Implementing a Paced Deep Breathing Module to Decrease Preoperative Anxiety in Gynecological Surgery Patients
Phase: NA
Conditions: Anxiety
Sponsor: Mayo Clinic

Study Title: Implementing a Paced Deep Breathing Module to Decrease Preoperative Anxiety in 
Gynecological Surgery Patients 
 
This study aims to reduce preoperative anxiety in patients undergoing gynecological surgery by 
the implementation of a guided paced deep breathing module introduced into the preoperative 
setting. If this intervention is successful in reducing patient anxiety, we plan to implement into 
practice the guided paced deep breathing module that every patient is offered preoperatively. 
 
Principal Investigators: Dr. Susanne Cutshall, APRN, CNS, D.N.P.; Natalie Laska, RN, SRNA 
 
Co-Investigators: LaChelle Wieme, APRN, CRNA; Dr. Mary Shirk Marienau, APRN, CRNA, 
Ph.D.; Dr. Amit Sood, M.D.; Saswati Mahapatra; Heather Ondler Hinson 
 
Each member of the study team is in compliance with Mayo Clinic Institutional Review Board 
Human Subjects Training. The study is supported by the staff on Eisenberg 1-4, the Doctor of 
Nurse Anesthesia Practice program faculty and staff in the Complementary and Integrative 
Medicine Program. 
 
Document date: February 20, 2017 
 
 

Abstract 
 
 
Preoperative anxiety is a common occurrence for many patients undergoing all types of 
surgery.1,2 Patients with a high level of anxiety before surgery have been shown to have 
numerous negative outcomes both intra-operatively and post-operatively.3-10 Many studies have 
shown that preoperative psychological interventions that aim to reduce anxiety also result in 
improved post-operative behavioral and clinical recovery.8 Currently, the most common method 
to treat preoperative anxiety is the administration of a prescription benzodiazepine.11 However, 
there is limited clinical evidence that supports the use of sedative premedication, such as with a 
benzodiazepine, before surgery.12 Complementary integrative medical therapies including music, 
massage, guided imagery, and deep breathing have been proposed to minimize stress and pain in 
surgical patients.13,14 These therapies are thought to be effective by evoking the relaxation 
response through stimulation of the parasympathetic nervous system and engagement of the 
patient in the healing process.14 Relaxation and deep breathing, particularly, have been shown to 
reduce pain, anxiety, and “tension-anxiety” in hospitalized patients.14,15 Based on this evidence, a 
guided paced deep breathing module has been proposed to reduce preoperative anxiety in 
patients undergoing gynecological surgery at Mayo Clinic Rochester Methodist Hospital. In this 
study, patients’ anxiety will be assessed pre-intervention on a 0-10 numeric rating scale, as well 
as post-intervention and a paired t-test will be used to assess effectiveness. Additionally, 
qualitative questions will be administered via a questionnaire post-intervention to gain more 
insight on the effectiveness of the intervention. The feasibility of the intervention in the busy 
preoperative setting will be evaluated by assessing how many times a patient is interrupted while 
participating in the paced deep breathing module. If this module is found to be effective in 
reducing patients’ anxiety, it will be implemented into practice so that every patient is offered the 
module preoperatively. 
 
Research Plan 
 
I. 
Background and Significance: 
 
Pre-operative anxiety is a common occurrence for many patients undergoing all 
types of surgery. Fears concerning the anesthesia process, fear of death or being cut, 
of a poor prognosis, fear of pain and no access to pain medications after the surgical 
procedure combined with fear of the unknown and loss of control all contribute to 
excess preoperative anxiety.1,2 Patients with high anxiety before surgery have been 
shown to have numerous negative outcomes both intra-operatively and post-
operatively. These include increased doses of anesthesia induction agent required to 
achieve loss of consciousness,3,4 increased post-operative pain scores5,6 and analgesic 
use,6 increased in-hospital mortality and major morbidity,7 increased cost and length 
of stay,8 increased rates of surgical site infections,8 and decreased overall patient 
well-being and satisfaction.9,10  
Many studies have shown that pre-operative psychological interventions that aim 
to reduce anxiety also result in improved post-operative behavioral and clinical 
recovery.8 Currently, the most common method to treat preoperative anxiety is the 
administration of a prescription benzodiazepine. However, because of the temporary 

effect of this medication and its side-effects, this method may not be the best 
treatment.11 There is limited clinical evidence that supports the use of sedative 
premedication, such as with a benzodiazepine, before surgery.12 In a well-designed 
randomized controlled trial, patients treated preoperatively with 2.5mg of lorazepam 
were shown to have a prolonged time to extubation and decreased rate of early 
cognitive recovery. Additionally, the study found that premedication with lorazepam 
did not improve patient satisfaction.12 
 
Complementary integrative medical therapies including music, massage, guided 
imagery, and deep breathing have been proposed to minimize stress and pain in 
surgical patients.13,14 These therapies are thought to be effective by evoking the 
relaxation response through stimulation of the parasympathetic nervous system and 
engagement of the patient in the healing process.14 Relaxation and deep breathing, 
particularly, have been shown to reduce pain, anxiety, and “tension-anxiety” in 
hospitalized patients.14,15 
 
Based on this evidence, an electronic paced deep breathing module has been 
proposed to reduce preoperative anxiety in patients undergoing gynecological surgery 
at Mayo Clinic Rochester Methodist Hospital. The gynecological surgery population 
has been selected because of research suggesting women tend to have a higher level 
of anxiety before surgery and may be more receptive to relaxation exercises.16-18 
Additionally,  women undergoing gynecological surgery were found to have an 
average anxiety rating of four on a zero to ten numeric rating scale.17  
 
II. 
Purpose of the Study: 
 
The purpose of this study is to evaluate the effectiveness of an electronic guided 
paced deep breathing module implemented into the preoperative setting of 
gynecological surgery to reduce patient anxiety. If this intervention is found to be 
effective, we plan to implement into practice the paced deep breathing module that 
every patient is offered preoperatively. 
 
III. 
Specific Aims of the Study:  
 
Primary Aim: The study’s primary aim is to assess if utilizing an electronic paced 
deep breathing module administered in the preoperative setting can decrease a 
patient’s anxiety level prior to undergoing gynecological surgery. This study will 
determine if more research is needed or if the results are overwhelmingly positive in 
reducing anxiety, we plan to implement into practice the paced deep breathing 
module that every patient is offered preoperatively. 
 
Secondary Aim: The secondary aim of this study is to collect qualitative data 
regarding patient satisfaction with the paced deep breathing module. 
 
Tertiary Aim: The tertiary aim of this study is to evaluate the feasibility of 
implementing a paced deep breathing module into the busy preoperative setting of 
gynecological surgery. 
 

Hypothesis: In adult females undergoing gynecological surgery, the use of a 
preoperative electronic guided paced deep breathing module will decrease anxiety 
levels. 
 
IV. 
Literature Review: 
 
The clinical practice question was used to guide the literature search. Preliminarily, 
PubMed was searched to determine if anxiety before surgery was, in fact, a problem. 
Key terms included perioperative period combined with anxiety or distress and 
outcomes or effects. Limitations included only articles that had been peer-reviewed 
and were available in English between January 1, 2005 and December 31, 2015. 
Next, the clinical practice question was searched using databases: CINAHL, Embase, 
PubMed and PsycINFO covering a period of the last ten years, 2005 to 2016. Key 
search terms included variations of preoperative period combined with breathing 
exercises or meditation or guided imagery and anxiety or distress. Limits were set to 
only include articles that had been peer-reviewed and were available in English. 
Additionally, National Guideline Clearinghouse, Cochrane Collaboration, Joanna 
Briggs Institute and the Anesthesia Patient Safety Foundation were searched for 
practice guidelines pertaining to the subject, but none existed. Of the articles 
reviewed, selections for included articles were made for relevance, availability, and 
application to the adult population. The reference lists of the selected articles were 
then reviewed for additional articles that were deemed important to be included. 
Additionally, expert opinion was sought for inclusion of articles pertaining 
particularly to complementary and integrative medicine modalities. 
 
Through appraisal of this evidence commonalities were identified, along with similar 
research methods, and a predominant level of evidence emerged. A total of 21 articles 
regarding complementary and integrative therapies implemented to decrease anxiety 
in the hospital setting have been reviewed. Interventions varied from educational 
interventions, guided deep breathing exercises, guided imagery, music interventions, 
to massage, either individually or in combination with other therapies. Ten of the 21 
articles specifically mentioned a guided breathing intervention.13, 15, 18-25 Different 
modalities were utilized to deliver the interventions including audio CDs, pamphlets, 
instruction from providers, and iPads or iPods. Of the ten articles reviewed 
investigating a breathing intervention specifically, five included interventions that 
were administered before surgery18,19,22,24,25 and the remaining offered therapies 
during procedures such as dressing changes,15 chemotherapy,13 gynecology exams,20 
hospitalization for stem cell transplant21 and patients suffering from panic attacks.23 
Of the studies offering pre-operative interventions, they were offered approximately 
one day before surgery18,19,22,24,25 and some continued post-operatively.22,24 The types 
of surgery involved in the studies that offered a breathing intervention pre-operatively 
included trauma and orthopedic surgery19,22 including joint replacements,24 as well as 
coronary artery bypass grafting.25 
 
Of the outcomes measured in the breathing intervention studies, the majority of 
studies included a primary outcome of anxiety,15,18-25 or tension-anxiety13 as well as 

various secondary physiological outcomes such as systolic and diastolic blood 
pressure and heart rate18,20,24. Other secondary measures included pain,15, 19,22,24,25 self-
efficacy,19 fatigue,13 sleep satisfaction,22 and depression.21, 23 Scales used to measure 
the primary outcome of anxiety included Spielberger’s State-Trait Anxiety Inventory-
State Scale,18,19,21,22,24 Visual Analog Scales,15,24 the Beck Anxiety Inventory,25 the 
Episodic Anxiety Scale23 and numeric rating scales.20  
 
Similar research methods were utilized in many of the articles. The majority of 
studies, nine of ten, were well-designed single or multi-site randomized controlled 
trials,13,21,23-25 or quasi-experimental trials15,18,19, 22 with a predominant Level of 
evidence at II or III. One Level IV study was found—a pilot study.20 
 
 
While consulting the evidence, themes were identified supporting complementary and 
integrative therapies, especially guided deep breathing exercises, to reduce anxiety in 
the preoperative period. Of the ten studies that focused on guided breathing exercises 
specifically, nine found statistically significant reductions in anxiety.13,15,18,19-23,25 Of 
the five studies also investigating changes in pain scores post-intervention, all but one 
found statistically significant reductions.15,19,22,24 Additionally, of the three studies 
also measuring physiological changes in outcomes such as systolic and diastolic 
blood pressure, heart rate, and respiratory rate all three found positive statistically 
significant physiological improvements in the intervention group.18,20,24 Statistically 
significant improvements were also seen in self-efficacy,19 fatigue,13 depression,21,23 
and sleep satisfaction22 in the intervention groups. 
 
Trends were seen supporting complementary integrative therapies such as guided 
deep breathing exercises to be effective in reducing anxiety in the preoperative 
period, but results didn’t necessarily translate post-operatively. However, of the 
qualitative data that was collected, all comments and patient experiences were 
positive with no safety concerns that arose. Common themes were helpfulness of the 
intervention and induced relaxation the patient felt after the intervention. 
Additionally, gender effects emerged with women reporting higher levels of anxiety 
preoperatively than males and relaxation techniques having a more profound effect on 
women than men.16,18 
 
Considering this evidence, the implementation of a paced deep breathing module in 
the preoperative period to reduce anxiety in women undergoing gynecological 
surgery is supported. Based on this literature review, the research team hypothesizes 
this intervention to be very effective in reducing patient anxiety. Paced deep 
breathing has been selected as the complementary therapy to reduce anxiety because 
of the overwhelmingly positive results that were seen while conducting this literature 
review. Ninety percent of the studies reviewed that looked specifically at guided 
breathing exercises to reduce anxiety in the hospital setting found statistically 
significant results. This intervention, additionally, has been found to be cost-effective 
and easy to implement. Furthermore, female patients undergoing gynecological 
surgery have been selected because of the gender effects observed in the literature.16-
18 

 
V. 
Theoretical Framework:  
 
The theoretical model being used for this study is Herbert Benson’s relaxation 
response. The relaxation response is defined as physiological changes that are 
provoked by assuming a relaxed position in a quiet environment, closing one’s eyes, 
engaging in repetitive mental action and passively ignoring distracting thoughts.26 The 
physiological changes associated with the relaxation response are consistent with 
decreased sympathetic nervous system activity and include decreased oxygen 
consumption, heart rate, arterial blood pressure, respiratory rate and arterial blood 
lactate.26 Patients participating in the present study will be instructed to resume a 
relaxed position in a quiet, dimly-lit environment, close their eyes and focus their 
attention on the repetitive nature of their inhalation and exhalation. The goal is to 
invoke the relaxation response and lower preoperative anxiety to reduce negative 
outcomes that have been associated with high levels of anxiety going into surgery. 
 
Additionally, the Neuman Systems Model can be applied. “The Neuman Systems 
Model is a systemic perspective of health and wellness, defined as the condition or 
the degree of system stability, that is, the condition in which all parts and subparts 
(variables) are in balance or harmony with the whole of the client/client system.”27, 
p.12 The model is based on the individual’s continuous relationship to environmental 
stress factors. These environmental stress factors have the potential to cause a 
reaction or a symptomatic reaction to stress thus affecting the client’s current health 
status.27 This model relates to the present study in that the patient is being treated in a 
holistic manner on the basis that anxiety before surgery has negative outcomes both 
intra-operatively and post-operatively, thus preoperatively treating the patient’s 
anxiety with the deep breathing module will, in turn, positively benefit the patient’s 
health status. 
 
VI. 
Significance: 
 
Guided deep breathing has been found to be effective in reducing patient anxiety in 
the hospital setting, including during the preoperative period. However, this will be 
the first study to implement a guided deep breathing focused intervention into the 
immediate preoperative period for gynecological surgery patients to determine its 
effectiveness on reducing anxiety and evaluate patient satisfaction. Currently, 
gynecological surgery does not offer any such intervention. This will be the first 
approach to reduce patients’ preoperative anxiety with a deep breathing intervention. 
This study has the potential to significantly add to the evidence and literature 
supporting the potential benefits of paced deep breathing exercises in the immediate 
preoperative setting. It will also provide a baseline for continued research on the 
benefits of paced deep breathing utilized in the immediate preoperative setting in 
specialty practices other than gynecological surgery.  
 
VII. 
Methods: 
 

This is a study with a pre- and post-test quasi-experimental design. This study will 
specifically examine an electronic paced deep breathing module for adult female 
patients undergoing gynecological surgery in the preoperative setting. This pre/post-
test design was chosen to measure the primary outcome of anxiety level and gain 
patient’s feedback on the module, as well as evaluate the feasibility of implementing 
the module into the busy preoperative setting of gynecological surgery. 
 
a. Subjects and setting:  
 
The study will be offered to a convenience sample of 45 adult female patients in 
the preoperative area of gynecological surgery on Eisenberg 1-4 at Mayo Clinic 
Rochester Methodist Hospital. This unit has approximately ten private rooms 
where patients are called from the outpatient AM admit area or hospital room to 
be evaluated and wait until called into the operating room for surgery. All patients 
undergoing gynecological surgery pass through this unit. According to nurses 
working on Eisenberg 1-4, the average length of stay in these rooms is about one 
hour. 
 All patients recruited will be assigned to the intervention group, as there is no 
control group. The sample size for this investigation was determined for the 
primary outcome of anxiety assessed pre- and post-intervention. From previous 
investigations which have assessed interventions aimed at reducing anxiety in 
surgical patients, the magnitude of the effect (i.e. change in anxiety expressed in 
SD units), has ranged from 0.5 to 0.9.18,19  In general, for a one-sample study a 
sample-size of N=45 will provide statistical power (two-tailed, alpha=0.05) of 
90% to detect a change of 0.5 SD. Therefore a sample-size of N=45 is proposed.  
 
Inclusion Criteria: Women aged 18 years or older undergoing gynecological 
surgery on Eisenberg 1-4; English-speaking; Able to complete pre- and post-
intervention questionnaires; Able to read and understand informed consent form 
 
Exclusion Criteria: Non-English speaking women; first-case of the day 
gynecological surgery patients 
 
b. Instruments and Data Collection (See Appendix): 
 
1. Rapid Anxiety Assessment Tool (RAAT) 0-10 numeric rating scale 
2. Qualitative questions regarding paced deep breathing module 
3. Demographic data collected on pre-intervention survey 
 
Baseline anxiety will be assessed upon admission to Eisenberg 1-4 using the 
Rapid Anxiety Assessment Tool (RAAT) zero to ten numeric rating scale and 
demographic information will be collected. This tool has been validated in the 
literature and is a single-item numeric rating scale that provides a quick 
assessment of patients’ anxiety level.17 The tool rates anxiety on a zero (no 
anxiety) to ten (worst anxiety possible) numeric scale and is easy for patients to 
use.17 The tool additionally has been correlated with Spielberger’s State-Trait 

Anxiety Inventory-State Scale with r=0.77 validity in a sample of 197 patients 
evaluated in the preoperative period.17  
Demographic data for the study population will be collected on the pre-intervention 
questionnaire including age, diagnosis, type of surgery, and whether the patient has 
utilized deep breathing or meditation exercises within the last twelve months. After 
the intervention, anxiety will be assessed again using the RAAT numeric rating 
scale and qualitative questions regarding the module will be assessed. Data will be 
collected from paper questionnaires. 
Feasibility will be assessed by determining if and how many times each patient 
was interrupted while using the paced deep breathing module. 
 
 
    c.   Procedures: 
Patients will be recruited by primary investigators, Natalie Laska, RN, SRNA, 
and Dr. Susanne Cutshall, APRN, CNS, D.N.P., as well as co-investigator, 
Heather Ondler Hinson, by the assistance of a research flyer (see appendix). 
Additionally, a surgical listing of patients undergoing gynecological surgery for 
each day will be obtained by the primary investigators or co-investogator. 
Inclusion/exclusion criteria will be evaluated to determine eligibility and eligible 
patients will be approached by the primary investigators/co-investigator and asked 
if one is interested in participating in a deep breathing/meditation intervention. 
The primary investigators/co-investigator will then provide information and 
instruction regarding the questionnaires and intervention module to the patient. 
The patient will then be asked for verbal consent and written signed HIPAA 
authorization to participate. Once consent is obtained, the primary 
investigators/co-investigator will provide the patient with the questionnaire packet 
(including pre- and post-intervention questionnaires) as well as introduce and set 
up the module on an iPad or portable laptop for the patient. The paced deep 
breathing module consists of ten minutes of a guided breathing exercise while 
culminating a calm and energized mind. It was developed by Dr. Amit Sood, 
M.D. and is entitled “Calm and Energize: A Meditation with Your Breath.” The 
script for this meditation is led by Dr. Sood and is as follows: 
“Calm and energize, a meditation with your breath. Let us settle ourselves 
in a quiet, safe and comfortable place. Start your practice by welcoming 
this lovely hibiscus that is slowly waking up to the world. Notice the five 
overlapping petals. Notice their color—the shallow wrinkles on their 
surface and folded frilly edges (video of hibiscus flower opening is 
shown). Like this flower, imagine you have opened your heart to invite 
hope and possibilities into your life. When you’re ready, gently close your 
eyes making sure your eyelids are only lightly touching each other. Now, 
gradually shift your attention to the rhythm of your breath. Observe the 
flow of your breath without trying to change it in any way. Notice the 
subtle sensation of air flow under your nostrils as you breathe in fresh, 
cool air and breathe out air that is warmed by your lungs. Next, we will 
synchronize our breath to the two flute sounds. This is the sound for 
breathing in (pause for flute sound) and this is the sound for breathing out 
(pause for flute sound). Begin slow deep breathing synchronizing your 

breath to the two flute sounds. Inhale (flute), exhale (flute), inhale (flute), 
exhale (flute), inhale (flute), exhale (flute). Make sure your eyes are 
relaxed with your eyelids only lightly touching each other and your face 
has a gentle smile.  Now we will calm and energize our heart. Follow your 
breath from the tip of your nose to the deepest place in your heart. While 
breathing in, imagine your heart is recharging with calming, soothing 
energy. While breathing out, imagine your fatigue and hurt are all melting 
away. Inhale (flute), exhale (flute), inhale (flute), exhale (flute), inhale 
(flute), exhale (flute continues without instruction).  Make sure your eyes 
are relaxed with your eyelids only lightly touching each other and your 
face has a gentle smile. Now, we will calm and energize our eyes. Follow 
your breath from the depth of your heart to both of your eyes. While 
breathing in, imagine your eyes are recharging with calming, soothing 
energy. While breathing out, imagine all the fatigue in your eyes is 
melting away. Inhale (flute), exhale (flute), inhale (flute), exhale (flute), 
inhale (flute), exhale (flute continues without instruction). Make sure your 
eyes are relaxed with your eyelids only lightly touching each other and 
your face has a gentle smile. Now, we will calm and energize our brain. 
Follow your breath from the depth of your heart to the farthest places in 
your brain. While breathing in, imagine your brain is recharging with 
calming, soothing energy. While breathing out, imagine all the fatigue in 
your brain is melting away. Inhale (flute), exhale (flute), inhale (flute), 
exhale (flute), inhale (flute), exhale (flute continues without instruction). 
Make sure your eyes are relaxed with your eyelids only lightly touching 
each other and your face has a gentle smile (flute continues). Now, think 
about one person you know who truly cares about you. Bring that person’s 
face in front of your eyes, and then send that person your silent gratitude. 
Imagine that person is being protected for the week with the energy you 
just sent. We will now transition out of the meditation practice. Give 
yourself a nice stretch, set a positive intention for the rest of the day, and 
then when you’re ready you can open your eyes. I hope you have a 
wonderful day.” 
During this time, the patient will be left alone with the door shut and lights 
dimmed.  Family present in the room will be welcome to stay. A door card will be 
placed outside the room to minimize interruptions during this time. At the 
completion of the module, a second anxiety score using the RAAT numeric rating 
scale will be collected and a short questionnaire will be completed (see appendix). 
A nurse on Eisenberg 1-4 will collect the completed questionnaire packet from 
each participating patient, to reduce bias, and bring to the primary 
investigators/co-investigator for secure filing. Information as to whether the 
patient received a benzodiazepine in the preoperative setting will be collected 
from the patient’s medication administration record. Prior to the implementation 
of the study, nurses on Eisenberg 1-4 will be introduced to the intervention 
module and have the study explained. Julie Somheil, the nurse manager of the 
unit, has already shown support of the study and informed nurses on the unit 

about it. While observing on this unit, primary investigators have already received 
support and positive feedback regarding the study from many nurses. 
 
Natalie Laska, RN, SRNA along with Dr. Susanne Cutshall, APRN, CNS, D.N.P. 
or Heather Ondler Hinson will be approaching patients individually and 
consenting them to participate in the study the day of surgery, as well as explain 
the module and questionnaires to patients and deliver the questionnaire packet. 
Nurses on EI 1-4 will collect the completed questionnaire packets and bring them 
to primary investigators/co-investigator. All study materials will be kept in a 
secured file by the primary investigators/co-investigator. Data analysis will be 
performed by Natalie Laska, RN, SRNA, with assistance from the statistician, 
Darrell Schroeder. 
 
The only potential risk factor foreseen is emotional harm by feeling distressed 
from answering the questionnaires. If a patient chooses not to participate or end 
participation early, his or her care will not be compromised. 
 
 
     d.   Data Analysis: 
 
Subject characteristics will be summarized using mean±SD for continuous 
variables and frequency counts and percentages for categorical variables. The 
primary outcome for this study will be anxiety which will be assessed pre- and 
post-intervention using RAAT (0-10 numeric rating scale). The change from pre- 
to post-intervention will be assessed using the paired t-test (or signed rank test).  
Results from the short post-intervention survey will be summarized using 
methods appropriate for qualitative data collection including content analysis 
dividing responses into meaning units, condensing these and interpreting the 
underlying meaning to identify sub-themes and themes.28 
 
 
    e.   Limitations: 
 
 This is a study with no control group using a convenience sample 
 Small sample size 
 Limited generalizability 
 
VIII. Human Subjects Consideration: 
 
a. Potential Risks: 
 
The potential risks of this research study are minimal. In previous studies utilizing 
deep breathing practices, no side effects were observed. There is no compromise 
to present or future care if the patients refuse the offer of the paced deep breathing 
intervention or if the intervention is stopped early.  Patients will be given the 
option to stop the intervention at any time if they have concerns or feel 
uncomfortable. 
 

b. Protection: 
 
We will adhere to HIPAA regulations and protect the privacy and confidentiality 
of the patients involved from recruitment, intervention, and analysis of data.  If at 
any time a participating patient exhibits signs of distress, the subject will then be 
given the choice to either continue or discontinue with the paced deep breathing 
intervention. All study participants will be given a unique ID code separate from 
their MC number and all data will be kept in a secured file and secure electronic 
server. 
 
c. Gender/minority Mix: 
 
English as the primary language is a necessity for this small sample size study due 
to the nature of excluding the need for an interpreter to interpret the pre- and post-
intervention questionnaires. 
 
IX. Appendix 
 
a. Timeline:  
i. Complete nursing research ancillary committee review- July 2016 
ii. Turn in to IRB- August 2016 
iii. Start study- when primary investigators are available- March 2017 
iv. Complete study by end of May 2017 
v. Review study results and surveys- June-September 2017 
vi. Begin writing results of study for publication- October 2017-January 2018 
vii. Dissemination of results via oral and poster presentations-Spring/Fall 2018 
viii. Apply for publication- Winter 2018/2019 
 
b. Budget:  
 
No budget is needed for this project. No monies are currently being requested for 
statistical support or data entry.  Data will be abstracted and entered into 
spreadsheets/Redcap by co-investigators. The Center for Clinical and 
Translational Science (CCaTS) Research Resources will assist with the statistical 
analysis. An iPad will be rented through media support services. A poster will be 
generated to disseminate results.  Per institutional guidelines for poster 
development and preparation, Media Support Services will provide support and 
print the poster at no charge.  
 
 
 
 
 

 
References 
 
1. 
Merakou K, Varouxi G, Barbouni A, et al. Blood Pressure and Heart Rate Alterations 
through Music in Patients Undergoing Cataract Surgery in Greece. Ophthalmol Eye Dis. 
2015;7:7-12. 
2. 
Gonzales EA, Ledesma RJA, McAllister DJ, Perry SM, Dyer CA, Maye JP. Effects of 
guided imagery on postoperative outcomes in patients undergoing same-day surgical 
procedures: a randomized, single-blind study. AANA J. 2010;78(3):181-188 188p. 
3.  
Kil HK, Kim WO, Chung WY, Kim GH, Seo H, Hong JY. Preoperative anxiety and pain 
sensitivity are independent predictors of propofol and sevoflurane requirements in 
general anaesthesia. Br. J. Anaesth. Jan 2012;108(1):119-125. 
4. 
Kim YH, Choi WJ. Effect of preoperative anxiety on spectral entropy during induction 
with propofol. Korean J Anesthesiol. Aug 2013;65(2):108-113. 
5. 
Theunissen M, Peters ML, Bruce J, Gramke HF, Marcus MA. Preoperative anxiety and 
catastrophizing: a systematic review and meta-analysis of the association with chronic 
postsurgical pain. Clin. J. Pain. Nov-Dec 2012;28(9):819-841. 
6. 
Vaughn F, Wichowski H, Bosworth G. Does preoperative anxiety level predict 
postoperative pain? AORN J. Mar 2007;85(3):589-604. 
7. 
Williams JB, Alexander KP, Morin JF, et al. Preoperative anxiety as a predictor of 
mortality and major morbidity in patients aged >70 years undergoing cardiac surgery. 
Am. J. Cardiol. Jan 1 2013;111(1):137-142. 
8. 
Levandovski R, Ferreira MB, Hidalgo MP, Konrath CA, da Silva DL, Caumo W. Impact 
of preoperative anxiolytic on surgical site infection in patients undergoing abdominal 
hysterectomy. Am. J. Infect. Control. Dec 2008;36(10):718-726. 
9. 
Kagan I, Bar-Tal Y. The effect of preoperative uncertainty and anxiety on short-term 
recovery after elective arthroplasty. J. Clin. Nurs. Mar 2008;17(5):576-583. 
10. 
Hobson JA, Slade P, Wrench IJ, Power L. Preoperative anxiety and postoperative 
satisfaction in women undergoing elective caesarean section. Int J Obstet Anesth. Jan 
2006;15(1):18-23. 
11. 
Foji S, Tadayonfar MA, Mohsenpour M, Rakhshani MH. The study of the effect of 
guided imagery on pain, anxiety and some other hemodynamic factors in patients 
undergoing coronary angiography. Complementary Therapies in Clinical Practice. 01 
May 2015;21(2):119-123. 
12. 
Maurice-Szamburski A, Auquier P, Viarre-Oreal V, et al. Effect of sedative 
premedication on patient experience after general anesthesia: a randomized clinical trial. 
JAMA. Mar 3 2015;313(9):916-925. 
13. 
Hayama Y, Inoue T. The effects of deep breathing on 'tension-anxiety' and fatigue in 
cancer patients undergoing adjuvant chemotherapy. Complement Ther Clin Pract. May 
2012;18(2):94-98. 
14. 
Kshettry VR, Carole LF, Henly SJ, Sendelbach S, Kummer B. Complementary 
alternative medical therapies for heart surgery patients: feasibility, safety, and impact. 
Ann. Thorac. Surg. Jan 2006;81(1):201-205. 
15. 
Park E, Oh H, Kim T. The effects of relaxation breathing on procedural pain and anxiety 
during burn care. Burns. Sep 2013;39(6):1101-1106. 

16. 
Sears SR, Bolton S, Bell KL. Evaluation of "Steps to Surgical Success" (STEPS): a 
holistic perioperative medicine program to manage pain and anxiety related to surgery. 
Holist. Nurs. Pract. 2013 2013;27(6):349-357. 
17. 
Johnson B, Raymond S, Goss J. Perioperative Music or Headsets to Decrease Anxiety. J. 
Perianesth. Nurs. 2012;27(3):146-154. 
18. 
Ko Y-L, Lin P-C. The effect of using a relaxation tape on pulse, respiration, blood 
pressure and anxiety levels of surgical patients. J. Clin. Nurs. 2012;21(5/6):689-697 
689p. 
19.  
Wong EM, Chan SW, Chair S. Effectiveness of an educational intervention on levels of 
pain, anxiety  and self-efficacy for patients with musculoskeletal trauma. J. Adv. Nurs. 
2010;66(5):1120-1131 1112p. 
20.  
Sand-Jecklin K. Patient anxiety levels related to gynecologic examinations: use of the 
color breathwork relaxation method. Arch. Psychiatr. Nurs. Aug 2008;22(4):240-242. 
21. 
Kim SD, Kim HS. Effects of a relaxation breathing exercise on anxiety, depression, and 
leukocyte in hemopoietic stem cell transplantation patients. Cancer Nurs. Jan-Feb 
2005;28(1):79-83. 
22. 
Wong EM-L, Chair S-Y, Leung DYP, Chan SW-C. Can a brief educational intervention 
improve sleep and anxiety outcomes for emergency orthopaedic surgical patients? 
Contemporary Nurse: A Journal for the Australian Nursing Profession. 
2014;47(1/2):132-143 112p. 
23. 
Kim S, Roth WT, Wollburg E. Effects of therapeutic relationship, expectancy, and 
credibility in breathing therapies for anxiety. Bull. Menninger Clin. Jun 2015;79(2):116-
130. 
24. 
Lin P-C. An evaluation of the effectiveness of relaxation therapy for patients receiving 
joint replacement surgery. J. Clin. Nurs. Mar 2012;21(5-6):601-608. 
25. 
Garbossa A, Maldaner E, Mortari DM, Biasi J, Leguisamo CP. Effects of 
physiotherapeutic instructions on anxiety of CABG patients. Rev Bras Cir Cardiovasc. 
Jul-Sep 2009;24(3):359-366. 
26.  
Hoffman JW, Benson H, Arns PA, et al. Reduced Sympathetic Nervous System 
Responsivity Associated with the Relaxation Response. Science. 1982;215(4529):190-
192. 
27. 
Neuman BM, Fawcett J. The Neuman systems model: Pearson Education, Incorporated; 
2002. 
28. 
Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, 
procedures and measures to achieve trustworthiness. Nurse Educ. Today. Feb 
2004;24(2):105-112.