Coronary Artery Bypass Grafting, Heart Surgery, Post Operative Anxiety, Post Operative Pain, Virtual Reality
Conditions
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.
Interventions
DEVICEVirtual Reality distraction therapy
The VR device simulates a 3-dimensional virtual enviroment, seeking to immerse the user in virtual surroundings
Sponsors
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
Countries
Netherlands
Contacts
Primary ContactSulayman El Mathari, MD
Outcome results
None listed