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

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Enrolling

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

Treatments: Device: Virtual Reality distraction therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06001502

NL79616.018.21

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Virtual Reality group

Experimental group

Description:

Virtual Reality distraction therapy on post-operative days 1,2 and 3.

Treatment:

Device: Virtual Reality distraction therapy

Control Group

No Intervention group

Description:

Conventional post-operative pain and anxiety management