Effect of Intraoperative Music on Inflammatory Response in Donor Hepatectomy

NCT06166186 | Completed

• 1 other identifier: anestezi3
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Differences in Interleukin-6 (IL-6)

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

  4 hours

Secondary Outcomes (10)

• Difference in tumor necrosis factor alpha (TNF-alfa)

  4 hours

• Difference between serum levels of total antioxidant capacity (TAC) at preoperative and postoperative period.

  4 hours

• Difference between serum levels of total oxidant capacity (TOC) at preoperative and postoperative period.

  4 hours

• Difference in c-reactive protein (CRP)

  24 hours

• Difference in alanine aminotransferase (ALT)

  24 hours

Study Arms (2)

Music Group

ACTIVE COMPARATOR

Music will be delivered via headphones intraoperatively. Blood samples will be collected as per the protocol.

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.

Other: no music

Interventions

music OTHER

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

Music Group

no music OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istinye University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Istinye University Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fractures, Stress

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Sensory Art Therapies; Complementary Therapies; Therapeutics; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Beyza Zeynep Kocabicak

  Istinye University

  PRINCIPAL INVESTIGATOR

• Ali Sait Kavakli, M.D.

  Istinye University

  PRINCIPAL INVESTIGATOR

• Taylan Sahin, M.D.

  İstinye University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: December 12, 2023
• Study Start: May 22, 2023
• Primary Completion: July 12, 2024
• Study Completion: September 9, 2024
• Last Updated: September 22, 2025

Record last verified: 2023-10

Locations

TU (1)