Clinical trial NCT06997237: The Effect of Music Played to Liver Transplant Donors During Surgery on Some Hemodynamic Values and Cortisol Levels
Official title: The Effect of Music Played to Liver Transplant Donors During Surgery on Hemodynamic Parameters and Cortisol Levels: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Stress Response
Keywords: Music Therapy
Cortisol
Hemodynamic Parameters
Liver Transplantation
Intraoperative Stress
Lead sponsor: Siirt University
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study employed a parallel assignment interventional model. Participants were randomly divided into three groups: (1) the music group, which received classical music intervention during surgery, (2) the silence group, which used noise-canceling headphones without music, and (3) the control group, which received no intervention. All participants were liver transplant donors. The hemodynamic values and cortisol levels of participants were measured and compared before, during, and after surgery to evaluate the physiological effects of music exposure.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized controlled trial investigates the effects of music played during liver donor surgery on hemodynamic parameters and cortisol levels. Ninety participants were divided into three groups: music, silence (with headphones but no sound), and a control group with no intervention. The study aimed to evaluate whether music can reduce stress-related physiological responses during surgery.

Detailed description: This study was designed to evaluate the effects of music played during surgery on liver transplant donors. The research included 90 adult participants who underwent live liver donation surgeries. Participants were randomly assigned to one of three groups: music group (headphones with music), silence group (headphones without sound), and a control group (no headphones). Music intervention lasted for 30 minutes during the operation.

The primary objective was to examine whether intraoperative music exposure could reduce physiological stress, measured via cortisol levels. Secondary outcomes included changes in hemodynamic parameters such as systolic and diastolic blood pressure, pulse rate, oxygen saturation, and respiratory rate. Measurements were taken before and after the surgery.

The study was conducted at İnönü University Liver Transplant Institute, with ethical approval granted by the Malatya Clinical Research Ethics Committee (Approval No: 2021/52). The findings suggest that music may be an effective supportive intervention for reducing surgical stress.

Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 65 years

Undergoing elective surgery as a liver donor

No physical or mental condition preventing listening to music

Willing to participate voluntarily and signing the informed consent form

Exclusion Criteria:

* Development of hemodynamic instability during anesthesia induction

Participants for whom the study could not be continued due to technical reasons during surgery

Participants who did not comply with the study protocol or had incomplete records

Primary outcomes:
measure: Change in Serum Cortisol Levels During the Intraoperative Period
timeFrame: Intraoperative (from pre-induction to the 30th minute of surgery)
Secondary outcomes:
measure: Change in Systolic Blood Pressure During the Intraoperative Period
timeFrame: Intraoperative (from pre-induction to the 30th minute of surgery)
measure: Change in Diastolic Blood Pressure During the Intraoperative Period
timeFrame: Intraoperative (from pre-induction to the 30th minute of surgery)
measure: Change in Heart Rate During the Intraoperative Period
timeFrame: Intraoperative (from pre-induction to the 30th minute of surgery),
measure: Change in Respiratory Rate During the Intraoperative Period
timeFrame: Intraoperative (from pre-induction to the 30th minute of surgery)
measure: Change in Peripheral Oxygen Saturation (SpO₂) During the Intraoperative Period
timeFrame: Intraoperative (from pre-induction to the 30th minute of surgery)
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Turgut Özal Medical Center, Liver Transplantation Institute
Study officials:
affiliation: Inonu University Faculty of Nursing
name: Meral ÖZKAN, Prof. Dr.
role: STUDY_CHAIR
References: