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VR HSG
VR HSG
| https://doi.org/10.22541/au.166118224.46838782/v1 | This a preprint and has not been peer reviewed. Data may be preliminary.
Abstract
Objective: This study was conducted to determine the effect of virtual reality used during hysterosalpingography on perceived
pain, anxiety, fear, physiological parameters, and satisfaction in women. Design: A randomized controlled trial design was
used in the study. The CONSORT statement was used to report the findings. Setting: Ankara University Faculty of Medicine
Hospital. Methods: The study was conducted between April 26 and June 30, 2022. Patients were randomized into two groups
(the virtual reality=31, the control group=31). Main outcome measures: Anxiety was evaluated using the State Anxiety
Inventory; pain, fear, satisfaction were evaluated using the Visual Analogue Scale; the temperature, pulse, blood pressure,
and oxygen saturation were followed up. Results: The difference between the virtual reality group and the control group
in terms of their mean pain and fear scores during hysterosalpingography and 15 minutes after hysterosalpingography was
statistically significant. The difference between the mean anxiety scores of the groups was statistically insignificant. The
difference between the groups in terms of satisfaction with the hysterosalpingography procedure was statistically significant.
There was no statistically significant difference between the groups in terms of their physiological parameters just before,
immediately after, and 15 minutes after the hysterosalpingography procedure. Conclusions: In this study, it was determined
that the use of virtual reality during the hysterosalpingography procedure reduced pain and fear, increased satisfaction, but did
not affect anxiety and vital signs. In addition, women’s satisfaction with the use of virtual reality was high.
1. INTRODUCTION
Hysterosalpingography (HSG) is the first-line procedure for infertile patients in the examination of the uterus
and tubal factors1 . HSG is a very stressful procedure2 . It has been reported to cause significant pain, anxiety
and fear3 . For this reason, pharmacological and non-pharmacological interventions for reducing pain and
stress during the HSG procedure have been investigated in the literature4-9 .
Nurses, who are together with the patient at all stages of the procedure, are indispensable members of the
healthcare team, especially in the management of symptoms, such as pain, fear, and anxiety. It is important
that nurses, who are responsible for the administration of ordered pharmacological agents when necessary,
comfort patients before, during, and after a procedure with non-pharmacological methods that they can use
independently10-12 . Giving analgesics to patients before the HSG procedure leads to the expectation that no
pain will be felt, decreased patient cooperation during the procedure, and the use of additional analgesics
and anesthetics. Topical anesthetic agents, on the other hand, are well tolerated by patients and do not affect
cooperation during the procedure, but it is stated that topical anesthesia given to the cervical region only
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reduces pain during instrumentation and is ineffective in visceral pain due to uterus and tubal distension6 .
Posted on Authorea 22 Aug 2022 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.166118224.46838782/v1 — This a preprint and has not been peer reviewed. Data may be preliminary.
For this reason, the effectiveness of non-pharmacological methods should be evaluated as an alternative to
pharmacological methods to reduce the pain and anxiety experienced by women during the HSG procedure.
Virtual reality (VR), which is one of the methods that can be used to distract attention, is widely used
to relieve symptoms in clinical care by providing the opportunity to create therapeutic environments13-15 .
Some studies in the literature have shown that VR is used in painful procedures, such as orthopedic surgery,
burn dressing, lumbar puncture, endoscopy, breast biopsy, cystoscopy, chemotherapy and episiotomy16-21 .
VR, which is one of the non-pharmacological methods that can be used to control the individual’s pain,
anxiety, fear, and physiological parameters, is an intervention that nurses can apply independently. In this
context, it is thought that VR can be utilized to reduce pain, anxiety, and fear during the procedure and to
control the physiological parameters that may occur in women undergoing HSG. It is also considered that
these interventions will increase patients’ satisfaction with the HSG procedure.
This study was conducted to determine the effect of VR used during the HSG procedure on perceived pain,
anxiety, fear, physiological parameters, and satisfaction in women.
2. METHODS
2.1. Participants
The study was a randomized controlled trial with one control and one intervention group. Figure 1 presents
the consort diagram of the study phases. The universe of the study consisted of all women HSG in the
radiology department of a university hospital in Ankara between April 26 and June 30, 2022. A power
analysis was conducted using the G Power 3.1.0 software package to determine the sample size. For this
purpose, the results of the study conducted by Deo et al. were used as a reference. According to the power
analysis, the study sample was determined as a total of 58 (29 participants in each group) participants
(α=.05, 1-β =.95, Effect size d= 0.88, tail(s) = two). Since the dropout rate in the reference study was 5%,
it was planned to recruit a total of 62 women, including 31 in each group, in accordance with this rate. A
total of 94 women were evaluated for the study. Thirty-two of these women were not included in the study
since 26 of them did not meet the research criteria and 6 of them did not accept to participate in the study.
Therefore, the sample comprised 62 participants, including 31 in the virtual reality group and 31 in the
control group (Figure 1).
Inclusion criteria were as follows: Primary infertility, No hearing or vision problems, Not having undergone
an HSG procedure before
Criteria for Initial Elimination: Those with motion-sensitive diseases, receiving analgesics before the proce-
dure, use of antidepressants or sedatives and history of allergy to the radiopaque dye
Exclusion Criteria of the Study: Not watching the entire video and difficulty in the HSG process or completion
of the process with more than one attempt
The HSG procedure
HSG is performed two days a week in the radiology unit of the relevant hospital. The people who will take
an HSG test are determined by an obstetrician and a gynecologist beforehand and sent to the radiology
clinic. None of the patients received analgesics before the procedure. The procedure was performed while
the women were in a dorsal lithotomy position on the fluoroscopy table. 15-20 ml water-soluble contrast
media (Omnipaque 350; Nycomed Ltd., Birmingham, UK) was slowly injected, with fluoroscopic images
obtained intermittently to evaluate the uterus and fallopian tubes. The volume of radiopaque media used
during the procedure was recorded. After the HSG procedure was completed, the result of the procedure
was evaluated by the physician.
Application of the research
The study was carried out in two groups. The women who presented to the radiology clinic for an HSG were
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met and evaluated in terms of eligibility criteria for the study. The women who met the inclusion criteria
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were informed about the study and written informed consent was obtained from the women who accepted
to participate in the study. The random distribution of women into the study groups was carried out using
the simple randomization method. The following applications were conducted in the groups. This study was
conducted in accordance with the Consolidated Standards of Reporting Trials (CONSORT) 2010 guidelines.
The VR group
The women in the VR group of the study were shown a video via virtual reality glasses (VR SHINECON)
during the HSG procedure. The videos were created by the researchers by combining several videos. They
were prepared in three different themes: sea, undersea, and forest. The video selected by the patient was
started on the VR device after the patient was taken to the table for the HSG procedure and was stopped
when the procedure was completed. While the patient was watching the video, she also listened to the
relaxing music of the video at the same time.
The control group
Patients in the control group of the study did not undergo any treatment other than the HSG procedure.
Outcomes and Measurements
Anxiety
Anxiety was evaluated using the State Anxiety Inventory (SAI). The scale was developed by Spielberger 22
and the Turkish adaption was performed by Öner and Le Compte 23 . It consists of 20 items and is a 4-point
Likert-type scale. There are ten reversed statements. The total score that can be obtained from the inventory
varies between 20 and 80. The higher the score is, the higher the anxiety is. The reliability coefficient of the
SAI is between 0.94 and 0.96 23, 24 and in this study it was calculated as 0.89 in the first measurement and
0.94 in the second measurement. The SAI was applied to the control group and the VR group just before
and after the HSG test.
Pain
Pain was evaluated using the Visual Analogue Scale (VAS). This scale was developed by Price et al. 25 . It
is used to evaluate emotions and other subjective experiences 26 . The VAS is a 10 cm long measurement
scale. The left end of the scale reads ”no pain” and the right end ’worst pain imaginable’ 27 . The value
reported by the patients with the numbers marked on the scale was taken as the pain value. Baseline pain
was assessed just before starting the procedure in VR and control groups. Worst pain during HSG was
evaluated immediately after the HSG procedure. In addition, pain was re-evaluated 15 minutes after HSG.
Fear
Fear was evaluated using the Visual Analog Scale (VAS)-Fear. VAS is a 10-cm-long measurement tool. The
left end of the scale reads ”no fear at all” and the right end reads ”the most intense fear possible.” A high
score on the scale indicates a high level of fear, and a score of 0 shows no fear at all. Baseline fear about
the HSG procedure was assessed just before starting the procedure in VR and control groups. Immediately
after the HSG procedure, the most intense fear during HSG was evaluated. It was re-evaluated 15 minutes
after HSG.
Physiological Parameters Follow-up Form
The temperature, pulse, blood pressure, and oxygen saturation (SpO2) of the women in VR and control
groups were evaluated three times, including immediately before the procedure, immediately after HSG, and
15 minutes after HSG. Measurements were taken by the same researcher and by using the same instruments
to avoid measurement differences.
Satisfaction
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Satisfaction was evaluated using the Visual Analog Scale (VAS)-satisfaction. The VAS is a 10-cm-long measu-
Posted on Authorea 22 Aug 2022 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.166118224.46838782/v1 — This a preprint and has not been peer reviewed. Data may be preliminary.
rement tool. The left end of the scale reads ”I am not satisfied at all” and the right end reads ”very satisfied.”
A high score on the scale indicates a high level of satisfaction and a score of 0 shows no satisfaction at all.
The satisfaction of the women in VR and control groups with the HSG procedure was evaluated 15 minutes
after HSG using the VAS. In addition, the satisfaction of the women in the VR group with the use of VR
was evaluated with VAS-satisfaction 15 minutes after HSG. Also, the women in the VR group were asked
whether they would prefer the use of VR if they were going to have an HSG procedure again and whether
they would recommend it to other women who would undergo an HSG test.
Data analysis
SPSS Windows 24.0 software package was used for statistical analysis, and p<.05 was considered significant.
Normality was assessed by calculating skewness and kurtosis values and using the Shapiro–Wilk test. Fre-
quency, percentage calculations, chi-square test, independent samples t-test, and mann-Whitney U test were
used to analyze the data.
3. RESULTS
The descriptive characteristics of the participants are given in Table 1. No significant differences were found
between the two study groups for the descriptive characteristics (p>.05).
There was no statistically significant difference between VR and control groups in terms of median pain
score, and mean fear, anxiety, and satisfaction scores measured before HSG (p>.05). The difference between
the two groups was statistically significant for the most intense fear and worst pain scores during and 15
minutes after the HSG (p<.005). The mean anxiety scores evaluated immediately after HSG were similar in
the two groups (p=.843). When the satisfaction of the VR and control groups with the HSG procedure was
evaluated the difference was statistically significant (p=.023) (Table 2). Although not given in the table, the
mean score of women for satisfaction with the use of VR was 8.42+ 2.11, 87.1% of them stated they would
use VR if they were to take an HSG test again, and 96.8% of them recommended the use of VR during HSG
to other women who would take an HSG test.
Table 3 shows the comparison of fever, pulse, systolic blood pressure, diastolic blood pressure, and SpO2
values of the groups. These measurement values of the two groups are similar in all measurements (p>.05)
(Table 3).
4. DISCUSSION
4.1. Main Findings
As a result of our study, in which we evaluated the effect of virtual reality on the pain, fear, and anxiety
perceived by women during HSG, no statistically significant difference was found between VR and control
groups in terms of pain, fear, and anxiety scores measured before HSG. In this study, it was determined
that there was no difference between the groups in terms of physiological parameters. The satisfaction of the
VR group with the HSG procedure was significantly higher than that of the control group. Considering the
findings of the current study, it can be said that the use of VR during the HSG is an effective distraction
tool to alleviate pain and fear. VR is a simple and economical application that can be integrated into care.
4.2. Strengths and Weaknesses
This research is the first to examine the effect of VR use on HSG procedure. We can mention four strengths
of the research. The first is about the measures taken for validity and reliability. The women were sent to
the HSG procedure by obstetricians and gynecologists who were not included in the study, and selection
criteria were determined to prevent selection bias. Randomization was performed to avoid assignment bias.
In this context, women were assigned to the experimental and control groups by simple randomization. The
second is about the videos utilized in the study. Since the length of the videos was longer than the time of
the procedure, participants were able to watch the video during the procedure, and therefore the process
was not interrupted. In addition, three different video options were offered to the participants, and they
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were allowed to watch the video they preferred. This increased the adjustment of participants. None of the
Posted on Authorea 22 Aug 2022 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.166118224.46838782/v1 — This a preprint and has not been peer reviewed. Data may be preliminary.
participants in the VR group wanted to stop watching the video. Third, no side effects were observed in any
of the participants who used VR. Fourth is that the measurement tools used were easy to use and validated.
On the other hand, the research had three limitations. First, participants could not be blinded about the
intervention; therefore, we can mention a placebo effect. This may have influenced the results related to self-
reporting of outcome scores. That is, this might have led to under-reporting pain, anxiety, and fear scores by
patients who received the VR and over-reporting the scores by those who did not receive the intervention.
Second, the highest pain and fear experienced during HSG was assessed immediately after the procedure
was completed. This may have affected the outcome scores. Third, the results were based on self-reporting,
which did not include physiological parameters.
4.3. Interpretation of Findings
The mean VAS pain scores of the VR group during and 15 minutes after HSG were lower than those of
the control group. Studies showing that VR was effective in reducing pain in different areas28-31 . Deo et al.
found that women using VR during hysteroscopy experienced less pain32 . It was reported that the use of
VR in pediatric patients during IV administration21, 33 in burn treatment and dressing change34, 35 reduced
the level of pain. In fact, Clark defined VR as virtual pain relief36 .
Fernández-Sola et al. showed that HSG was a procedure that increased hope for success in infertile women
but was also found fearful by them37 . The mean VAS fear scores of the VR group were lower than those of
the control group during and 15 minutes after HSG. Özalp Gerçeker et al. found that VR use during blood
collection in children aged 5-12 years significantly reduced fear of the procedure28 . Chad et al. also found
that VR reduced fear in children before and after vaccination38 . In line with these results, it is seen that the
use of VR in medical procedures that may cause fear in patients is beneficial.
In this study, no difference was found between VR and control groups in terms of anxiety scores measured
after HSG. In studies conducted with different groups, it was found that VR was effective in reducing anxiety.
For example, in their study on the effect of VR use during dilatation curettage on anxiety, Sridhar et al.
stated that the anxiety levels of the VR group during and after the procedure decreased compared to those
of the control group39 . Reinders et al. reported that the informative VR that they applied to patients with
abnormal uterine bleeding in addition to the provision of traditional patient information yielded a significant
reduction in anxiety levels40 . In this study, it is thought that the reason why there was no difference in terms
of anxiety was that the anxiety experienced by women during HSG was not only related to the procedure
but also to the negative HSG result and the possibility that they would not be able to become pregnant.
In this study, it was determined that there was no difference between the groups in terms of physiological
parameters measured just before, immediately after, and 15 minutes after the HSG. Similar to our findings,
in their study evaluating the effects of VR use during operative hysteroscopy, Fouks et al. found that there
was no difference between the groups in terms of heart rate and respiratory rate during the procedure41 .
These findings may indicate that the use of VR does not affect physiological parameters.
In our study, it was determined that the mean satisfaction with the use of VR score of women was high,
approximately 9 out of 10 women would use VR again during HSG and that almost all of them would
recommend the use of VR during HSG to other women. Bekelis et al. found that VR used in the preoperative
period by patients scheduled for cranial and spinal surgery provided higher preoperative satisfaction42 .
Similarly, as a result of a randomized controlled study on the evaluation of the effect of VR on anxiety
experienced in case of abnormal uterine bleeding, Reinders et al. reported that 65% of women would use VR
again in the future40 . In line with these results, it can be said that patients are satisfied with VR use and
that the use of VR increases patients’ satisfaction with medical procedures.
5. CONCLUSION
In conclusion, it was determined in our study that the use of VR during HSG reduced pain and fear and
increased satisfaction with the procedure, but did not affect anxiety and vital signs. In addition, it was
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determined that women were highly satisfied with the use of VR during HSG and that almost all of them
Posted on Authorea 22 Aug 2022 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.166118224.46838782/v1 — This a preprint and has not been peer reviewed. Data may be preliminary.
would use VR if they were to take an HSG test again and recommended it to other women. In line with these
results, it is seen that the use of VR during HSG is beneficial. The results of this study, which show that VR
can be useful for distraction in painful procedures, will be combined with large-scale research in the future
and support the evidence. Once the necessary material and arrangements for VR are provided, it will be
available to all patients who accept the practice. In this respect, it is recommended that this easy-to-apply
and low-cost method should be used to relieve women during the HSG procedure and that the effectiveness
of the method should be investigated in terms of other painful gynecological interventions.
ACKNOWLEDGEMENT
We would like to express our gratitude to the staff of the radiology department of the relevant hospital and
the patients receiving service from this unit for their cooperation and contributions to the realization of the
current study.
CONFLICT OF INTEREST
There is no conflict of interest regarding this article.
FUNDING
No financial assistance was received from any institution or organization for the conduct of any stages of
this research.
CONTRIBUTION TO AUTHORSHIP
NYS: Project administration; Conceptualization; Data curation; Investigation; Methodology; Writing- review
& editing. MNA: Conceptualization; Data curation; Investigation; Methodology; Writing- review & editing.
İMG: Conceptualization; Formal analysis; Methodology; Writing- review & editing. ŞT: Conceptualization;
Methodology; Writing- review & editing. YEŞ: Conceptualization; Writing; Investigation; Supervision.
DATA AVAILABILITY STATEMENT
Due to the sensitive nature of the questions asked in this study, survey respondents were assured raw data
would remain confidential and would not be shared.
ETHICAL DIMENSIONS OF THE RESEARCH
At the outset, the ethical approval of the Ethical Committee of Ankara University (Date 28.02.2022 No:
04/49) and permission of the relevant institution were obtained. Written informed consent was obtained
from all participants included in the sample.
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Table 1. Distribution of participants’ descriptive characteristics (n=62)
Socio-
Demographic
and Obstetric VR Group Control Group
Characteristics (n=31) (n=31) Total Analysis Analysis
Mean+SD Mean+SD Mean+SD ta p
Age 30.41+6.41 31.52+5.58 30.97+27.40 -.719 .475
Duration of 4.55+3.99 4.71+4.06 4.63+3.98 -.158 .875
marriage
Duration of 2.19+2.64 2.61+2.35 2.40+2.49 -.661 .511
infertility
Body mass 27.36+6.78 27.44+4.81 27.40+5.83 -.053 .958
index (kg/m2)
n (%) n (%) n (%) χ2β p
Education
Status
Primary 8 (25.8) 7 (22.6) 15 (24.2) .097 .953
Education
High School 7 (22.6) 16 7 (22.6) 14 (22.6) 33
University and (51.6) 17(54.8) (53.2)
upper
Employment
Status
Yes 14 (45.2) 15 (48.4) 29 (46.8) .065 .799
No 17 (54.8) 16 (51.6) 33 (53.2)
Income Level
Low 7 (22.6) 5 (16.1) 12 (19.4) .429 .807
Middle 20 (64.5) 22 (71.0) 42 (67.7)
High 4 (12.9) 4 (12.9) 8 (12.9)
History of History of History of
gynecological gynecological gynecological
surgery surgery surgery
Yes 3 (9.7) 4 (12.9) 7 (11.3) 1.00c .500
No 28 (90.3) 27 (87.1) 55 (88.7)
The result of
HSG test
Both tubes 25 (80.6) 29 (93.5) 54 (87.1) - -
patent
Both tubes 3 (9.7) 1 (3.2) 4 (6.5)
occluded
One tube 3 (9.7) 1 (3.2) 4 (6.5)
occluded
Median Median Median Zd p
(Min-Max) (Min-Max) (Min-Max)
9
Socio-
Posted on Authorea 22 Aug 2022 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.166118224.46838782/v1 — This a preprint and has not been peer reviewed. Data may be preliminary.
Demographic
and Obstetric VR Group Control Group
Characteristics (n=31) (n=31) Total Analysis Analysis
The amount of 20.00 (10-40) 20.00 (10-40) 20.00 (10-40) .1.94 .052
radiopaque
media (cc)
10
VR Group Control Group
Posted on Authorea 22 Aug 2022 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.166118224.46838782/v1 — This a preprint and has not been peer reviewed. Data may be preliminary.
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Posted on Authorea 22 Aug 2022 — The copyright holder is the author/funder. All rights reserved. No reuse without permission. — https://doi.org/10.22541/au.166118224.46838782/v1 — This a preprint and has not been peer reviewed. Data may be preliminary.
12