Clinical trial NCT06001502: The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.
Official title: The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Operative Pain
Post Operative Anxiety
Heart Surgery
Coronary Artery Bypass Grafting
Virtual Reality
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Numeric Rating Scale (NRS)
timeFrame: Post-operative days 1,2 and 3 directly after the VR intervention
measure: State- Trait Anxiety Inventory 6 questionnaire
timeFrame: Post-operative days 1,2 and 3 directly after the VR intervention
measure: Quality of Recovery-15
timeFrame: Post-operative days 1,2 and 3 directly after the VR intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Jolanda Kluin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: