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

NCT06997237 | Completed

• 1 other identifier: SARITAS-MUSIC01
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Stress Response

Keywords

Music Therapy; Cortisol; Hemodynamic Parameters; Liver Transplantation; Intraoperative Stress

Outcome Measures

Primary Outcomes (1)

• Change in Serum Cortisol Levels During the Intraoperative Period

  Serum cortisol levels were measured at two intraoperative time points: (1) immediately before anesthesia induction and (2) at the 30th minute of surgery. Blood samples were drawn from the radial artery, centrifuged, stored at -80°C, and later analyzed using the ELISA method. The difference between the two measurements was calculated to evaluate the physiological impact of the interventions.

  Intraoperative (from pre-induction to the 30th minute of surgery)

Secondary Outcomes (5)

• Change in Systolic Blood Pressure During the Intraoperative Period

  Intraoperative (from pre-induction to the 30th minute of surgery)

• Change in Diastolic Blood Pressure During the Intraoperative Period

  Intraoperative (from pre-induction to the 30th minute of surgery)

• Change in Heart Rate During the Intraoperative Period

  Intraoperative (from pre-induction to the 30th minute of surgery),

• Change in Respiratory Rate During the Intraoperative Period

  Intraoperative (from pre-induction to the 30th minute of surgery)

• Change in Peripheral Oxygen Saturation (SpO₂) During the Intraoperative Period

  Intraoperative (from pre-induction to the 30th minute of surgery)

Study Arms (3)

Music Group

EXPERIMENTAL

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.

Behavioral: Music Listening Intervention

Silence Group

SHAM COMPARATOR

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.

Behavioral: Silence with Headphones

Control Group

NO INTERVENTION

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.

Interventions

Music Listening Intervention 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.

Music Group

Silence with Headphones 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.

Silence Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasan SARITAŞ: lead

Study Sites (1)

Turgut Özal Medical Center, Liver Transplantation Institute

Malatya, Malatya, 44280, Turkey (Türkiye)

Location

Study Officials

• Meral ÖZKAN, Prof. Dr.

  Inonu University Faculty of Nursing

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 30, 2025
• Study Start: December 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: December 20, 2022
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)