Guided Visualization Meditation for Reducing Surgical Stress Response in Cardiac Surgery Patients
GVM-CARDIO
The Effect of Guided Visualization Meditation on Surgical Stress Response in Patients Undergoing Cardiac Surgery: A Nonrandomized Controlled Clinical Trial
1 other identifier
interventional
72
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2026
CompletedStudy Start
First participant enrolled
January 15, 2026
CompletedFirst Posted
Study publicly available on registry
February 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
February 2, 2026
January 1, 2026
12 months
January 15, 2026
January 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
One day before surgery, six hours after extubation on the day of surgery, and one day after surgery
Secondary Outcomes (5)
Serum Glucose Level
One day before surgery, six hours after extubation on the day of surgery, and one day after surgery
Serum Insulin Level
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)
One day before surgery, six hours after extubation on the day of surgery, and one day after surgery
Trait Anxiety (STAI-T)
One day before surgery and one day after surgery
Pain Score (VAS)
One day before surgery, six hours after extubation on the day of surgery, and one day after surgery
Study Arms (2)
Guided Visualization Meditation
EXPERIMENTALA 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 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gaziantep University
Gaziantep, Şehitkamil, 27310, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Tugba ALBAYRAM Study Coordinator / Sub-Investigator, Research Assistant Dr.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant Dr
Study Record Dates
First Submitted
January 15, 2026
First Posted
February 2, 2026
Study Start
January 15, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
February 2, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share
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.