Surgical Stress ResponseNCT06997237
The Effect of Music Played to Liver Transplant Donors During Surgery on Some Hemodynamic Values and Cortisol Levels
A study testing Music Listening Intervention and Silence with Headphones in people with Surgical Stress Response, run by Hasan SARITAŞ at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Surgical Stress Response
- What is being tested?
- Music Listening Intervention and Silence with Headphones
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2020to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Turgut Özal Medical Center, Liver Transplantation Institute
Malatya, Malatya, 44280
About this study
Official title: The Effect of Music Played to Liver Transplant Donors During Surgery on Hemodynamic Parameters and Cortisol Levels: A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Surgical Stress Response
- Being tested
- Music Listening Intervention, Silence with Headphones
- Keywords
- Music Therapy, Cortisol, Hemodynamic Parameters, Liver Transplantation, Intraoperative Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Listening InterventionBehavioural
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 HeadphonesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intraoperative (from pre-induction to the 30th minute of surgery)
Secondary outcomes (5)
Change in Systolic Blood Pressure During the Intraoperative Period
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.
Measured: Intraoperative (from pre-induction to the 30th minute of surgery)
Change in Diastolic Blood Pressure During the Intraoperative Period
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.
Measured: Intraoperative (from pre-induction to the 30th minute of surgery)
Change in Heart Rate During the Intraoperative Period
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.
Measured: Intraoperative (from pre-induction to the 30th minute of surgery),
Change in Respiratory Rate During the Intraoperative Period
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.
Measured: Intraoperative (from pre-induction to the 30th minute of surgery)
Change in Peripheral Oxygen Saturation (SpO₂) During the Intraoperative Period
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.
Measured: Intraoperative (from pre-induction to the 30th minute of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Dec 2020
- Primary completion1 Nov 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Stress ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan SARITAŞ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hasan SARITAŞ, Siirt University
- Investigators
- Meral ÖZKAN, Prof. Dr., Study chair, Inonu University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997237
- Sponsor's protocol ID
- SARITAS-MUSIC01
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because this study did not include a plan for data sharing in the ethical approval and informed consent process. Participant confidentiality and data protection are prioritized.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music Played to Liver Transplant Donors During Surgery on Hemodynamic Parameters and Cortisol Levels: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06997237
- Acronym / sponsor ID
- SARITAS-MUSIC01
- Conditions
- Surgical Stress Response
- Keywords
- Music Therapy, Cortisol, Hemodynamic Parameters, Liver Transplantation, Intraoperative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hasan SARITAŞUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Music Group | Experimental | Behavioral: Music Listening InterventionParticipants 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. |
| Silence Group | Sham comparator | Behavioral: Silence with HeadphonesParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music Listening InterventionParticipants 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. | Behavioural | Music Group |
| Silence with HeadphonesParticipants 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. | Behavioural | Silence Group |
Primary outcome
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.
5 secondary outcomes
Change in Systolic Blood Pressure During the Intraoperative Period
Time frame: Intraoperative (from pre-induction to the 30th minute of surgery)
Change in Diastolic Blood Pressure During the Intraoperative Period
Time frame: Intraoperative (from pre-induction to the 30th minute of surgery)
Change in Heart Rate During the Intraoperative Period
Time frame: Intraoperative (from pre-induction to the 30th minute of surgery),
Change in Respiratory Rate During the Intraoperative Period
Time frame: Intraoperative (from pre-induction to the 30th minute of surgery)
Change in Peripheral Oxygen Saturation (SpO₂) During the Intraoperative Period
Time frame: Intraoperative (from pre-induction to the 30th minute of surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because this study did not include a plan for data sharing in the ethical approval and informed consent process. Participant confidentiality and data protection are prioritized.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meral ÖZKAN, Prof. Dr. study chair
Inonu University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music Listening Intervention and Silence with Headphones in people with Surgical Stress Response, run by Hasan SARITAŞ at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Cortisol Levels During the Intraoperative Period (time frame: Intraoperative (from pre-induction to the 30th minute of surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.