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Completed

NCT Number: NCT07523594

Virtual Reality Supported Mindfulness Meditation After Cardiovascular Surgery

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Osmangazi University

Eskişehir, 26000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual Reality-Supported Mindfulness Meditation

Behavioral

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: Virtual Reality Mindfulness

Primary outcomes

  1. State Anxiety

    Time frame: Baseline, immediately after intervention, 1 hour, and 3 hours

    State anxiety measured using the State-Trait Anxiety Inventory (STAI-State)

Secondary outcomes

  1. Perceived Stress

    Time frame: Baseline, 1 hour, and 3 hours

    Measured using the Perceived Stress Scale (PSS-4, short form)

  2. Positive and Negative Affect

    Time frame: Baseline, immediately after intervention, 1 hour, and 3 hours

    Measured using the Positive and Negative Affect Schedule (PANAS)

  3. Heart Rate

    Time frame: Baseline, immediately after intervention, 1 hour, and 3 hours

    Measured in beats per minute using a pulse oximeter

  4. Systolic and Diastolic Blood Pressure

    Time frame: Baseline, immediately after intervention, 1 hour, and 3 hours

    Measured in mmHg using a digital blood pressure monitor

  5. Oxygen Saturation (SpO₂)

    Time frame: Baseline, immediately after intervention, 1 hour, and 3 hours

    Measured as percentage (%) using a pulse oximeter

  6. Respiratory Rate

    Time frame: Baseline, immediately after intervention, 1 hour, and 3 hours

    Measured as breaths per minute by manual counting

  7. Body Temperature

    Time frame: Baseline, immediately after intervention, 1 hour, and 3 hours

    Measured in °C using a non-contact thermometer

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Collaborators

  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Effects of Virtual Reality Supported Mindfulness Meditation on Psychophysiological Outcomes In Patients After Cardiovascular Surgery: An Ecological Momentary Assessment Study

Acronym: VR-MIND-CVS

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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