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Completed

NCT Number: NCT06166186

Effect of Intraoperative Music on Inflammatory Response in 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.

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Key information

Conditions

Transplantation Fractures, Bone Fractures, Stress Hepatectomy Music Stress Response Wounds and Injuries

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istinye University Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music

Other

A music with a standard volume will be delivered to the patients via headphones from the beginning of anesthesia induction to extubation.

no music

Other

Headphones will be applied to the patients but no music will be played from the beginning of anesthesia induction to extubation.

Primary outcomes

  1. Differences in Interleukin-6 (IL-6)

    Time frame: 4 hours

    Serum levels of IL-6 will be measured preoperatively and postoperatively.

Secondary outcomes

  1. Difference in tumor necrosis factor alpha (TNF-alfa)

    Time frame: 4 hours

    Serum levels of TNF-alpha will be measured preoperatively and postoperatively.

  2. 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.

  3. 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. Difference in c-reactive protein (CRP)

    Time frame: 24 hours

    Serum levels of CRP will be measured preoperatively and postoperatively.

  5. Difference in alanine aminotransferase (ALT)

    Time frame: 24 hours

    Serum levels of ALT will be measured preoperatively and postoperatively.

  6. Difference in aspartate aminotransferase (AST)

    Time frame: 24 hours

    Serum levels of AST will be measured preoperatively and postoperatively.

  7. Difference in creatinine

    Time frame: 24 hours

    Serum levels of creatinine will be measured preoperatively and postoperatively.

  8. 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.

  9. 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.

  10. 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))

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Effect of Intraoperative Music on Inflammatory Response in Adult Living Donor Hepatectomy.

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 12, 2023
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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