Effect of Intraoperative Music on Inflammatory Response in Donor Hepatectomy

September 17, 2025 updated by: Istinye University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients undergoing donor hepatectomy
  • American Society of Anesthesiologists class 1 to 2
  • Ability to consent

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Music Group
Music will be delivered via headphones intraoperatively. Blood samples will be collected as per the protocol.
Other: music
A music with a standard volume will be delivered to the patients via headphones from the beginning of anesthesia induction to extubation.
Active Comparator: Control Group
Headphones will be applied but no music will be played intraoperatively. Blood samples will be collected as per the protocol.
Other: no music
Headphones will be applied to the patients but no music will be played from the beginning of anesthesia induction to extubation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in Interleukin-6 (IL-6)
Time Frame: 4 hours
Serum levels of IL-6 will be measured preoperatively and postoperatively.
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in preoperative State-Trait Anxiety Inventory scores
Time Frame: 20 minutes
assessed 1 day before surgery. The total score on the scale ranges from 20 to 80 points and a higher score represents greater anxiety.
20 minutes
Differences in postoperative State-Trait Anxiety Inventory scores
Time Frame: 20 minutes
assessed 1st day after surgery. The total score on the scale ranges from 20 to 80 points and a higher score represents greater anxiety.
20 minutes
Difference in tumor necrosis factor alpha (TNF-alfa)
Time Frame: 4 hours
Serum levels of TNF-alpha will be measured preoperatively and postoperatively.
4 hours
Difference between serum levels of total antioxidant capacity (TAC) at preoperative and postoperative period.
Time Frame: 4 hours
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.
4 hours
Difference between serum levels of total oxidant capacity (TOC) at preoperative and postoperative period.
Time Frame: 4 hours
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.
4 hours
Difference in c-reactive protein (CRP)
Time Frame: 24 hours
Serum levels of CRP will be measured preoperatively and postoperatively.
24 hours
Difference in alanine aminotransferase (ALT)
Time Frame: 24 hours
Serum levels of ALT will be measured preoperatively and postoperatively.
24 hours
Difference in aspartate aminotransferase (AST)
Time Frame: 24 hours
Serum levels of AST will be measured preoperatively and postoperatively.
24 hours
Difference in creatinine
Time Frame: 24 hours
Serum levels of creatinine will be measured preoperatively and postoperatively.
24 hours
Differences in pain scores
Time Frame: 24 hours
Assessed 1st, 6th, 12th and 24th hour postoperatively. (from 0 (no pain) to 10 (maximal possible pain))
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istinye University

Collaborators

The Scientific and Technological Research Council of Turkey

Investigators

  • Principal Investigator: Ali Sait Kavakli, M.D., Istinye University
  • Principal Investigator: Taylan Sahin, M.D., Istinye University
  • Principal Investigator: Beyza Zeynep Kocabicak, Istinye University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2023

Primary Completion (Actual)

July 12, 2024

Study Completion (Actual)

September 9, 2024

Study Registration Dates

First Submitted

November 14, 2023

First Submitted That Met QC Criteria

December 8, 2023

First Posted (Actual)

December 12, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 17, 2025

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • anestezi3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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