NCT07523594

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 5, 2026

Last Update Submit

April 5, 2026

Conditions

Keywords

virtual realitymindfulnesspostoperative carecardiovascular surgeryanxiety

Outcome Measures

Primary Outcomes (1)

  • State Anxiety

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

    Baseline, immediately after intervention, 1 hour, and 3 hours

Secondary Outcomes (7)

  • Perceived Stress

    Baseline, 1 hour, and 3 hours

  • Positive and Negative Affect

    Baseline, immediately after intervention, 1 hour, and 3 hours

  • Heart Rate

    Baseline, immediately after intervention, 1 hour, and 3 hours

  • Systolic and Diastolic Blood Pressure

    Baseline, immediately after intervention, 1 hour, and 3 hours

  • Oxygen Saturation (SpO₂)

    Baseline, immediately after intervention, 1 hour, and 3 hours

  • +2 more secondary outcomes

Study Arms (2)

Virtual Reality Mindfulness Group

EXPERIMENTAL

Participants received a 15-minute virtual reality-supported mindfulness meditation session in addition to standard postoperative care.

Behavioral: Virtual Reality-Supported Mindfulness Meditation

Control Group

NO INTERVENTION

Participants received standard postoperative care without any additional intervention.

Interventions

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.

Also known as: Virtual Reality Mindfulness
Virtual Reality Mindfulness Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osmangazi University

Eskişehir, 26000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Melike Pehlivan, PhD

    Kutahya Health Science University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 5, 2026

First Posted

April 13, 2026

Study Start

March 30, 2025

Primary Completion

December 30, 2025

Study Completion

February 2, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to privacy and confidentiality considerations.

Locations