NCT06048952

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

January 12, 2022

Last Update Submit

December 11, 2023

Conditions

Keywords

bariatric surgerymusic therapynausea and vomiting, postoperativenursing care

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 COMPARATOR

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

Behavioral: Music Therapy

No Intervention

NO INTERVENTION

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

Interventions

Music TherapyBEHAVIORAL

Huseyni maqam, Pentatonic music

Music Therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Sibel YILMAZ SAHIN, Asst.Prof.

    Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Intervention and Non Intervention Group
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

Locations