Pain, PostoperativeNCT06820788
Effect of Music on Pain and Comfort Levels After Laparoscopic Abdominal Surgery
A study testing music therapy in people with Pain, Postoperative and Surgery, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Surgery
- What is being tested?
- music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be over 18 years old
- Must not have communication problems
Who cannot join
- Having any hearing or mental problems
- Laparoscopic surgery converted to open surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain, Postoperative, Surgery
- Being tested
- music therapy
- Keywords
- music therapy, pain, laparoscopic surgery, comfort
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Mar 2025
- Primary completion1 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- It will be conducted as a randomized controlled experimental study in a pre-testpost-test control group experimental model.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitlis Eren University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serafettin Okutan, Bitlis Eren University
- Investigators
- Şerafettin OKUTAN, Dr., Principal investigator, Bitlis Eren University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820788
- Sponsor's protocol ID
- okutan6
- Status last verified
- Jan 2026
- First submitted
- 6 Feb 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator, Assistant Professor Şerafettin OKUTAN, Surgical Nursing, Faculty of Health Sciences, Bitlis Eren University
- ClinicalTrials.gov ID
- NCT06820788
- Acronym / sponsor ID
- okutan6
- Conditions
- Pain, Postoperative, Surgery
- Keywords
- music therapy, pain, laparoscopic surgery, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bitlis Eren UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- It will be conducted as a randomized controlled experimental study in a pre-testpost-test control group experimental model.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: music therapyAs 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be over 18 years old
- Must not have communication problems
Key exclusion criteria (2 listed)
- Having any hearing or mental problems
- Laparoscopic surgery converted to open surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music therapyLocal 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. | Other | Intervention Group |
Primary outcome
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"
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Şerafettin OKUTAN, Dr. principal investigator
Bitlis Eren University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music therapy in people with Pain, Postoperative and Surgery, run by Bitlis Eren University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.