The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.

Study Overview
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Brief Summary
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The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure. Participants in the intervention group will receive a 20 minute session with the head mounted VR device on post-operative days 1,2 and 3. Participants in the control group will be treated with conventional post-operative care.

Detailed Description
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Objective: The objective of this study is to investigate the effect of VR on post-operative pain and anxiety management in cardiac surgery patients undergoing a coronary artery bypass grafting (CABG) procedure. Study design: This study is a single-center randomized control trial. Study population: Patients who have undergone a CABG procedure (n=100). Intervention: The intervention group (n=50) will use the VR distraction therapy device at day 1, 2 and 3 after surgery on the general ward. The control group (n=50) will be treated with conventional post-operative pain and anxiety management. Main study parameters/endpoints: The main study parameters at day 1, 2 and 3 after surgery. These are the Numeric Rating Scale (NRS) to assess the effect of pain on mobility, the Quality of Recovery-15 questionnaire, the State-Trait Anxiety Inventory-6 questionnaire and assessment of analgesic use. At follow-up, participants will be called to gather one-time QoR-15 and STAI-6 questionnaire data 6 weeks after the surgery.

Official Title
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The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.

Conditions
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Post Operative Pain, Post Operative Anxiety, Heart Surgery, Coronary Artery Bypass Grafting, Virtual Reality

Intervention / Treatment
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* Device: Virtual Reality distraction therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years or older with written informed consent Patients undergoing surgical CABG Exclusion Criteria: Major comorbidities besides coronary artery disease Complicated surgical procedure Hearing and/or visual impairments Psychiatric impairments Complaints of vomiting and nausea History of epilepsy Claustrophobia Facial wounds and skin defects at site of application Patients placed in clinical isolation Readmission to the intensive care unit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality group<br>Virtual Reality distraction therapy on post-operative days 1,2 and 3. | Device: Virtual Reality distraction therapy<br>* The VR device simulates a 3-dimensional virtual enviroment, seeking to immerse the user in virtual surroundings<br>* Other names: Healthy Mind VR device;|
| No Intervention: Control Group<br>Conventional post-operative pain and anxiety management | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale (NRS) | The NRS score is a numeric scale in which individuals rate pain from 0 (no pain) tot 10 (worst pain). This is a subjective score which is assessed verbally and used frequently in standard clinical care in multiple medical specialties. | Post-operative days 1,2 and 3 directly after the VR intervention | 
| State- Trait Anxiety Inventory 6 questionnaire | The STAI-6 questionnaire is a validated psychological inventory designed to measure worry, tension and anxiety in an individual. It is a shortend version of the STAI score | Post-operative days 1,2 and 3 directly after the VR intervention | 
| Quality of Recovery-15 | The QoR-15 questionnaire is a clinical validated instrument to measure post-operative quality of recovery. | Post-operative days 1,2 and 3 directly after the VR intervention |