Cardiovascular SurgeryVR-MIND-CVSNCT07523594
Virtual Reality Supported Mindfulness Meditation After Cardiovascular Surgery
A study testing Virtual Reality-Supported Mindfulness Meditation in people with Cardiovascular Surgery and Postoperative Recovery, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cardiovascular Surgery, Postoperative Recovery, Anxiety
- What is being tested?
- Virtual Reality-Supported Mindfulness Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2025to 2 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cardiovascular Surgery, Postoperative Recovery, Anxiety, Stress, Virtual Reality, Mindfulness
- Being tested
- Virtual Reality-Supported Mindfulness Meditation
- Keywords
- virtual reality, mindfulness, postoperative care, cardiovascular surgery, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Supported Mindfulness MeditationBehavioural
Also called Virtual Reality Mindfulness
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Mindfulness Group | Experimental | Participants received a 15-minute virtual reality-supported mindfulness meditation session in addition to standard postoperative care. Receives: Behavioral: Virtual Reality-Supported Mindfulness Meditation |
| Control Group | No intervention | Participants received standard postoperative care without any additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety
State anxiety measured using the State-Trait Anxiety Inventory (STAI-State)
Measured: Baseline, immediately after intervention, 1 hour, and 3 hours
Secondary outcomes (7)
Perceived Stress
Measured using the Perceived Stress Scale (PSS-4, short form)
Measured: Baseline, 1 hour, and 3 hours
Positive and Negative Affect
Measured using the Positive and Negative Affect Schedule (PANAS)
Measured: Baseline, immediately after intervention, 1 hour, and 3 hours
Heart Rate
Measured in beats per minute using a pulse oximeter
Measured: Baseline, immediately after intervention, 1 hour, and 3 hours
Systolic and Diastolic Blood Pressure
Measured in mmHg using a digital blood pressure monitor
Measured: Baseline, immediately after intervention, 1 hour, and 3 hours
Oxygen Saturation (SpO₂)
Measured as percentage (%) using a pulse oximeter
Measured: Baseline, immediately after intervention, 1 hour, and 3 hours
Respiratory Rate
Measured as breaths per minute by manual counting
Measured: Baseline, immediately after intervention, 1 hour, and 3 hours
Body Temperature
Measured in °C using a non-contact thermometer
Measured: Baseline, immediately after intervention, 1 hour, and 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start30 Mar 2025
- Primary completion30 Dec 2025
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to an intervention group and a control group without randomization. The intervention group received a 15-minute virtual reality-supported mindfulness meditation in addition to standard care, while the control group received standard postoperative care only.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Melike Pehlivan, Kutahya Health Sciences University
- Investigators
- Melike Pehlivan, PhD, Study director, Kutahya Health Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523594
- Sponsor's protocol ID
- 324S805
- Other IDs
- 324S805
- Acronym
- VR-MIND-CVS
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Virtual Reality Supported Mindfulness Meditation on Psychophysiological Outcomes In Patients After Cardiovascular Surgery: An Ecological Momentary Assessment Study
- ClinicalTrials.gov ID
- NCT07523594
- Acronym / sponsor ID
- VR-MIND-CVS / 324S805
- Conditions
- Cardiovascular Surgery, Postoperative Recovery, Anxiety, Stress, Virtual Reality, Mindfulness
- Keywords
- virtual reality, mindfulness, postoperative care, cardiovascular surgery, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 13 Apr 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to an intervention group and a control group without randomization. The intervention group received a 15-minute virtual reality-supported mindfulness meditation in addition to standard care, while the control group received standard postoperative care only.
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Mindfulness Group | Experimental | Behavioral: Virtual Reality-Supported Mindfulness MeditationParticipants received a 15-minute virtual reality-supported mindfulness meditation session in addition to standard postoperative care. |
| Control Group | No intervention | –Participants received standard postoperative care without any additional intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Virtual Reality-Supported Mindfulness MeditationAlso: Virtual Reality MindfulnessA 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. | Behavioural | Virtual Reality Mindfulness Group |
Primary outcome
State Anxiety
Time frame: Baseline, immediately after intervention, 1 hour, and 3 hours
State anxiety measured using the State-Trait Anxiety Inventory (STAI-State)
7 secondary outcomes
Perceived Stress
Time frame: Baseline, 1 hour, and 3 hours
Positive and Negative Affect
Time frame: Baseline, immediately after intervention, 1 hour, and 3 hours
Heart Rate
Time frame: Baseline, immediately after intervention, 1 hour, and 3 hours
Systolic and Diastolic Blood Pressure
Time frame: Baseline, immediately after intervention, 1 hour, and 3 hours
Oxygen Saturation (SpO₂)
Time frame: Baseline, immediately after intervention, 1 hour, and 3 hours
Respiratory Rate
Time frame: Baseline, immediately after intervention, 1 hour, and 3 hours
Body Temperature
Time frame: Baseline, immediately after intervention, 1 hour, and 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations.
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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. This study is not recruiting at the moment.
Melike Pehlivan, PhD study director
Kutahya Health Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Supported Mindfulness Meditation in people with Cardiovascular Surgery and Postoperative Recovery, run by Kutahya Health Sciences University 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 13 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State Anxiety (time frame: Baseline, immediately after intervention, 1 hour, and 3 hours). 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 13 Apr 2026.