The Effect of Virtual Reality on Postoperative Pain and Anxiety in Cardiac Surgery.
NCT ID: NCT06001502
Last Updated: 2024-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2023-01-01
2024-09-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Virtual Reality group
Virtual Reality distraction therapy on post-operative days 1,2 and 3.
Virtual Reality distraction therapy
The VR device simulates a 3-dimensional virtual enviroment, seeking to immerse the user in virtual surroundings
Control Group
Conventional post-operative pain and anxiety management
No interventions assigned to this group
Interventions
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Virtual Reality distraction therapy
The VR device simulates a 3-dimensional virtual enviroment, seeking to immerse the user in virtual surroundings
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients undergoing surgical CABG
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Jolanda Kluin
Professor dr. J. Kluin, MD, PhD
Principal Investigators
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Jolanda Kluin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Locations
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Academic Medical Center
Amsterdam, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NL79616.018.21
Identifier Type: -
Identifier Source: org_study_id
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