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Cardiac SurgeryGVM-CARDIONCT07379944

Guided Visualization Meditation for Reducing Surgical Stress Response in Cardiac Surgery Patients

A study testing Guided Visualization Meditation in people with Cardiac Surgery and Surgical Stress Response, run by University of Gaziantep at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate whether guided visualization meditation can reduce the surgical stress response in patients undergoing open-heart surgery. Surgical stress response includes changes in hormones, blood glucose, and anxiety levels that occur before and after major surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Guided Visualization Meditation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jan 2026to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults aged 18 years or older
  • Scheduled to undergo open-heart surgery
  • ASA physical status I-II
  • First-time cardiac surgery
  • On-pump, median sternotomy technique planned
  • Mild to moderate intraoperative hypothermia protocol
Show all 13Show fewer
  • No diagnosed psychiatric disorder
  • Not using psychotropic medications
  • No endocrine disorders affecting cortisol (e.g., Addison's disease, Cushing's syndrome)
  • Not taking corticosteroid medications
  • Glasgow Coma Score = 15 postoperatively
  • No perioperative complications that may interfere with participation
  • Able and willing to provide informed consent

Who cannot join

  • Prolonged or complicated surgery
  • Withdrawal of consent at any stage
  • Postoperative altered consciousness (GCS < 15)
  • Perioperative administration of corticosteroids
  • Severe intraoperative complications
  • Surgery cancelled or rescheduled
  • Hearing impairment preventing participation in auditory intervention
  • Any condition clinically judged by the investigator to interfere with study participation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

TUGBA ALBAYRAM, Dr. contact

+905548758383

tugbaalbayram@gmail.com

Tugba ALBAYRAM Study Coordinator / Sub-Investigator, Research Assistant Dr. contact

Turkey (Türkiye)1 site
  • Gaziantep University

    Gaziantep, Şehitkamil, 27310

    TUGBA ALBAYRAM, 05548758383, tugbaalbayram@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Guided Visualization Meditation on Surgical Stress Response in Patients Undergoing Cardiac Surgery: A Nonrandomized Controlled Clinical Trial

This study aims to evaluate whether guided visualization meditation can reduce the surgical stress response in patients undergoing open-heart surgery. Surgical stress response includes changes in hormones, blood glucose, and anxiety levels that occur before and after major surgery. Guided visualization meditation is a non-invasive relaxation technique that uses calming audio instructions to help patients imagine peaceful scenes and reduce stress.

In this study, patients scheduled for cardiac surgery will be assigned to one of two groups: an intervention group that receives guided visualization meditation and a control group that receives standard care only. Patients in the intervention group will listen to an audio recording containing guided visualization and calming background music through headphones. Sessions will be provided twice on the day before surgery, twice on the day of surgery, and twice on the first postoperative day.

Read more

To evaluate the effects of the intervention, blood samples will be collected to measure cortisol, glucose, and insulin levels. Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI-I and STAI-II), and pain will be measured using a visual pain scale. These measurements will be performed at three specific time points: one day before surgery, six hours after extubation, and one day post-surgery.

The goal of this research is to determine whether guided visualization meditation can help reduce stress-related physiological and psychological changes in patients undergoing cardiac surgery. If effective, this method may offer a simple, safe, and supportive strategy to improve recovery and overall patient well-being.

Read the detailed description

Major cardiac surgery triggers a strong neuroendocrine and psychological stress response, which can negatively affect postoperative recovery. The surgical stress response is primarily characterized by increased cortisol secretion, elevated blood glucose levels, insulin resistance, fluid retention, increased cardiac workload, and heightened anxiety. Excessive or prolonged stress response may contribute to complications, delayed healing, and extended intensive care or hospital stay. Reducing the magnitude of the surgical stress response is considered an important component of perioperative patient management.

Guided visualization meditation is a non-pharmacologic mind-body technique that uses structured verbal guidance, calming metaphors, and controlled breathing cues to help individuals focus attention on peaceful imagery. This technique may influence autonomic nervous system activity, reduce sympathetic arousal, and improve emotional regulation. Prior studies suggest that guided relaxation strategies can lead to reductions in cortisol, improvements in anxiety levels, and improved patient comfort. However, there is limited evidence regarding their effectiveness in patients undergoing open-heart surgery.

This study is designed as a non-randomized, controlled, interventional clinical trial with two parallel groups: an intervention group receiving guided visualization meditation and a control group receiving standard postoperative care. Each participant in the intervention group will listen to a 15-20 minute guided visualization audio recording with calming background music twice daily on three consecutive days: the day before surgery (T0), the day of surgery (T1), and the first postoperative day (T2). Audio will be delivered through headphones in a quiet clinical environment.

Primary outcomes will include serum cortisol levels measured at T0, T1 (six hours after extubation), and T2. Secondary outcomes will include serum glucose and insulin levels, State-Trait Anxiety Inventory scores (STAI-I and STAI-II), and pain scores assessed using a visual pain scale. All biochemical samples will be obtained by clinical staff following routine safety protocols. Anxiety and pain assessments will be completed face-to-face by trained research personnel.

Eligibility criteria include adults aged 18 or older scheduled for first-time on-pump cardiac surgery via median sternotomy, ASA I-II classification, mild to moderate hypothermia protocol, and the absence of psychiatric diagnoses or corticosteroid use. Patients experiencing complications, prolonged surgery, or altered postoperative consciousness will be excluded.

Data will be collected prospectively and analyzed using statistical software (SPSS). Descriptive statistics, normality testing, and appropriate comparative tests (ANOVA, repeated-measures analyses) will be applied to evaluate changes over time and differences between groups. The primary hypothesis is that guided visualization meditation will result in significantly lower cortisol levels and reduced anxiety compared to standard care.

This research aims to contribute to supportive care practices in cardiac surgery by evaluating a low-cost, non-invasive, and easily implementable intervention that may help regulate neuroendocrine stress responses and improve postoperative outcomes.

Being tested
Guided Visualization Meditation
Keywords
guided visualization, meditation, mind-body intervention, STAI, perioperative care, cardiac surgery patients, insulin resistance, blood glucose
Medical subject headings
Coronary Artery Disease, Anxiety Disorders, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guided Visualization MeditationBehavioural

    A 15-20 minute guided visualization audio session including verbal imagery and relaxation techniques. Delivered via headphones twice daily on the preoperative day, surgery day, and postoperative day 1.

Study groups in NCT07379944
Study groupRoleWhat they receive
Guided Visualization MeditationExperimentalA 15-20 minute guided visualization audio session including verbal imagery and relaxation techniques. Delivered via headphones twice daily on the preoperative day, surgery day, and postoperative day 1.
Receives: Behavioral: Guided Visualization Meditation
Standard CareNo interventionParticipants receive routine perioperative standard care without guided visualization meditation. All biometric and psychological measurements are collected at the same time points as the intervention group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Cortisol Level

    Serum cortisol levels will be measured at three perioperative time points to evaluate the neuroendocrine surgical stress response. A reduction in cortisol levels in the intervention group compared with the control group will indicate the effectiveness of guided visualization meditation.

    Measured: One day before surgery, six hours after extubation on the day of surgery, and one day after surgery

Secondary outcomes (5)
  1. Serum Glucose Level

    Serum glucose levels will be measured at three perioperative time points to assess

    Measured: One day before surgery, six hours after extubation on the day of surgery, and one day after surgery

  2. Serum Insulin Level

    Serum insulin levels will be measured to evaluate perioperative insulin resistance as part of the surgical stress response. Lower insulin levels in the intervention group compared with the control group will suggest improved metabolic stability.

    Measured: One day before surgery, six hours after extubation on the day of surgery, and one day after surgery

  3. State Anxiety (STAI-S) State Anxiety Score Measured by the State-Trait Anxiety Inventory (STAI-S)

    State anxiety will be assessed using the State-Trait Anxiety Inventory - State Form (STAI-S). The scale ranges from 20 to 80, with higher scores indicating higher anxiety levels. Lower scores in the intervention group will reflect reduced situational anxiety.

    Measured: One day before surgery, six hours after extubation on the day of surgery, and one day after surgery

  4. Trait Anxiety (STAI-T)

    Trait anxiety will be assessed using the State-Trait Anxiety Inventory - Trait Form (STAI-T). The scale ranges from 20 to 80, with higher scores indicating higher anxiety levels. A reduction in scores after surgery will indicate decreased persistent anxiety.

    Measured: One day before surgery and one day after surgery

  5. Pain Score (VAS)

    Pain will be evaluated using the Visual Analog Pain Scale, ranging from 0 to 10, where higher scores indicate more severe pain. Differences between groups will determine whether guided visualization meditation contributes to postoperative pain relief.

    Measured: One day before surgery, six hours after extubation on the day of surgery, and one day after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2026
  2. Study start15 Jan 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

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
Nonrandomized, parallel-group clinical trial evaluating the effects of guided visualization meditation compared with standard care in patients undergoing cardiac surgery.
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07379944
Sponsor's protocol ID
2023/358
Acronym
GVM-CARDIO
Status last verified
Jan 2026
First submitted
15 Jan 2026
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared due to patient privacy protections, ethical committee restrictions, and institutional data confidentiality policies. Only aggregated statistical results will be made available upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing Guided Visualization Meditation in people with Cardiac Surgery and Surgical Stress Response, run by University of Gaziantep 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 13 inclusion and 8 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: opening soon, as of the sponsor's last update on 2 Feb 2026. 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. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact TUGBA ALBAYRAM, Dr. (+905548758383, tugbaalbayram@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum Cortisol Level (time frame: One day before surgery, six hours after extubation on the day of surgery, and one day after 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 2 Feb 2026.

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