelines foe diagnosis , treatment and follow-up. Ann Oncol.
9 22(Suppl 6):12-24
10 7. Association of Breast Surgery at Baso (2009) Surgical guidelines for the
11
12 management of breast cancer. Eur J Surg Oncol 35(Suppl 1):1-22
13 8. Klafta JM, Roizen MR (1996) Current understanding of patient’s atitudes toward
14 and preparation for anaesthesia: a review. Anest Analg 83(6):1314-1321
15
16 9. Schnur JB, Hallquist MN, Bovbjerg DH, Silverstein JH, Stoiceska A,
17 Montgomery GH (2007) Predictors of expectancies for post-surgical pain and
18 fatigue in breast cancer surgical patients. Personality and Individual Differences.
Fo
19
20 42:419–42
21 10. Zaza C, Baine N (2002) Cancer pain and psychosocial factors: a critical review of
22
the literature. J Pain Symptom Manage 24:526–42.
r
23
24 11. Katz J, Pleshuck E, Andrus C et al (2005) Risk factors for acute pain and its
Pe

25 persistence following breast cancer surgery. Pain 119:16-25

26
27 12. Montgomery GH, David D, Goldfarb AB, Silverstein JH, Weltz CR, Birk JS,
28 Bovbjerg DH (2003) Source of anticipatory distress among breast surgery
er

29 patients. Journal of Behavioral Medicine 26(2)153-163

30
31 13. Johnston M, Vogele C (1993) Benefit of psychological preparation for surgery: a
32 meta-analysis. Ann Behav Med 15:245–56
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33 14. Melvin G Gitlin. The perioperative patient in pain:apllication of opioid sparing

34
35 and multimodal therapy . www.medscape.org
36 15. Hickey OT, Burke SM, Hafeez P, Mudrakouski AL, Hayes Idet Shirten GD
vi

37
(2010) Severity of acute pain after breast surgery is associated with likelihood of
38
39 subsequently developing persistent pain. The Clinical Journal of Pain 26: 556-560
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40 16. Polomano RC, Dunwoody CJ, Krenzischek DA, Rathmell JP (2008) Perspective
41
42
on pain management in the 21st century. Journal of Perianesthesia Nursing 23(1
43 Suppl):4-14
44 17. Cleeland C. (1984) The impact of pain on the patient with cancer. Cancer
45
46 58:2635-41.
47 18. Pavlin DJ, Chen C, Penaloza DA, Polissar NL, Buckley FP (2002) Pain as a factor
48 complication recovery and discharge after ambulatory surgery. Anesth Analg.
49
50 95(3):627–634
51 19. Montgomery GH, Bovbjerg D, et al (2007) A randomized clinical trial of a brief
52
hypnosis intervention to control side effects in breast surgery patients. Journal of
53
54 National Cancer Institute. 99:1304-1312.
55 20. Saunders CM. The management of terminal malignant disease, 1st ed. London:
56
57
Edward Arnold; 1978
58
59
60
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John Wiley & Sons
 Journal of Clinical Psychology Page 12 of 15

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21. Montomery GH, Hallquist M N, Schnur J B, David D, Silverstein J H, Bovbjerg
4
5 D H (2010) Mediators of a brief hypnosis intervention to control side effects in
6 breast surgery patients: response expectancies and emotional distress, J Consult
7
8
Clin Psychology 78(1):90-88
9 22. Syrjalak K, Chapka M (1995) Evidence of biopsychosocial model of cancer-
10 related pain. Pain 61:69-79
11
12 23. R Core Team. R: A Language and Environment for Statistical Computing
13 [Internet]. Vienna, Austria; 2015. Available from: http://www.r-project.org
14 24. Revicki DA, David C, Hays RD, Sloan JA, Lenderking WR, Aaronson NK (2006)
15
16 Responsiveness and minimal important differences for patient reported outcomes
17 Health Qual Life Outcomes Ann Behav Med. 31(2):165-72.
18 25. Wilder-Smith OH. Changes in Sensory Processing After Surgical Nociception.
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20 Curr Rev Pain 2000; 4(3): 234-41.
21 26. Peters ML, Sommer M, van Kleef M, Marcus MA (2010) Predictors of physical
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and emotional recovery 6 and 12 months after surgery. Br J Surg 97(10):1518-
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25 27. Lehto RH, Cimprich B. (1999) Anxiety and directed attention in women awaiting
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27 breast cancer surgery. Oncol Nurs Forum 26: 767–72
28 28. Arthur HM, Daniels C, McKelvie R, Hirsh J, Rush B (2000) Effect of a
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29 preoperative intervention on preoperative and postoperative outcomes in low-risk

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31 patients awaiting elective coronary artery bypass graft surgery: a randomized,
32 controlled trial. Ann Intern Med 133:253–62
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33 29. Dao TK, Youssef NA, Armsworth M, Wear E, Papathopoulos KN, Gopaldas R
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35 (2011) Randomized controlled trial of brief cognitive behavioral intervention for
36 depression and anxiety symptoms preoperatively in patients undergoing coronary
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artery bypass graft surgery. J Thorac Cardiovasc Surg 142:e109–15
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39 30. Burton MV, Parker RW, Farrell A, et al (1995) A randomized controlled trial of
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40 preoperative psychological preparation for mastectomy. Psycho-Oncology. 4:1–

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43 31. Garssen B, Boomsma MF, Meezenbroek Ede J, et al (2013) Stress management
44 training for breast cancer surgery patients. Psychooncology 22:572–80
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46 32. Hjermstad MJ, Fayers PM, Haugen , Caraceni A, Geoffrey W. Hanks GW,Loge
47 JH, Fainsinger R, Nina Aass N, Kaasa S (2010) Studies Comparing Numerical
48 Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for Assessment
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50 of Pain Intensity in Adults: A Systematic Literature Review. J of Pain and
51 Symptoms Management 41(6):1073–1093
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Table 1 Demographic and clinical characteristics
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5
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7 Psychological Control group P
8 counseling (n=50)
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10
(n=52)
11 Age (years), mean (SD) 52.25 (12.23) 59.04 (10.75) 0.221
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13 BMI (kg/m2), median (IQR) 27.61 (24.72 - 30.2) 28.46 (24.39 - 31.87) 0.455
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Rural place of living nr (%) 22 (42.31) 12 (24) 0,05
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18 Pathology (%) 33 (63,46) 36 (72) 0,357
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20 Chronic treatment nr (%) 25 (48,08) 32 (64) 0,105
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22 Neoadjuvant chemotherapy nr 28 (53,84) 27 (54) 0,998
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(%)
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Anaesthesiological risk (ASA), 29 (19 – 39) 29 (19 – 39) 0.808
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25
26 median (IQR)
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28 Surgery time (min), median (IQR) 50 (40 - 60) 52.5 (45 - 60) 0.211
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31 Opioids consumption (mg), 0,15 (0,15-0,15) 0,15 (0,15-0,15) 0,61
32 median (IQR)
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34 Postsurgery complications nr (%) 4 (7,69) 0 (0) 0,118
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The absence of postoperative 47 (90,38) 27 (55,1) <0,00
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38 psychological symptoms nr (%) 1
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Table 2 Factors that influence the pain intensity immediately after awakening
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48 B (95% CI) p B (95% CI) p
49 univariat adjusted
50 Rural area living -0.57 (-1.81 -0.66) 0.358 -1.33 (-2.25 - - 0.005
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52
nr 0.41)
53 Previous 1.21 (-0.01 -2.43) 0.053 0.98 (0.06 - 1.89) 0.037
54 pathology nr
55 Psychological -3.61 (-4.53 - - <0.001 -3.89 (-4.76 - - <0.001
56 counseling nr 2.69) 3.01)
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5 Table 3 Intensity of acute postsurgery pain using NRS
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7 After surgery time (hours) Psychological Control P
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(n=52) (n=50)
11 0 1.5 (0 - 4) 6 (5 - 8) < 0.001
12 2 1 (0 - 4) 4 (2 - 5) < 0.001
13 8 1 (0 - 3) 2 (1 - 4) 0.025
14 12 0 (0 - 0.25) 1 (0 - 2) 0.002
15 24 0 (0 - 1) 1 (0 - 2) 0.002
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17 30 0 (0 - 0) 2 (0 - 3) < 0.001
18 36 0 (0 - 0) 0 (0 - 2) 0.039
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19 48 0 (0 - 0) 0 (0 - 0) 0.737
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24 Table 4 Factors that influence the pain intensity 24 hours after surgery
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27 B (95% CI) p B (95% CI) p
28 univariate adjusted
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29 IMC (kg/m2) 0.07 (0.01 - 0.13) 0.028 0.08 (0.08 - 0.14) 0.029
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31 Intraoperative -6.12 (-16.52 - 4.28) 0.246 -8.74 (-15.92 - - 0.019
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opioids (mg) 1.55)
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35 Psychological -0.75 (-1.37 - -0.13) 0.019 -0.71 (-1.31 - -0.1) 0.024
36 counseling nr
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Page 15 of 15 Journal of Clinical Psychology

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5 Table 5 Postoperative analgesics
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7 Analgesic (nr.), median (IQR) Psychological Control group P
8 counseling (n=50)
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10
(n=52)
11 Opioids day 1) 1 (0 - 1) 2 (2 - 2) < 0.001
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13 NSAIDs day 1 1 (1 - 1) 1 (1 - 2) < 0.001
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15 Paracetamol day 1 0 (0 - 0) 0 (0 - 1) 0.019
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18 Opioids day 2 0 (0 - 0) 1 (0 - 1) < 0.001
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20 NSAIDs day 2 0 (0 - 1) 1 (1 - 1) < 0.001
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Paracetamol day 2 0 (0 - 0) 0 (0 - 0) 0.268
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Opioids day 1+2 1 (0 - 1) 3 (2 - 3) < 0.001
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27 NSAIDs day 1+2 1 (1 - 2) 2 (2 - 3) < 0.001
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29 Paracetamol day 1+2 0 (0 - 0) 0 (0 - 1) 0.173

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33 Table 6 NRS for psychological symptoms for 48h

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Postsurgery time (hours) Psychological Control group- P
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counseling- NRS
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38 NRS (n=50)
39 (n=52) median (IQR)
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40 median
41 (IQR)
42
43
recovery room 0 (0 - 0) 0 (0 - 0) 0.039
44 6 0 (0 - 0) 0 (0 - 2.75) < 0.001
45 12 0 (0 - 0) 0 (0 - 0) 0.011
46 24 0 (0 - 0) 0 (0 - 0) 0.021
47 30 0 (0 - 0) 0 (0 - 0) 0.006
48
42 0 (0 - 0) 0 (0 - 0) 0.537
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50 48 0 (0 - 0) 0 (0 - 0) 0.021
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