Clinical trial NCT06820788: Effect of Music on Pain and Comfort Levels After Laparoscopic Abdominal Surgery
Official title: Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Surgery
Keywords: music therapy
pain
laparoscopic surgery
comfort
Lead sponsor: Bitlis Eren University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: It will be conducted as a randomized controlled experimental study in a pre-testpost-test control group experimental model.
Primary purpose: OTHER

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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: pain level
timeFrame: 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.
measure: comfort level
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Bitlis
country: Turkey
facility: Bitlis Eren University
Study officials:
affiliation: Bitlis Eren University
name: Şerafettin OKUTAN, Dr.
role: PRINCIPAL_INVESTIGATOR
References: