TransplantationNCT06166186
Effect of Intraoperative Music on Inflammatory Response in Donor Hepatectomy
A study testing music and no music in people with Transplantation and Hepatectomy, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
It has been reported that non-pharmacological methods can be used as an alternative in addition to pharmacological methods to reduce pain, anxiety, stress and inflammatory response that begins with the surgical incision in the intraoperative period and continues throughout the operation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Transplantation, Hepatectomy, Music
- What is being tested?
- music and no music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 May 2023to 9 Sep 2024
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing donor hepatectomy
- American Society of Anesthesiologists class 1 to 2
- Ability to consent
Who cannot join
- American Society of Anesthesiologists greater than 2
- Documented or known sensitivity to any drug to be used in the study.
- Patient with immunosuppressant/ cytotoxic/ steroid therapy.
- not understand the aim and objectives of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intraoperative Music on Inflammatory Response in Adult Living Donor Hepatectomy.
It has been reported that non-pharmacological methods can be used as an alternative in addition to pharmacological methods to reduce pain, anxiety, stress and inflammatory response that begins with the surgical incision in the intraoperative period and continues throughout the operation. It has been reported that music can be used as an alternative non-pharmacological method to reduce pain and anxiety in the perioperative period, as well as surgical stress and the related stress response.
The aim of this study is to test the hypothesis that music used as a non-pharmacological method in the intraoperative period can reduce inflammatory response in living donor hepatectomy.
- Conditions
- Transplantation, Hepatectomy, Music, Stress Response
- Being tested
- music, no music
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
musicOther
A music with a standard volume will be delivered to the patients via headphones from the beginning of anesthesia induction to extubation.
no musicOther
Headphones will be applied to the patients but no music will be played from the beginning of anesthesia induction to extubation.
| Study group | Role | What they receive |
|---|---|---|
| Music Group | Active comparator | Music will be delivered via headphones intraoperatively. Blood samples will be collected as per the protocol. Receives: Other: music |
| Control Group | Active comparator | Headphones will be applied but no music will be played intraoperatively. Blood samples will be collected as per the protocol. Receives: Other: no music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Interleukin-6 (IL-6)
Serum levels of IL-6 will be measured preoperatively and postoperatively.
Measured: 4 hours
Secondary outcomes (10)
Difference in tumor necrosis factor alpha (TNF-alfa)
Serum levels of TNF-alpha will be measured preoperatively and postoperatively.
Measured: 4 hours
Difference between serum levels of total antioxidant capacity (TAC) at preoperative and postoperative period.
Blood samples will be collected preoperatively and postoperatively to measure serum levels of TAC. Blood samples will be stored in medical refrigerator and analysis for serum levels of TAC will be done after collection of all samples.
Measured: 4 hours
Difference between serum levels of total oxidant capacity (TOC) at preoperative and postoperative period.
Blood samples will be collected preoperatively and postoperatively to measure serum levels of TOC. Blood samples will be stored in medical refrigerator and analysis for serum levels of TOC will be done after collection of all samples.
Measured: 4 hours
Difference in c-reactive protein (CRP)
Serum levels of CRP will be measured preoperatively and postoperatively.
Measured: 24 hours
Difference in alanine aminotransferase (ALT)
Serum levels of ALT will be measured preoperatively and postoperatively.
Measured: 24 hours
Difference in aspartate aminotransferase (AST)
Serum levels of AST will be measured preoperatively and postoperatively.
Measured: 24 hours
Difference in creatinine
Serum levels of creatinine will be measured preoperatively and postoperatively.
Measured: 24 hours
Differences in preoperative State-Trait Anxiety Inventory scores
assessed 1 day before surgery. The total score on the scale ranges from 20 to 80 points and a higher score represents greater anxiety.
Measured: 20 minutes
Differences in postoperative State-Trait Anxiety Inventory scores
assessed 1st day after surgery. The total score on the scale ranges from 20 to 80 points and a higher score represents greater anxiety.
Measured: 20 minutes
Differences in pain scores
Assessed 1st, 6th, 12th and 24th hour postoperatively. (from 0 (no pain) to 10 (maximal possible pain))
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start22 May 2023
- Primary completion12 Jul 2024
- Study completion9 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransplantationStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor
- Investigators
- Beyza Zeynep Kocabicak, Principal investigator, Istinye UniversityAli Sait Kavakli, M.D., Principal investigator, Istinye UniversityTaylan Sahin, M.D., Principal investigator, İstinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166186
- Sponsor's protocol ID
- anestezi3
- Status last verified
- Oct 2023
- First submitted
- 14 Nov 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative Music on Inflammatory Response in Adult Living Donor Hepatectomy.
- ClinicalTrials.gov ID
- NCT06166186
- Acronym / sponsor ID
- anestezi3
- Conditions
- Transplantation, Hepatectomy, Music, Stress Response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 22 May 2023 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 9 Sep 2024 (actual)
- First posted
- 12 Dec 2023 (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 has been reported that non-pharmacological methods can be used as an alternative in addition to pharmacological methods to reduce pain, anxiety, stress and inflammatory response that begins with the surgical incision in the intraoperative period and continues throughout the operation. It has been reported that music can be used as an alternative non-pharmacological method to reduce pain and anxiety in the perioperative period, as well as surgical stress and the related stress response.
The aim of this study is to test the hypothesis that music used as a non-pharmacological method in the intraoperative period can reduce inflammatory response in living donor hepatectomy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music Group | Active comparator | Other: musicMusic will be delivered via headphones intraoperatively. Blood samples will be collected as per the protocol. |
| Control Group | Active comparator | Other: no musicHeadphones will be applied but no music will be played intraoperatively. Blood samples will be collected as per the protocol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing donor hepatectomy
- American Society of Anesthesiologists class 1 to 2
- Ability to consent
Key exclusion criteria (4 listed)
- American Society of Anesthesiologists greater than 2
- Documented or known sensitivity to any drug to be used in the study.
- Patient with immunosuppressant/ cytotoxic/ steroid therapy.
- not understand the aim and objectives of the study
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 |
|---|---|---|
| musicA music with a standard volume will be delivered to the patients via headphones from the beginning of anesthesia induction to extubation. | Other | Music Group |
| no musicHeadphones will be applied to the patients but no music will be played from the beginning of anesthesia induction to extubation. | Other | Control Group |
Primary outcome
Differences in Interleukin-6 (IL-6)
Time frame: 4 hours
Serum levels of IL-6 will be measured preoperatively and postoperatively.
10 secondary outcomes
Difference in tumor necrosis factor alpha (TNF-alfa)
Time frame: 4 hours
Difference between serum levels of total antioxidant capacity (TAC) at preoperative and postoperative period.
Time frame: 4 hours
Difference between serum levels of total oxidant capacity (TOC) at preoperative and postoperative period.
Time frame: 4 hours
Difference in c-reactive protein (CRP)
Time frame: 24 hours
Difference in alanine aminotransferase (ALT)
Time frame: 24 hours
Difference in aspartate aminotransferase (AST)
Time frame: 24 hours
Difference in creatinine
Time frame: 24 hours
Differences in preoperative State-Trait Anxiety Inventory scores
Time frame: 20 minutes
Differences in postoperative State-Trait Anxiety Inventory scores
Time frame: 20 minutes
Differences in pain scores
Time frame: 24 hours
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 22 Sep 2025.
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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.
Beyza Zeynep Kocabicak principal investigator
Istinye University
Ali Sait Kavakli, M.D. principal investigator
Istinye University
Taylan Sahin, M.D. principal investigator
İstinye 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 and no music in people with Transplantation and Hepatectomy, run by Istinye 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 3 inclusion and 4 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 22 Sep 2025. 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?
Differences in Interleukin-6 (IL-6) (time frame: 4 hours). 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 22 Sep 2025.