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NCT Number: NCT06997237

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

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.

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Key information

Conditions

Surgical Stress Response

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Turgut Özal Medical Center, Liver Transplantation Institute

Malatya, 44280, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Serum Cortisol Levels During the Intraoperative Period

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

    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.

Secondary outcomes

  1. Change in Systolic Blood Pressure During the Intraoperative Period

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

    Systolic blood pressure was measured at two intraoperative time points: (1) immediately before anesthesia induction and (2) at the 30th minute of surgery. The difference between the two values was used to assess the hemodynamic effect of music and silence interventions compared to standard care.

  2. Change in Diastolic Blood Pressure During the Intraoperative Period

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

    Diastolic blood pressure was measured at two intraoperative time points: (1) immediately before anesthesia induction and (2) at the 30th minute of surgery. Blood pressure was monitored continuously using a non-invasive automated device. The difference between the two values was analyzed to assess the effects of music and silence interventions on intraoperative hemodynamic response.

  3. Change in Heart Rate During the Intraoperative Period

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

    Heart rate was recorded at two intraoperative time points: (1) immediately before anesthesia induction and (2) at the 30th minute of surgery. Monitoring was performed using standard intraoperative ECG. The difference between the two values was analyzed to evaluate the effect of music and silence interventions on autonomic cardiac response during surgery.

  4. Change in Respiratory Rate During the Intraoperative Period

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

    Respiratory rate was recorded at two intraoperative time points: (1) immediately before anesthesia induction and (2) at the 30th minute of surgery. Monitoring was conducted using standard intraoperative vital sign monitoring systems. The difference between the two values was analyzed to evaluate the effect of music and silence interventions on respiratory function.

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

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

    Peripheral oxygen saturation (SpO₂) was measured at two intraoperative time points: (1) immediately before anesthesia induction and (2) at the 30th minute of surgery. Measurements were taken using standard pulse oximetry. The difference between the two values was used to assess the impact of music and silence interventions on tissue oxygenation during surgery.

Sponsors and collaborators

Lead sponsor

Hasan SARITAŞ

Other

Registry information

Official study title

The Effect of Music Played to Liver Transplant Donors During Surgery on Hemodynamic Parameters and Cortisol Levels: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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