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).
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
- Conditions the study is for
- Cardiac Surgery, Surgical Stress Response, Coronary Artery Disease
- What is being tested?
- Guided Visualization Meditation
- Type of treatment
- Lifestyle or therapy programme
- 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 Study Coordinator / Sub-Investigator, Research Assistant Dr. contact
Turkey (Türkiye)1 site
Gaziantep University
Gaziantep, Şehitkamil, 27310
TUGBA ALBAYRAM, 05548758383, tugbaalbayram@gmail.com
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.
- Conditions
- Cardiac Surgery, Surgical Stress Response, Coronary Artery Disease, Postoperative Stress, Anxiety
- 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 group | Role | What they receive |
|---|---|---|
| Guided Visualization Meditation | Experimental | 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. Receives: Behavioral: Guided Visualization Meditation |
| Standard Care | No intervention | Participants 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.
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)
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
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
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
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
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.
- First posted2 Feb 2026
- Study start15 Jan 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Albayram, University of Gaziantep
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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Guided Visualization Meditation on Surgical Stress Response in Patients Undergoing Cardiac Surgery: A Nonrandomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07379944
- Acronym / sponsor ID
- GVM-CARDIO / 2023/358
- Conditions
- Cardiac Surgery, Surgical Stress Response, Coronary Artery Disease, Postoperative Stress, Anxiety
- Keywords
- guided visualization, meditation, mind-body intervention, STAI, perioperative care, cardiac surgery patients, insulin resistance, blood glucose
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Feb 2026 (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 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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Nonrandomized, parallel-group clinical trial evaluating the effects of guided visualization meditation compared with standard care in patients undergoing cardiac surgery.
| Arm | Type | Receives |
|---|---|---|
| Guided Visualization Meditation | Experimental | Behavioral: Guided Visualization MeditationA 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. |
| Standard Care | No intervention | –Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- Prolonged or complicated surgery
- Withdrawal of consent at any stage
- Postoperative altered consciousness (GCS < 15)
- Perioperative administration of corticosteroids
- Severe intraoperative complications
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 |
|---|---|---|
| Guided Visualization MeditationA 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. | Behavioural | Guided Visualization Meditation |
Primary outcome
Serum Cortisol Level
Time frame: One day before surgery, six hours after extubation on the day of surgery, and one day after surgery
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.
5 secondary outcomes
Serum Glucose Level
Time frame: One day before surgery, six hours after extubation on the day of surgery, and one day after surgery
Serum Insulin Level
Time frame: One day before surgery, six hours after extubation on the day of surgery, and one day after surgery
State Anxiety (STAI-S) State Anxiety Score Measured by the State-Trait Anxiety Inventory (STAI-S)
Time frame: One day before surgery, six hours after extubation on the day of surgery, and one day after surgery
Trait Anxiety (STAI-T)
Time frame: One day before surgery and one day after surgery
Pain Score (VAS)
Time frame: One day before surgery, six hours after extubation on the day of surgery, and one day after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: 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.
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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.
Tugba ALBAYRAM Study Coordinator / Sub-Investigator, Research Assistant Dr. contact
1 site in 1 country: see every site and its status.
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.