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

Not Applicable

Recruiting

• Conditions: Post Operative Pain; Coronary Artery Bypass Grafting; Post Operative Anxiety; Heart Surgery; Virtual Reality
• Interventions: Device: Virtual Reality distraction therapy

• Registration Number: NCT06001502
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-08-14
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2024-08-01
• Study Completion: 2024-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality group	Virtual Reality distraction therapy	Virtual Reality distraction therapy on post-operative days 1,2 and 3.

Primary Outcome Measures

Name	Time	Method
State- Trait Anxiety Inventory 6 questionnaire	Post-operative days 1,2 and 3 directly after the VR intervention	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
Numeric Rating Scale (NRS)	Post-operative days 1,2 and 3 directly after the VR intervention	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.
Quality of Recovery-15	Post-operative days 1,2 and 3 directly after the VR intervention	The QoR-15 questionnaire is a clinical validated instrument to measure post-operative quality of recovery.

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Noord Holland, Netherlands