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.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Post-operatieve pijn en angst
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters 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
- assessment of analgesic use.
Secondary outcome
-Functional Ambulation Categories Score
Background summary
Post-operative pain and anxiety are common problems in cardiac surgery. These
two components can lead to many adverse outcomes in patients, resulting in a
longer recovery time and a lower overall well-being. Common treatment of these
problems is by use of analgesics such as opioids, NSAIDS and paracetamol.
However, analgesics come with side effects which affect the quality of life.
Therefore there is a need for alternative pain and anxiety management.
Virtual Reality (VR) modalities are currently emerging as non-pharmacological
tools for post-operative pain and anxiety management. Earlier studies in other
surgical fields showed the potential positive effects of VR modalities on
postoperative pain and anxiety. However, such a study is never performed in the
field of cardiac surgery. Therefore we decided to perform a randomized control
trial (RCT) in which we assess the feasibility of VR in postoperative pain and
anxiety management in the field of cardiac surgery.
Study 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.
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.
At follow-up, participants will be called to gather one-time QoR-15 and STAI-6
questionnaire data 6 weeks after the surgery.
Study burden and risks
This is a study with use of a digital VR distraction therapy device. This
device is known to have potential adverse effects of nausea and dizziness.
However, the used software is optimized to minimize these adverse effects. And
the potential benefits of reducing pain and anxiety in the post-surgical phase
outweigh these potential adverse effects.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
A patient undergoing an uncomplicated surgical coronary artery bypass graft
procedure
Exclusion criteria
- Major comorbidities besides coronary artery disease
- Complicated surgical procedure
- Hearing and/or visual impairments
- Facial wounds and skin defects at site of application
- Psychiatric impairments
- Complaints of vomiting and nausea
- History of epilepsy
- Claustrophobia
- Patients placed in clinical isolation
- Readmission to the intensive care unit
Design
Recruitment
Medical products/devices used
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79616.018.21 |