The Effect of Music Therapy After Bariatric Surgery on Postoperative Nausea Vomiting and Patient Satisfaction
BSMusicPONV
Bariatrik Cerrahi Sonrası Müzik Terapinin Postoperatif Bulantı Kusmayı Azaltma ve Hasta Memnuniyeti Üzerine Etkisi
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2021
CompletedFirst Submitted
Initial submission to the registry
January 12, 2022
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedDecember 15, 2023
December 1, 2023
6 months
January 12, 2022
December 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Postoperative Nausea and Vomiting
Simplified postoperative nausea and vomiting impact scale 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 2nd hour
Postoperative Nausea and Vomiting
Simplified postoperative nausea and vomiting impact scale consisting of two questions, there are four options for each question that can be scored 0, 1, 2, or 3 points. The first question asks whether there is vomiting or retching, if so, the frequency and the answers are no, once, twice, three or more times and have four choices. In the second question, 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 not much, sometimes, often or often, 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 4th hour
Postoperative Nausea and Vomiting
Simplified postoperative nausea and vomiting impact scale consisting of two questions, there are four options for each question that can be scored 0, 1, 2, or 3 points. The first question asks whether there is vomiting or retching, if so, the frequency and the answers are no, once, twice, three or more times and have four choices. In the second question, 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 not much, sometimes, often or often, 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 6th hour
Postoperative Nausea and Vomiting
Simplified postoperative nausea and vomiting impact scale consisting of two questions, there are four options for each question that can be scored 0, 1, 2, or 3 points. The first question asks whether there is vomiting or retching, if so, the frequency and the answers are no, once, twice, three or more times and have four choices. In the second question, 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 not much, sometimes, often or often, 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 12th hour
Postoperative Nausea and Vomiting
Simplified postoperative nausea and vomiting impact scale consisting of two questions, there are four options for each question that can be scored 0, 1, 2, or 3 points. The first question asks whether there is vomiting or retching, if so, the frequency and the answers are no, once, twice, three or more times and have four choices. In the second question, 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 not much, sometimes, often or often, 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 24th hour
Secondary Outcomes (1)
Participant's satisfaction with the nursing care with
Postoperative 24th hour
Study Arms (2)
Music Therapy
ACTIVE COMPARATOR30 Minutes before evaluate PONV at 2nd,4th,6th,12th,24th hours
No Intervention
NO INTERVENTIONNo intervention performed PONV evaluated at 2nd,4th,6th,12th,24th hours
Interventions
Eligibility Criteria
You may qualify if:
- Cognitive functions are sufficient,
- Able to communicate in Turkish,
- Between the ages of 18-80,
- Patients who voluntarily participated in the study
You may not qualify if:
- Patients who did not volunteer for the study,
- Patients who underwent open surgery
- whose mother tongue is not Turkish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Health Sciences
Ankara, 06010, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sibel YILMAZ SAHIN, Asst.Prof.
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
January 12, 2022
First Posted
September 21, 2023
Study Start
May 2, 2021
Primary Completion
October 14, 2021
Study Completion
October 14, 2021
Last Updated
December 15, 2023
Record last verified: 2023-12