Trials / Recruiting
RecruitingNCT06001502
The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Post Operative Pain
- Post Operative Anxiety
- Heart Surgery
- Coronary Artery Bypass Grafting
- Virtual Reality
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Virtual Reality distraction therapy | The VR device simulates a 3-dimensional virtual enviroment, seeking to immerse the user in virtual surroundings |
Timeline
- Start date
- 2023-01-01
- Primary completion
- 2024-08-01
- Completion
- 2024-09-01
- First posted
- 2023-08-21
- Last updated
- 2024-07-10
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT06001502. Inclusion in this directory is not an endorsement.