search
Back to results

The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery. (VRECOVERY)

Primary Purpose

Post Operative Pain, Post Operative Anxiety, Heart Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Virtual Reality distraction therapy
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Academic Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality group

Control Group

Arm Description

Virtual Reality distraction therapy on post-operative days 1,2 and 3.

Conventional post-operative pain and anxiety management

Outcomes

Primary Outcome Measures

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.
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
Quality of Recovery-15
The QoR-15 questionnaire is a clinical validated instrument to measure post-operative quality of recovery.

Secondary Outcome Measures

Full Information

First Posted
August 14, 2023
Last Updated
August 14, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
search

1. Study Identification

Unique Protocol Identification Number
NCT06001502
Brief Title
The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.
Acronym
VRECOVERY
Official Title
The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Post Operative Anxiety, Heart Surgery, Coronary Artery Bypass Grafting, Virtual Reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality group
Arm Type
Experimental
Arm Description
Virtual Reality distraction therapy on post-operative days 1,2 and 3.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Conventional post-operative pain and anxiety management
Intervention Type
Device
Intervention Name(s)
Virtual Reality distraction therapy
Other Intervention Name(s)
Healthy Mind VR device
Intervention Description
The VR device simulates a 3-dimensional virtual enviroment, seeking to immerse the user in virtual surroundings
Primary Outcome Measure Information:
Title
Numeric Rating Scale (NRS)
Description
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.
Time Frame
Post-operative days 1,2 and 3 directly after the VR intervention
Title
State- Trait Anxiety Inventory 6 questionnaire
Description
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
Time Frame
Post-operative days 1,2 and 3 directly after the VR intervention
Title
Quality of Recovery-15
Description
The QoR-15 questionnaire is a clinical validated instrument to measure post-operative quality of recovery.
Time Frame
Post-operative days 1,2 and 3 directly after the VR intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sulayman El Mathari, MD
Phone
+31205668188
Email
s.elmathari@amsterdamumc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jolanda Kluin, MD, PhD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sulayman El Mathari, MD
Phone
+31 205668188
Email
s.elmathari@amsterdamumc.nl

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon request available.
IPD Sharing Time Frame
After publication
IPD Sharing Access Criteria
Upon request available.

Learn more about this trial

The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.

We'll reach out to this number within 24 hrs