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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual Reality group | Experimental | Virtual Reality distraction therapy on post-operative days 1,2 and 3. |
|
| Control Group | No Intervention | Conventional post-operative pain and anxiety management |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality distraction therapy | Device | The VR device simulates a 3-dimensional virtual enviroment, seeking to immerse the user in virtual surroundings |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sulayman El Mathari, MD | Contact | +31205668188 | s.elmathari@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Jolanda Kluin, MD, PhD | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Medical Center | Recruiting | Amsterdam | North Holland | 1105 AZ | Netherlands |
Upon request available.
After publication
Upon request available.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2022 |
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|
| May 30, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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