Effect of Intraoperative Music on Inflammatory Response in Donor Hepatectomy

Not Applicable

Recruiting

• Conditions: Music; Stress Response; Hepatectomy; Transplantation
• Interventions: Other: no music; Other: music

• Registration Number: NCT06166186
• Lead Sponsor: Istinye University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-05-22
• Status Verified: 2023-10
• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-12-08
• Last Update Submitted: 2023-12-08
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12
• Primary Completion: 2024-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	no music	Headphones will be applied but no music will be played intraoperatively. Blood samples will be collected as per the protocol.
Music Group	music	Music will be delivered via headphones intraoperatively. Blood samples will be collected as per the protocol.

Primary Outcome Measures

Name	Time	Method
Differences in Interleukin-6 (IL-6)	4 hours	Serum levels of IL-6 will be measured preoperatively and postoperatively.

Secondary Outcome Measures

Name	Time	Method
Difference between serum levels of total antioxidant capacity (TAC) at preoperative and postoperative period.	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.
Difference in tumor necrosis factor alpha (TNF-alfa)	4 hours	Serum levels of TNF-alpha will be measured preoperatively and postoperatively.
Differences in preoperative State-Trait Anxiety Inventory scores	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.
Difference between serum levels of total oxidant capacity (TOC) at preoperative and postoperative period.	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.
Difference in c-reactive protein (CRP)	24 hours	Serum levels of CRP will be measured preoperatively and postoperatively.
Difference in alanine aminotransferase (ALT)	24 hours	Serum levels of ALT will be measured preoperatively and postoperatively.
Difference in creatinine	24 hours	Serum levels of creatinine will be measured preoperatively and postoperatively.
Differences in pain scores	24 hours	Assessed 1st, 6th, 12th and 24th hour postoperatively. (from 0 (no pain) to 10 (maximal possible pain))
Difference in aspartate aminotransferase (AST)	24 hours	Serum levels of AST will be measured preoperatively and postoperatively.
Differences in postoperative State-Trait Anxiety Inventory scores	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.

Trial Locations

Locations (1)

Istinye University Hospital; 🇹🇷 Istanbul, Turkey