NCT06820788

Brief Summary

It is planned to examine the effects of local music on pain and comfort levels in patients undergoing laparoscopic abdominal surgery and to make a comparison between Turkey and Iran with the results obtained. The hypotheses of the study are as follows: H1-0: Music has no effect on reducing pain in patients undergoing laparoscopic abdominal surgery. H1-1: Music has an effect on reducing pain in patients undergoing laparoscopic abdominal surgery. H2-0: Music has no effect on increasing comfort in patients undergoing laparoscopic abdominal surgery. H2-1: Music has an effect on increasing comfort in patients undergoing laparoscopic abdominal surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

February 6, 2025

Last Update Submit

January 26, 2026

Conditions

Keywords

music therapypainlaparoscopic surgerycomfort

Outcome Measures

Primary Outcomes (2)

  • pain level

    Numerical Rating Scale: This scale, which is intended to determine the severity of pain, aims to have the patient describe their pain with numbers. In the form, 0 points are evaluated as "no pain", 1-3 points as "mild pain", 4-6 points as "moderate pain", and 7 and above points as "severe pain"

    The patients will be given the scale in the patient room 2 hours after the surgery. The scale will be given again as a final test immediately after the music listening is over.

  • comfort level

    General Comfort Scale Short Form: General Comfort Scale Short Form is the Turkish adaptation of the General Comfort Scale developed by Kolcaba to measure the individual's comfort level in a more understandable way and in a shorter time. The scale consists of 28 items and the items of the scale are scored between 28-168. High scores indicate a high level of comfort.

    The patients will be given the scale in the patient room 2 hours after the surgery. The scale will be given again as a final test immediately after the music listening is over.

Study Arms (2)

Intervention Group

EXPERIMENTAL

As part of the pre-test, the patient introduction form, comfort and pain scales will be applied to the experimental group patients. Music will be played in the patient room 2 hours after the patients are transferred from the post-operative care unit to the clinic, which is the most appropriate time after surgery, when vital signs are stable and clinical compliance is achieved. Music will be played for 20 minutes. As part of the post-test, the comfort and pain scales will be applied to the experimental group patients again.

Other: music therapy

Control Group

NO INTERVENTION

As part of the pre-test, the patient introduction form, comfort and pain scales will be applied to the control group patients. No intervention will be applied to the control group patients and the clinic's routine practices will continue. As part of the post-test, the comfort and pain scales will be applied to the control group patients again.

Interventions

Local music will be played in the patient room 2 hours after the patient is transferred from the postoperative care unit to the clinic, which is the most appropriate time after surgery, when vital signs have stabilized and clinical adaptation has been achieved.

Intervention Group

Eligibility Criteria

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

You may qualify if:

  • Must be over 18 years old
  • Must not have communication problems

You may not qualify if:

  • Having any hearing or mental problems
  • Laparoscopic surgery converted to open surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bitlis Eren University

Bitlis, 13100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Şerafettin OKUTAN, Dr.

    Bitlis Eren University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: It will be conducted as a randomized controlled experimental study in a pre-testpost-test control group experimental model.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 11, 2025

Study Start

March 1, 2025

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations