The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post Operative Pain
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- State- Trait Anxiety Inventory 6 questionnaire
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Jolanda Kluin
Professor dr. J. Kluin, MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Eligibility Criteria
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
Outcomes
Primary Outcomes
State- Trait Anxiety Inventory 6 questionnaire
Time Frame: 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)
Time Frame: 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
Time Frame: 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.