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

Post Operative Pain Clinical Trial

— VRECOVERY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001502
• Other study ID #: NL79616.018.21
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: August 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Sulayman El Mathari, MD
• Phone: +31205668188
• Email: s.elmathari[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Coronary Artery Bypass Grafting
• Heart Surgery
• Pain, Postoperative
• Post Operative Pain
• Virtual Reality

Intervention

Device:
• Virtual Reality distraction therapy
The VR device simulates a 3-dimensional virtual enviroment, seeking to immerse the user in virtual surroundings

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord Holland

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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