The Effect of Music Played to Liver Transplant Donors During Surgery on Some Hemodynamic Values and Cortisol Levels

NCT ID: NCT06997237

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-12-20

Brief Summary

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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

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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.

Conditions

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Surgical Stress Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Music Group

Participants in this group listened to a playlist composed of music pieces they selected prior to surgery, consisting of approximately 5-6 tracks. The music was played continuously for 30 minutes during the surgery through Bluetooth headphones. The sound level was set at 65 decibels.

Group Type EXPERIMENTAL

Music Listening Intervention

Intervention Type BEHAVIORAL

Participants listened to a playlist of 5-6 music tracks they personally selected before surgery. The music was played continuously for 30 minutes through Bluetooth headphones during liver transplantation. Volume was kept at 65 decibels.

Silence Group

Participants in this group wore headphones during the surgery, but no music was played. The headphones were used to block ambient operating room sounds. This group was used to control for the effect of wearing headphones without auditory stimulation.

Group Type SHAM_COMPARATOR

Silence with Headphones

Intervention Type BEHAVIORAL

Participants wore Bluetooth headphones during the surgery, but no audio was played. This intervention was designed to control for the effect of wearing headphones and isolating ambient operating room sounds.

Control Group

Participants in this group did not receive any intervention. No headphones were worn, and no music or auditory stimulus was provided during the surgery. This group served as the control to compare the effects of music and silence interventions.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Music Listening Intervention

Participants listened to a playlist of 5-6 music tracks they personally selected before surgery. The music was played continuously for 30 minutes through Bluetooth headphones during liver transplantation. Volume was kept at 65 decibels.

Intervention Type BEHAVIORAL

Silence with Headphones

Participants wore Bluetooth headphones during the surgery, but no audio was played. This intervention was designed to control for the effect of wearing headphones and isolating ambient operating room sounds.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hasan SARITAŞ

OTHER

Sponsor Role lead

Responsible Party

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Hasan SARITAŞ

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Meral ÖZKAN, Prof. Dr.

Role: STUDY_CHAIR

Inonu University Faculty of Nursing

Locations

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Turgut Özal Medical Center, Liver Transplantation Institute

Malatya, Malatya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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SARITAS-MUSIC01

Identifier Type: -

Identifier Source: org_study_id

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