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ORIGINAL ARTICLES

Perioperative Music or Headsets to Decrease


Anxiety
Brenda Johnson, BSN, RN, CPAN, Shirley Raymond, BSN, RN, CPAN, Judith Goss, BSN, RN
The ambient noise of monitors, other patients, and staff in the postanesthesia care unit/operating room may elevate levels of anxiety. The
purpose of our study was to determine the effect of music versus noiseblocking headphones on the level of anxiety in women undergoing gynecologic same-day surgery. Institutional Review Board approval was
obtained. The women were approached for consent and randomized to
usual care, music with headphones, or headphones only. Preoperative
and postoperative anxiety was rated on a scale of 0 to 10. Music/headphones were continued throughout surgery and removed when Aldrete
level of consciousness equaled 2. The 119 women had a mean age of
38.8 (standard deviation 5 2.2) years. Of interest, 51 (45%) reported
very low preoperative anxiety (0-3/10) and were excluded. All groups experienced a drop in anxiety from pre- to postoperative status, but the
usual care group had the least improvement (P , .05). The music group
experienced the lowest postoperative anxiety scores; the headphone
group had a greater change overall. Music is a relatively inexpensive intervention, easy to administer, and noninvasive.
Keywords: music therapy, anxiety, perioperative care, research, music,
perianesthesia.
2012 by American Society of PeriAnesthesia Nurses

PREOPERATIVE PATIENTS FREQUENTLY experience anxiety. Surgery itself is stressful. Patients


may worry about the outcomes of surgery or the
possibility of complications. In a prospective study
of patients scheduled for outpatient surgery, it was
found that 57% did not feel calm. This number increased to 65% when only women were studied.1
Furthermore, the ambient noise of monitors, other
patients, and staff in the same-day surgery (SDS),

Brenda Johnson, BSN, RN, CPAN, is a Staff Nurse, PACU;


Shirley Raymond, BSN, RN, CPAN, is a Staff Nurse, PACU;
and Judith Goss, BSN, RN, is a Staff Nurse, PACU, The Christ
Hospital, Cincinnati, OH.
Conflict of interest: None to report.
Address correspondence to Brenda Johnson, PACU, The
Christ Hospital, 2139 Auburn Avenue, Cincinnati, OH 45219;
e-mail address: Brenda.Johnson@thechristhospital.com.
2012 by American Society of PeriAnesthesia Nurses
1089-9472/$36.00
doi:10.1016/j.jopan.2012.03.001

146

operating room (OR), and postanesthesia care


unit (PACU) may elevate levels of anxiety.2
A review of the literature indicated support for music therapy in reduction of preoperative stress and
anxiety. However, randomized control studies
could not be found that incorporated the use of
music during the entire perioperative period.
Also, studies conducted did not differentiate between whether anxiety reduction was because of
music or blocking environmental noise.

Literature Review
Music therapy is the process of bringing about
changes from undesirable, unhealthy, and uncomfortable conditions to more pleasant ones by the
deliberate use of music.3 Music has played an important role in health care and healing since the
beginning of recorded history. Mothers have
sung lullabies to soothe their children. Florence

Journal of PeriAnesthesia Nursing, Vol 27, No 3 (June), 2012: pp 146-154

PERIOPERATIVE MUSIC

Nightingale stated, Unnecessary noise is that


which hurts a patient in her Notes on Nursing
in 1859.2 She goes on to write about the noise of
a whispered conversation creating more harm
than a louder noise. The strain of the sick patient
listening to a conversation that may be concerning
them was considered the worst of offenses. Today,
we need to remember that as more advanced technology is being used, noise levels also increase.
Music and noise-blocking headphones can be helpful tools. Studies have been conducted to validate
the use of music as a therapeutic tool (Table 1).
Three studies in the literature examined the effects
of music on anxiety and pain.4-6 Heiser et al4 studied
a group of patients undergoing a microdiscectomy.
Patients were randomly assigned to music or no music, intraoperatively and postoperatively. Pain and
anxiety were measured using a visual analog scale
(VAS). The sample group of 10 used in the study
by Heiser et al was not large enough for statistical
difference. However, all in the music group commented very positively, stating how relaxing the
music was and they would like to listen again.

147

control group in anxiety and pain (P 5 .002 and


P 5 .026, respectively).
Several studies examined only anxiety. Andrada
et al8 studied the anxiolytic effect of listening to
music during colonoscopies. The STAI was given
30 minutes before the procedure and 30 minutes
after. There was a significant decrease in scores
in the experimental group with P , .01.
In the study of a group of 30 men undergoing transurethral resection of the prostate by Yung et al,9 anxiety was reduced for the music group, slightly for the
nurse present group, and no reduction was seen in
the control group. Again, with the small group of 30,
although a reduction in anxiety was found, the difference was not statistically significant.
As a means to reduce the ambulatory surgery patients preoperative anxiety, Augustin and Hains10
investigated music. STAI state portion was taken
on arrival to the center and before surgery. The
music group listened to music 15 to 30 minutes. Although there was a slight reduction in anxiety
from pretest to posttest, the music group had a statistically significant reduction (P #.005).

Nilsson et al5 looked at 75 subjects undergoing


open inguinal hernia repair. Subjects were randomized into three groups, intraoperative music,
postoperative music, and a control group, with
sham CD players. Stress response was assessed
during and after surgery using cortisol and blood
glucose levels. The postoperative music group exhibited decreased anxiety (P , .05) and pain
(P , .01). The intraoperative group experienced
decreased pain postoperatively compared with
the control group (P , .05).

Winter et al11 studied 62 women in the SDS gynecology unit. STAI was completed when they arrived
in the surgical holding area and again just before going to OR. The music group had a reduction of anxiety and stress after listening to music in the holding
area. The control group had an increase in anxiety
over the same period. The difference was significant, P , .05. All patients recommended that music be available for future patients.

Chlan et al6 studied anxiety and pain in outpatients


undergoing flexible sigmoidoscopy. Spielberger
et als State Trait Anxiety Inventory (STAI)7 was
used to measure anxiety. The STAI measures an individuals baseline trait anxiety as well as the temporary state anxiety of a given situation. There are
20 statements in each of the state and trait portions. The respondent evaluates each statement
as not at all, somewhat, moderately so, or very
much so. Music was listened to during the procedure. STAI was given preintervention to both
groups. The state portion was also administered
postintervention. A VAS with a rating scale of
0 to 10 was used to measure pain. There was a significant difference between the music group and

Similarly, Hayes et al12 studied 198 subjects to see if


self-selected music would reduce preprocedure
anxiety for patients undergoing colonoscopies
and esophagogastroduodenoscopies. Patients listened to music 15 minutes before the procedure.
Those randomly assigned to the no music group
had 15 minutes of quiet time. STAI was completed
only postintervention and before the procedure.
There was a significant difference in anxiety
(F 5 7.5; P 5 .007) between the two groups after
controlling for trait anxiety. In addition, patients
who listened to music were asked if they enjoyed
the music and if they felt relaxed after listening.
Ninety-seven percent enjoyed the music, and
89% stated that after listening they felt relaxed.

Author

Study Description

Population Sample

Measurement Instrument

148

Table 1. A Review of Research Using Music to Improve Patient Outcomes of Surgery or Special Procedures
Statistical Significance

Random, controlled experimental


study to test effects of music on
patients who listened to music
intraoperatively or
postoperatively

10 pts undergoing
microdiscectomies

VAS for pain and anxiety, pain


medication, questionnaire

Music groupNS
Questionnairevery
positive responses
Control groupNS

Nilsson et al5

RCT using sham and regular music


CDs with headphones
intraoperatively or
postoperatively to test stress,
immunity, anxiety, and pain
response during and after
general anesthesia

75 pts undergoing open inguinal


hernia repair under general
anesthesia

Cortisol, blood glucose levels; NRS


for pain and anxiety; BP, HR,
SpO2

Intraoperative music group


Anxiety decreased (P , .05)
Pain decreased (P , .05)
Pain med decreased (P , .01)
Postoperative music group
Anxiety decreased (P , .05)
Pain decreased (P , .01)
Cortisol decreased (P , .05)
Pain med decreased (P , .05)

Chlan et al6

RCT to test the effects of music on


anxiety, discomfort, satisfaction,
and perceived compliance with
colon cancer screening

64 outpatients undergoing flexible


sigmoidoscopy

STAI; VAS for pain

Music group
Anxiety decreased (P 5 .002)
Pain decreased (P 5 .026)
Control group
Anxiety increased

Andrada et al8

RCT using CDs with headphones


to assess the anxiolytic effect of
listening to music during
colonoscopies

118 pts receiving prescheduled


colonoscopies

STAI; BP, SpO2, HR

Music group
STAI decreased (P , .01)
BP (NS)
SpO2 (NS)
HR (NS)

Yung et al9

Quasi-experimental study to assess


anxiolytic effect of music or
nurse presence pre-op

30 pts undergoing TURP

State portion of the Chinese STAI

Music group
SBP decreased (P , .01)
DBP decreased (P , .04)
HR decreased (P , .01)
Anxiety decreased (NS)
Nurse presence
SBP decreased (NS)
DBP increased (NS)
HR decreased (NS)
Anxiety decreased (NS)

JOHNSON, RAYMOND, AND GOSS

Heiser et al4

Augustin and
Hains10

Quantitative experimental study to


investigate music reducing preop anxiety

42 ambulatory pts

VS; State portion of STAI

Music group
Anxiety decreased (P , .005)
DBP decreased (P , .005)
HR decreased (0.005)
RR decreased (P , .0005)
Control group
SBP decreased (P , .05)
DBP (NS)
HR (NS)
RR (NS)

Winter et al11

RCT to determine if music reduced


anxiety pre-op

62 SDS GYN pts

STAI, BP, HR

Music group
Anxiety decreased (P , .05)
BP (NS)
HR (NS)
Control groupNS

Hayes et al12

RCT to determine if music reduced


preprocedure anxiety for GI
procedures

198 pts undergoing EGD and


colonoscopy

STAI

Music group
Anxiety decreased (F 5 7.5
and P 5 .007)

Lukas13

Trial to determine if pts would


perceive listening to music
throughout perioperative
experience as a positive addition
to medication to control pain
and anxiety

31 outpatients undergoing
orthopaedic surgery

Investigator survey

97% positive experience

PERIOPERATIVE MUSIC

Control group
SBP increased (P , .01)
DBP increased (NS)
HR increased (P , .01)
Anxiety increased (NS)

Pts, patients; VAS, visual analog scale; NS, not significant; RCT, randomized controlled trial; NRS, numeric rating scale; BP, blood pressure; HR, heart rate; SpO2,
oxygen saturation; SBP, systolic blood pressure; DBP, diastolic blood pressure; VS, vital signs; RR, respiratory rate; STAI, State Trait Anxiety Inventory; TURP, transurethral resection of prostate; SDS, same-day surgery; GYN, gynecologic; GI, gastrointestinal; EGD, esophagogastroduodenoscopy.

149

JOHNSON, RAYMOND, AND GOSS

150

Lukas13 surveyed 31 patients perceived overall


experiences. This was the only study that allowed
patients to listen to music throughout the whole
perioperative experience. It was not a randomized
control test; however, 97% of the patients did express a positive experience.
The review of the literature strongly suggests that
the use of music therapy has a direct effect on the
reduction of stress and anxiety. In addition, a positive relationship in patients satisfaction with their
surgical experience after listening to music was
suggested. The studies reviewed, however, were
not clear if results were because of the music or
the blocking of noise.

Purpose
The purpose of this study was to determine the
effect of music versus use of noise-blocking headphones on anxiety levels in women undergoing
SDS for gynecologic procedures. This intervention
could in turn improve the overall patient experience. It was hypothesized that both music and
headphone-only groups would have a decrease in
anxiety, with the greatest decrease in the music
group. Additional information on pain medication
while in PACU was also collected.

Methods
Study Design and Setting
An experimental three-group design was used with
pre- and postmeasurement of anxiety. The Institutional Review Board approved the study, and data
collection was conducted over a 3-month period
in 2009. All data were collected at a singleinstitution, a 550-bed tertiary care, community hospital with two surgical areas. An average of 90 cases
per day is seen in the main OR and recovered in a 24bed PACU. The PACU serves both inpatient and outpatient surgical cases. The second operating area is
The Womens Center, specifically for gynecological
surgery. The Center averages 18 procedures per day
with patients recovered in an 11-bed PACU. Most of
the surgeries are outpatient and include both invasive and noninvasive procedures.
The study was conducted in The Womens Center
for several reasons: (1) control of participant demographics; (2) tighter study control; (3) studies

have shown that women are more likely to experience preoperative anxiety than men.1

Instruments
Most studies reviewed used the State Scale of the
STAI. Frequently, only the State Anxiety Score is
used, as it measures anxiety related to the current
situation. However, because the STAI includes 20
questions, it was not used for this study.
An alternative tool, the Rapid Assessment Anxiety
tool, has been used in a previous study of patients
preoperative anxiety.1 Developed and validated by
Benotsch et al,14 this single-item numeric rating
scale provides a quick assessment of anxiety that
would be valid and time friendly in the presence
of our fast-paced OR schedules. The tool also provided the ability to detect change as it rated responses from 0 (no anxiety) to 10 (most anxiety
possible). Furthermore, it was easy for patients
to understand as it mirrored the usual pain measurement format. The initial work on this tool
demonstrated that it correlated highly with STAI
State Score demonstrating validity (r 5 0.77) in
a sample of 197 patients evaluated preoperatively.
Postoperatively, the same subjects also completed
both anxiety tools with a slight decrease in
strength of relationship (r 5 0.69). The numeric
rating tool also demonstrated sensitivity to change
that mirrored the responsiveness of the STAI
20-item scale.

Inclusion/Exclusion Criteria
All women undergoing gynecologic surgery at The
Womens Center were included in the study if they
were older than 18 years, undergoing an outpatient procedure, and provided written consent to
participate. Women were excluded if they had
hearing problems that would preclude their ability
to listen to music. A sample size of 120 women was
determined using G Power program. Based on an
alpha of 0.05, power of 0.80, and effect size of
0.25, a total sample of 120 subjects would be
needed for the planned analysis. A repeated measure analysis of variance with three groups and
two time points was planned to answer the research question and used as the basis for the
power analysis.

PERIOPERATIVE MUSIC

151

Table 2. Comparison of Groups on Demographics and Select Variables of Interest


Demographics
Age
Number of medications
Number of previous surgeries
Minutes/day listening to music
Minutes in operating room
Minutes in PACU until Aldrete 2
Invasive procedure (%)
Pre-op routine anxiolytics (%)

Control (n 5 41)

Headphones (n 5 35)

Music (n 5 43)

38.44
2.2
2.41
194.7
60.7
17.4
48.8
4.9

36.83
2.11
2.97
180
56.6
15
37.1
5.7

40.91
2.34
2.27
212.2
60.5
21.5
61.4
6.8

PACU, postanesthesia care unit.


There were no significant differences among the groups on any of the above variables.

The procedure for this study was to initiate the


intervention preoperatively, continue into the
OR, and remain on in PACU until the patient was
awake at a level of consciousness (LOC) of 2 on
the Aldrete score.
The 120 women were approached for consent before their preoperative medication. After consent,
they were randomized to usual care, music with
headphones, or headphones only. Preoperative
anxiety was obtained using the Rapid Assessment
Anxiety tool, which rates anxiety on a scale of 0 to
10. Patients who received headsets only did not
have an MP3 player attached. The usual care group
received routine care given to all SDS patients.
Those in the music group selected one of three
types of music. Research suggests that the most
positive effects of music are found when the patient can choose the genre. Each of the five MP3
players was loaded with soft country, classical/
New Age, and inspirational music. Our team carefully reviewed all music for its appropriateness to
the setting. Any music that had extreme crescendos was eliminated. Headsets were chosen that
had padded ear covers. The MP3 player could be
set and locked keeping the volume at a constant
level.
Both music and headsets only were started in SDS
before preoperative medications. Both interventions were continued throughout surgery and
removed when Aldrete LOC equals 2. Post-op anxiety was then rated. One subject in the music
group refused to complete the postanxiety score
and was dropped from the analyses resulting in a

final total sample of 119 subjects. Additional comments from subjects were collected along with
a brief chart review of demographic information
and pain medication used in the PACU. The entire
headsets and MP3 players were sanitized with SaniCloth PLUS (Professional Disposables International, Inc., Two Nice-Pak Park Orangeburg, NY)
germicidal disposable cloths before and after use.

Results
The 119 women completing the study had a mean
age of 38.8 (standard deviation 5 2.2) years. There
were no significant differences in age or other
demographic characteristics by group (P ..05).
Table 2 provides general demographic information
for each of the three groups along with preoperative medication use and type of procedure performed.
To answer the research question, a repeated measure analysis of variance was performed using
Change in Anxiety
4.5
Level of Reported Anxiety (0-10)

Procedure for Data Collection

4
3.5
Control (n=41)

3
2.5

Music (n=43)

2
Headphones only
(n=35)

1.5
1
0.5
0

Pre-op Anxiety

Post -op Anxiety

Figure 1. Changes in anxiety from pre-op to postop for each group. All subjects included. This figure is
available in color online at www.jopan.org.

JOHNSON, RAYMOND, AND GOSS

152

Table 3. Comparison of All Subjects Anxiety Scores


All Subjects*
Preoperative
Postoperative
Change in anxiety

Control (n 5 41)

Headphones (n 5 35)

Music (n 5 43)

3.98 (2.3)
2.15 (2.5)
21.83 (2.5)

4.20 (2.7)
1.46 (1.8)
22.74 (2.6)

3.74 (2.4)
1.16 (2.2)
22.58 (2.5)

*F 5 1.47 (degrees of freedom 1,2); P 5 .244.

PASW Statistics 17 (IBM Corp, Portsmouth, Hampshire, UK). Figure 1 shows the change in anxiety
from pre-op to post-op for subjects by group. All
groups experienced a reduction in anxiety of
about 2 units, but there were no statistically significant group differences (F 5 1.47 [2,116];
P 5 .224). Table 3 depicts the preoperative anxiety
and postoperative anxiety scores by group as well
as the change scores.
On closer examination, it was discovered that 12%
reported no anxiety pre-op and 51% had very low
levels of pre-op anxiety. Low anxiety (0-3) was
equally represented among the three groups. The
data were reanalyzed using only those with moderate to high levels of pre-op anxiety ($4/10), and
these results are reported in Table 4. When examining those with moderate or high levels of preoperative anxiety, all groups experienced a drop
in anxiety from pre- to postoperative status, but
the control group had the smallest decrease
(F 5 3.5; P 5 .03; power 5 0.63). The music group
experienced the lowest postoperative anxiety
scores, but the headphone group had a slightly
greater overall change score because this group
had a slightly higher preoperative anxiety score
(Figure 2). This significance in anxiety reduction was similar to those studies previously reviewed4-6,8-13 where P values ranged from .05
to .002.
Many subjects offered comments and opinions related to the use of music or headphones. The only
negative comments were either from those who

did not get music or related to the preferred type


of music available. The comments were similar to
those seen in the studies reviewed.4-6,8-13 See
Table 5 for examples of patient comments.
Although it was not a research question for this
study, post hoc we did examine the use of analgesics in the PACU. All narcotics were changed to the
equianalgesic dosing for opioids equivalents using
the 2007 Pharmacists Letter conversion table.15
The control group had a higher mean dose of analgesics (4.01 mg) than either the headphones-only
group (3.6 mg) or the music group (2.92 mg). Although the use of analgesic was 28% less in the music group than in the control, it was not statistically
significant.

Discussion
Anxiety decreased after surgery; however, half
had low pre-op anxiety, making it difficult to see
the effect of music. This was surprising to us; however, as noted in the earlier study on anxiety, 35%
of women report feeling calm preoperatively.
Fifty-one percent of our participants had anxiety
ratings of 0 to 3. The fact that this unit is a new,
small, and women-only facility that focuses on
family-centered care may have had a calming effect
on the patients.
The team also considered the possibility of
measuring patient satisfaction. Patient satisfaction
was at the time just starting to be measured by
Press Ganey for outpatient procedures. Although

Table 4. Comparison of Subjects With Preoperative Anxiety Scores $4*


Subjects With Preoperative
Anxiety $4*

Control (n 5 17)

Headphones (n 5 15)

Music (n 5 19)

6.0 (1.5)
3.59 (3.1)
22.41 (3.6)

6.13 (1.6)
1.93 (1.9)
24.80 (2.0)

6.05 (1.0)
1.71 (2.8)
24.08 (2.8)

Preoperative
Postoperative
Change in anxiety
*F 5 3.41 (degrees of freedom 1,2); P 5 .04.

PERIOPERATIVE MUSIC

153

Change in Anxiety Level for Those with Moderate to


High Pre-op Anxiety
Level of Reported Anxiety (0-10)

8
7
6

Control (n=17)

5
Music (n=18)

Headphones
only (n=15)

3
2
1
0
Pre-op Anxiety

Post -op Anxiety

Figure 2. Change in anxiety score over time in


those with moderate or high pre-op anxiety (4-10/
10). This figure is available in color online at www
.jopan.org.

our goal was to ultimately improve the overall experience of the patient, we did not feel patients
should receive another questionnaire to fill out at
that time. We felt a reduction in anxiety was
a needed outcome and measurable.
Pain reduction was considered initially as a purpose
of the study. However, to truly explore the effects of
music on pain, everything else would need to be
controlled. The surgeon, the amount of marcaine
used in the incisions, the type of surgery being preformed, and the use of Toradol or other analgesics
preoperatively would all need to be controlled.
This did not appear to be feasible at our institution
at that time. In addition, the literature appeared to
have stronger support for anxiety reduction rather
than pain reduction (Table 1). The procedure of
starting the music in SDS and continuing it on into
the PACU is ideal. In our facility, we have continued
to offer music to preoperative patients in our
Womens Center. A sign in the pre-op room tells
patients they may ask for MP3 players. In addition,
we have SDS nurses who have seen the benefits of
the music and are initiating it. Keeping track of
the players is a challenge, and each unit adopting
this intervention should have a procedure in place
to track the patients and equipment. We are noting
on the chart the patient has one of the players. SDS
nurses are giving a patient sticker to PACU nurses so
that the PACU nurse can be watching for the player.
After each use, the PACU staff sanitizes and recharges the players.
At this time, we are implementing this procedure
in our main perioperative area. Patients attending

Table 5. Comments From Subjects


Usual care
 Would have preferred music (three)
 Brought own in past and found it beneficial to decrease anxiety
 I was not really worried about the procedure; it was
just being in a hospital
 Music is a great idea (two)
Headsets only
 Would have liked to have music (six)
 Headphones were annoying (seven)
 Helped to decrease anxiety pre-op (two)
Music
 I loved it. I would highly recommend it. It was
wonderful to wake up to music
 I love the music before but quiet after (two)
 It was calming, a good distraction. Helped me relax
pre-op
 I think it helped keep me calm
 I liked it (eight)
 Would have liked music earlier when too many family
members were in the room
 Best PACU experience ever had Earlier experience
with postoperative nausea and vomiting none this
time
 I would recommend this to anyone
 Would prefer music again if ever needed surgery
 Patient wanted it off in PACU because of waking up in
pain
 Would prefer jazz
 The headphones were too big and kept falling off my
headfrustrating
 Reported anxiety level 7 in PACU because of pain and
urgency to urinate
PACU, postanesthesia care unit.

pre-op classes are also given the opportunity to


bring in their own players. We have recently purchased enough players to place in each nurse
server in PACU. This way the players can be used
even if they have not received it before PACU.
Guided imagery for successful surgery has also
been added to our players since this study, at the
request of a patient.

Limitations
All subjects were given music before pre-op medication; however, some had the opportunity to

JOHNSON, RAYMOND, AND GOSS

154

listen longer than others preoperatively. We did


not collect data on this pre-op time. Subjects
gave their consent to participate in the study. If
a patient did not feel they would benefit from
the study, they chose not to participate. This narrows the study group to only those who would
like music. It may not reflect the population at
large.

tracter from the ambient noise of monitors, other


patients, staff, and equipment that routinely occurs in the perioperative areas. The intentional
use of music can be instrumental in transforming
the environment of the surgical patient into
a soothing and restful atmosphere to decrease
anxiety and promote healing.

Conclusion

Acknowledgments

Music is a relatively inexpensive intervention, easy


to administer, noninvasive, and found to be a satisfier for most people. In addition, it offers patients
a coping strategy giving them a sense of control
over an unfamiliar environment and creating a positive patient outcome. Music can function as a dis-

The authors acknowledge Linda S. Baas, PhD, RN, ACNP, Director of Nursing Research, The Christ Hospital, for her assistance
with the design of the study and the statistical analysis of the results; Joyce Burke, RN, BES, CPAN, PACU, Clinical Manager, for
her support throughout the study; and PACU nurses Lisa Haubner, RN, BSN, Diane Stapp, RN, and Kimberly Latham, RN, BSN,
CCRN, for their assistance with the study.

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