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The Effect of Music Therapy After Bariatric Surgery on Postoperative Nausea Vomiting and Patient Satisfaction (BSMusicPONV)

Primary Purpose

Bariatric Surgery

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Music Therapy
Sponsored by
Sibel Yilmaz Sahin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bariatric Surgery focused on measuring bariatric surgery, music therapy, nausea and vomiting, postoperative, nursing care

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Cognitive functions are sufficient, Able to communicate in Turkish, Between the ages of 18-80, Patients who voluntarily participated in the study Exclusion Criteria: Patients who did not volunteer for the study, Patients who underwent open surgery whose mother tongue is not Turkish

Sites / Locations

  • University of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Music Therapy

No Intervention

Arm Description

30 Minutes before evaluate PONV at 2nd,4th,6th,12th,24th hours

No intervention performed PONV evaluated at 2nd,4th,6th,12th,24th hours

Outcomes

Primary Outcome Measures

Postoperative Nausea and Vomiting
Simplified postoperative nausea and vomiting impact scale Developed by Myles and Wengritzky in 2012 and consisting of two questions, there are four options for each question that can be scored 0, 1, 2, 3 points. The first question asks whether there is vomiting or retching, if so, the frequency, and the answers are "0" no, "1" once, "2" twice, "3" three or more times and have four choices. In the second question, it is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are "0" not much, "1" sometimes, "2" often or often, "3" always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines "clinically significant nausea and vomiting".
Postoperative Nausea and Vomiting
Simplified postoperative nausea and vomiting impact scale Developed by Myles and Wengritzky in 2012 and consisting of two questions, there are four options for each question that can be scored 0, 1, 2, 3 points. The first question asks whether there is vomiting or retching, if so, the frequency, and the answers are "0" no, "1" once, "2" twice, "3" three or more times and have four choices. In the second question, it is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are "0" not much, "1" sometimes, "2" often or often, "3" always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines "clinically significant nausea and vomiting".
Postoperative Nausea and Vomiting
Simplified postoperative nausea and vomiting impact scale Developed by Myles and Wengritzky in 2012 and consisting of two questions, there are four options for each question that can be scored 0, 1, 2, 3 points. The first question asks whether there is vomiting or retching, if so, the frequency, and the answers are "0" no, "1" once, "2" twice, "3" three or more times and have four choices. In the second question, it is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are "0" not much, "1" sometimes, "2" often or often, "3" always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines "clinically significant nausea and vomiting".
Postoperative Nausea and Vomiting
Simplified postoperative nausea and vomiting impact scale Developed by Myles and Wengritzky in 2012 and consisting of two questions, there are four options for each question that can be scored 0, 1, 2, 3 points. The first question asks whether there is vomiting or retching, if so, the frequency, and the answers are "0" no, "1" once, "2" twice, "3" three or more times and have four choices. In the second question, it is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are "0" not much, "1" sometimes, "2" often or often, "3" always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines "clinically significant nausea and vomiting".
Postoperative Nausea and Vomiting
Simplified postoperative nausea and vomiting impact scale Developed by Myles and Wengritzky in 2012 and consisting of two questions, there are four options for each question that can be scored 0, 1, 2, 3 points. The first question asks whether there is vomiting or retching, if so, the frequency, and the answers are "0" no, "1" once, "2" twice, "3" three or more times and have four choices. In the second question, it is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are "0" not much, "1" sometimes, "2" often or often, "3" always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines "clinically significant nausea and vomiting".

Secondary Outcome Measures

Participant's satisfaction with the nursing care with
Numerical Rating scale consisting of numbers between "0" and "10" (0: not at all satisfied 10: very satisfied) have been used to determine the satisfaction level of patients at the 24th postoperative hour.

Full Information

First Posted
January 12, 2022
Last Updated
September 14, 2023
Sponsor
Sibel Yilmaz Sahin
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1. Study Identification

Unique Protocol Identification Number
NCT06048952
Brief Title
The Effect of Music Therapy After Bariatric Surgery on Postoperative Nausea Vomiting and Patient Satisfaction
Acronym
BSMusicPONV
Official Title
Bariatrik Cerrahi Sonrası Müzik Terapinin Postoperatif Bulantı Kusmayı Azaltma ve Hasta Memnuniyeti Üzerine Etkisi
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 2, 2021 (Actual)
Primary Completion Date
October 14, 2021 (Actual)
Study Completion Date
October 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sibel Yilmaz Sahin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, it was planned to evaluate the effectiveness of the use of music therapy, which is a non-pharmacological method, in addition to pharmacological treatment in patients with PONV after bariatric surgery, whose application frequency is increasing in the treatment of obesity, and to determine its effect on patient satisfaction. The findings of this study are considered to be effective in preventing nausea and vomiting, providing patient comfort, increasing evidence-based nursing knowledge and increasing the quality of care.
Detailed Description
Postoperative nausea and vomiting (POBK) according to ASPAN (American Society of PeriAnesthesia Nurses) are Nausea and vomiting seen in the first 24 hours after surgery (1). While PONV is seen in 20-30% of patients after general anesthesia, this rate increases up to 80% in high-risk patients (2). PONV, which is the second most common postoperative complaint after pain, is a stressful and uncomfortable situation for patients, but it can cause serious complications. These complications are; dehydration, electrolyte imbalance, acid-base imbalance, pulmonary aspiration, pneumothorax, hypoxia, esophageal rupture, increased intracranial pressure, suture rupture, bleeding (3). Due to the long duration of general anesthesia and the use of high-dose opioids, the incidence of PONV is higher in some types of surgery (eg, abdominal surgeries) (4). Recent studies have shown that laparoscopic, gynecological and cholecystectomy surgeries are high-risk surgeries in terms of PONV (5). While obesity ranks second among the preventable causes of death in the world, bariatric surgery is seen as the most effective method in the treatment of morbid obesity (6). Bariatric surgeries are surgeries that carry a high risk in terms of PONC, since they are abdominal surgery, performed under general anesthesia, and the laparoscopic method is preferred. Antiemetics can be used in high-risk patients after risk factors are determined to prevent PONV. However, due to complications, the effectiveness of the use of antiemetic drugs in the management of PONC remains limited (7). Published guidelines on PONC management recommend the use of non-pharmacological methods in addition to pharmacological treatment in patients at high risk for PONV. Some of the complementary methods used to prevent PONV are acupuncture, aromatherapy, acupressure, progressive relaxation exercises, hypnosis, massage, and music therapy (7). It has been reported in the literature that music therapy is a non-pharmacological nursing practice that is used to manage nausea-vomiting and the severity of symptoms, has no side effects, is easy to use (8). In addition, it has been noted that music therapy has positive effects on analgesic requirement, hospital stay, reducing fatigue and the use of antiemetic drugs (8). Çetinkaya's study to determine the effect of music on the severity of postoperative nausea and vomiting after laparoscopic cholecystectomy showed that listening to music reduces the severity of nausea and the frequency of nausea (9). According to a randomized controlled study conducted by Madson and Silverman in a group of 58 solid organ transplant patients, less nausea and vomiting were found in the music therapy group (10). In a study conducted by Nilsson et al. on hysterectomy patients who underwent general anesthesia in the intraoperative period, it was observed that music did not affect nausea and vomiting (11). In another study by Laurion and Fetzer, it was reported that music had no effect on PONV (12). In the fourth consensus guideline on the treatment of postoperative nausea and vomiting, it has been reported that music is not an effective prophylactic method for PONV, but this information is based on a single randomized controlled study (12,13). When the literature is examined, it has been determined that there is no common view on the use of music therapy as a complementary method in the management of PONV and more studies should be done on this subject. Aspan's evidence-based clinical practice guideline for the prevention and/or management of PONV/PDNV. J PeriAnesthesia Nurs. 2006, 21:230-250. Amirshahi M, Behnamfar N, Badakhsh M, Rafiemanesh H, Keikhaie KR, Sheyback M, Sari M. Prevalence of postoperative nausea and vomiting: A systematic review and meta-analysis. Saudi J Anaesth. 2020, 14:48-56 Lazo O., Paul F., R. Yumul, Cruz H Management strategies for the treatment and prevention of postoperative/postdischarge nausea and vomiting: an updated review. F1000Research, (2020)(Faculty Rev):983 Apfel CC, Heidrich FM, Jukar-Rao S, et al. Evidence-based analysis of risk factors for postoperative nausea and vomiting. Br J Anaesth 2012; 109: 742-53. Abd Elrazek AEMA, Elbanna AEM, Bilasy SE. Medical management of patients after bariatric surgery: Principles and guidelines. World J Gastrointest Surg 2014;6(11): 220-228. Güven B., Bariatrik Cerrahi Komplikasyonları ve Hemşirelik Bakımı, Hemşirelikte Eğitim Ve Araştırma Dergisi, 2019;16 (2): 139-143 H. Shabandokht-Zarmi, M. Bagheri-Nesami, S. Afshin Shorofi, S. Nouraddin Mousavinasab The effect of self-selected soothing music on fistula puncture-related pain in hemodialysis patients Complement. Ther. Clin. Pract., 29 (2017), pp. 53-57 S. Nicolete , JG Tong , J. Nicholas , U. Alberto , P. Jyoti , D. Rohan , DB Sergio Alternative therapies for the prevention of postoperative nausea and vomiting Front. Med. , 2 ( 2015 ) Çetinkaya F. The effects of listening to music on the postoperative nausea and vomiting. Complementary Therapies in Clinical Practice 35 (2019) 278-283 Madson AT, Silverman MJ. The effect of music therapy on relaxation, anxiety, pain perception, and nausea in adult solid organ transplant patients. J Music Ther 2010;47(3):220-32 U. Nilsson, N. Rawal, L.E. Uneståhl, C. Zetterberg, M. Unosson. Improved recovery after music and therapeutic suggestions during general anaesthesia: a double-blind randomised controlled trial Acta Anaesthesiol. Scand., 45 (2001), pp. 812-817 S. Laurion, S.J. Fetzer The effect of two nursing interventions on the postoperative outcomes of gynecologic laparoscopic patients J Perianesth Nurs, 18 (2003), pp. 226-254 Fourth Consensus Guidelines for the Management of Postoperative Nausea and Vomiting, Anesth Analg. (2020) Aug;131(2):411-448.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery
Keywords
bariatric surgery, music therapy, nausea and vomiting, postoperative, nursing care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention and Non Intervention Group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy
Arm Type
Active Comparator
Arm Description
30 Minutes before evaluate PONV at 2nd,4th,6th,12th,24th hours
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
No intervention performed PONV evaluated at 2nd,4th,6th,12th,24th hours
Intervention Type
Behavioral
Intervention Name(s)
Music Therapy
Intervention Description
Huseyni maqam, Pentatonic music
Primary Outcome Measure Information:
Title
Postoperative Nausea and Vomiting
Description
Simplified postoperative nausea and vomiting impact scale Developed by Myles and Wengritzky in 2012 and consisting of two questions, there are four options for each question that can be scored 0, 1, 2, 3 points. The first question asks whether there is vomiting or retching, if so, the frequency, and the answers are "0" no, "1" once, "2" twice, "3" three or more times and have four choices. In the second question, it is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are "0" not much, "1" sometimes, "2" often or often, "3" always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines "clinically significant nausea and vomiting".
Time Frame
Postoperative 2nd hour
Title
Postoperative Nausea and Vomiting
Description
Simplified postoperative nausea and vomiting impact scale Developed by Myles and Wengritzky in 2012 and consisting of two questions, there are four options for each question that can be scored 0, 1, 2, 3 points. The first question asks whether there is vomiting or retching, if so, the frequency, and the answers are "0" no, "1" once, "2" twice, "3" three or more times and have four choices. In the second question, it is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are "0" not much, "1" sometimes, "2" often or often, "3" always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines "clinically significant nausea and vomiting".
Time Frame
Postoperative 4th hour
Title
Postoperative Nausea and Vomiting
Description
Simplified postoperative nausea and vomiting impact scale Developed by Myles and Wengritzky in 2012 and consisting of two questions, there are four options for each question that can be scored 0, 1, 2, 3 points. The first question asks whether there is vomiting or retching, if so, the frequency, and the answers are "0" no, "1" once, "2" twice, "3" three or more times and have four choices. In the second question, it is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are "0" not much, "1" sometimes, "2" often or often, "3" always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines "clinically significant nausea and vomiting".
Time Frame
Postoperative 6th hour
Title
Postoperative Nausea and Vomiting
Description
Simplified postoperative nausea and vomiting impact scale Developed by Myles and Wengritzky in 2012 and consisting of two questions, there are four options for each question that can be scored 0, 1, 2, 3 points. The first question asks whether there is vomiting or retching, if so, the frequency, and the answers are "0" no, "1" once, "2" twice, "3" three or more times and have four choices. In the second question, it is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are "0" not much, "1" sometimes, "2" often or often, "3" always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines "clinically significant nausea and vomiting".
Time Frame
Postoperative 12th hour
Title
Postoperative Nausea and Vomiting
Description
Simplified postoperative nausea and vomiting impact scale Developed by Myles and Wengritzky in 2012 and consisting of two questions, there are four options for each question that can be scored 0, 1, 2, 3 points. The first question asks whether there is vomiting or retching, if so, the frequency, and the answers are "0" no, "1" once, "2" twice, "3" three or more times and have four choices. In the second question, it is questioned whether there is nausea (feeling of discomfort in the stomach and feeling like vomiting), whether the feeling of nausea, if any, affects your daily life activities such as getting out of bed, moving comfortably in bed, walking normally, or eating and drinking; The answers are "0" not much, "1" sometimes, "2" often or often, "3" always. The numerical value of the answers given to the first and second questions is added and the result is found. A score of five or more on the scale defines "clinically significant nausea and vomiting".
Time Frame
Postoperative 24th hour
Secondary Outcome Measure Information:
Title
Participant's satisfaction with the nursing care with
Description
Numerical Rating scale consisting of numbers between "0" and "10" (0: not at all satisfied 10: very satisfied) have been used to determine the satisfaction level of patients at the 24th postoperative hour.
Time Frame
Postoperative 24th hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Cognitive functions are sufficient, Able to communicate in Turkish, Between the ages of 18-80, Patients who voluntarily participated in the study Exclusion Criteria: Patients who did not volunteer for the study, Patients who underwent open surgery whose mother tongue is not Turkish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sibel YILMAZ SAHIN, Asst.Prof.
Organizational Affiliation
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Health Sciences
City
Ankara
ZIP/Postal Code
06010
Country
Turkey

12. IPD Sharing Statement

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The Effect of Music Therapy After Bariatric Surgery on Postoperative Nausea Vomiting and Patient Satisfaction

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