- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07523594
Virtual Reality Supported Mindfulness Meditation After Cardiovascular Surgery (VR-MIND-CVS)
Effects of Virtual Reality Supported Mindfulness Meditation on Psychophysiological Outcomes In Patients After Cardiovascular Surgery: An Ecological Momentary Assessment Study
The early postoperative period following cardiovascular surgery is often associated with increased anxiety, stress, and physiological instability. Mindfulness-based interventions and virtual reality applications have emerged as potential supportive approaches to improve psychological well-being and promote recovery in clinical settings.
This study aims to examine the short-term effects of virtual reality-supported mindfulness meditation on psychological and physiological outcomes in patients who have completed the intensive care phase after cardiovascular surgery and have been transferred to the ward.
The study was designed as a quasi-experimental trial including 34 patients (intervention group n=17, control group n=17). In addition to standard postoperative care, the intervention group received a 15-minute virtual reality-supported mindfulness meditation session, while the control group received standard care only.
Psychological outcomes include state anxiety, perceived stress, and positive and negative affect. Physiological parameters include heart rate, blood pressure, respiratory rate, oxygen saturation, and body temperature. Data were collected at multiple time points using an ecological momentary assessment approach.
The findings of this study are expected to contribute to the understanding of the feasibility and short-term effects of virtual reality-supported mindfulness interventions in postoperative cardiovascular surgery patients.
Study Overview
Status
Intervention / Treatment
Detailed Description
The early postoperative period following cardiovascular surgery is characterized by increased psychological distress and physiological instability. Patients frequently experience elevated levels of anxiety, perceived stress, and fluctuations in vital signs after being transferred from the intensive care unit to the ward. These factors may negatively affect recovery and overall well-being. Therefore, there is a growing interest in non-pharmacological interventions that can support both psychological and physiological stabilization in this critical period.
Mindfulness-based interventions have been widely used to reduce stress, improve emotional regulation, and enhance overall well-being. In recent years, virtual reality (VR) technologies have been introduced as a novel tool to deliver mindfulness practices through immersive and engaging environments. VR-supported mindfulness may provide a practical and effective approach, particularly for postoperative patients with limited mobility.
This study was designed as a quasi-experimental, non-randomized controlled trial to examine the short-term psychophysiological effects of VR-supported mindfulness meditation in patients after cardiovascular surgery. The study included a total of 34 patients who had completed the intensive care phase and were transferred to the ward (intervention group n=17, control group n=17).
In addition to standard postoperative care, the intervention group received a single 15-minute VR-supported mindful body scan meditation session. The control group received standard care only.
Data collection was conducted using an ecological momentary assessment approach at multiple time points. In the intervention group, measurements were performed before the intervention, immediately after the session (15th minute), at the 1st hour, and at the 3rd hour. In the control group, measurements were obtained at baseline, 1st hour, and 3rd hour.
Psychological outcomes included state anxiety, perceived stress, and positive and negative affect. Physiological parameters included heart rate, systolic and diastolic blood pressure, respiratory rate, oxygen saturation, and body temperature.
The aim of this study is to evaluate the feasibility and short-term effects of VR-supported mindfulness meditation on psychological and physiological outcomes in patients during the early postoperative period following cardiovascular surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Eskişehir, Turkey (Türkiye), 26000
- Osmangazi University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18 to 65 years
- Patients who underwent coronary artery bypass grafting or heart valve repair surgery
- Patients monitored in the postoperative period in the clinical ward following the intensive care unit stay
- Hemodynamically stable patients within the first 12 to 48 hours after surgery, defined as heart rate 60-100 beats/min, blood pressure 90/60-140/90 mmHg, oxygen saturation ≥92%, and respiratory rate 12-20 breaths/min
- Patients who were conscious, able to communicate verbally, and able to understand and follow instructions
- Patients without visual or hearing impairment and physically able to use the virtual reality device
- Patients without a history of psychiatric diagnosis or treatment, based on self-report
- Patients who voluntarily agreed to participate in the study
Exclusion Criteria:
- Patients who underwent major vascular surgery such as aortic aneurysm repair, aortic dissection repair, carotid endarterectomy, or thoracoabdominal aortic aneurysm repair
- Patients who developed serious postoperative complications requiring emergency intervention within the first 12 to 48 hours after surgery, such as acute renal failure, pulmonary embolism, or severe bleeding
- Patients using continuously high-dose beta-blockers or antiarrhythmic drugs due to uncontrolled hypertension or heart failure
- Patients with prior experience in mindfulness meditation
- Patients dependent on mechanical cardiac support devices or requiring continuous mechanical support such as an intra-aortic balloon pump
- Patients diagnosed with delirium or severe cognitive impairment
- Patients under isolation precautions for infection control
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality Mindfulness Group
Participants received a 15-minute virtual reality-supported mindfulness meditation session in addition to standard postoperative care.
|
A 15-minute guided mindfulness body scan meditation delivered through an immersive virtual reality environment in addition to standard postoperative care.
The intervention is designed to support psychological relaxation and physiological stabilization in patients following cardiovascular surgery.
Other Names:
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No Intervention: Control Group
Participants received standard postoperative care without any additional intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Anxiety
Time Frame: Baseline, immediately after intervention, 1 hour, and 3 hours
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State anxiety measured using the State-Trait Anxiety Inventory (STAI-State)
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Baseline, immediately after intervention, 1 hour, and 3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress
Time Frame: Baseline, 1 hour, and 3 hours
|
Measured using the Perceived Stress Scale (PSS-4, short form)
|
Baseline, 1 hour, and 3 hours
|
|
Positive and Negative Affect
Time Frame: Baseline, immediately after intervention, 1 hour, and 3 hours
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Measured using the Positive and Negative Affect Schedule (PANAS)
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Baseline, immediately after intervention, 1 hour, and 3 hours
|
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Heart Rate
Time Frame: Baseline, immediately after intervention, 1 hour, and 3 hours
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Measured in beats per minute using a pulse oximeter
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Baseline, immediately after intervention, 1 hour, and 3 hours
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Systolic and Diastolic Blood Pressure
Time Frame: Baseline, immediately after intervention, 1 hour, and 3 hours
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Measured in mmHg using a digital blood pressure monitor
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Baseline, immediately after intervention, 1 hour, and 3 hours
|
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Oxygen Saturation (SpO₂)
Time Frame: Baseline, immediately after intervention, 1 hour, and 3 hours
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Measured as percentage (%) using a pulse oximeter
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Baseline, immediately after intervention, 1 hour, and 3 hours
|
|
Respiratory Rate
Time Frame: Baseline, immediately after intervention, 1 hour, and 3 hours
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Measured as breaths per minute by manual counting
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Baseline, immediately after intervention, 1 hour, and 3 hours
|
|
Body Temperature
Time Frame: Baseline, immediately after intervention, 1 hour, and 3 hours
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Measured in °C using a non-contact thermometer
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Baseline, immediately after intervention, 1 hour, and 3 hours
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Collaborators and Investigators
Investigators
- Study Director: Melike Pehlivan, PhD, Kutahya Health Science University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 324S805 (Other Grant/Funding Number: TUBITAK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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