- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06820788
Effect of Music on Pain and Comfort Levels After Laparoscopic Abdominal Surgery
Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bitlis, Turkey (Türkiye), 13100
- Bitlis Eren University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
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.
|
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.
|
|
No Intervention: Control Group
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain level
Time Frame: 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.
|
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
Time Frame: 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.
|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Şerafettin OKUTAN, Dr., Bitlis Eren University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Postoperative Complications
- Pathologic Processes
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Pain
- Pain, Postoperative
- Therapeutics
- Complementary Therapies
- Patient Care
- Psychotherapy
- Behavioral Disciplines and Activities
- Rehabilitation
- Aftercare
- Continuity of Patient Care
- Sensory Art Therapies
- Music Therapy
Other Study ID Numbers
- okutan6
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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