The aim of this study is to determine whether VR used in the pre- and postoperative period after elective orthopedic surgery will decrease pain scores.
ID
Source
Brief title
Condition
- Tendon, ligament and cartilage disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is to evaluate the effect of VR on pain
sensation pre- and postoperative compared to standard care without VR in
patient operated for an ACL-reconstruction
Secondary outcome
The secondary endpoints of this study are to evaluate the effect of VR on
anxiety, pain catastrophizing, analgesic use (daily use of paracetamol, NSAIDs,
opioids), adverse events, patient satisfaction regarding the VR glasses and
length of hospital stay
Background summary
Lack of postoperative acute pain management is associated with increased
morbidity, longer recovery time, more opioid use and subsequently increased
health care costs. There is increasing evidence virtual reality (VR) is
effective in the reduction of acute pain.
However, this is still unknown in patients undergoing surgery for anterior
cruciate ligament (ACL) reconstruction
Study objective
The aim of this study is to determine whether VR used in the pre- and
postoperative period after elective orthopedic surgery will decrease pain
scores.
Study design
A prospective randomized -controlled trial.
Intervention
One group will wear Virtual Reality glasses preoperative, 2h and 4h after the
anterior cruciate ligament reconstruction.
The other group does not wear Virtual Reality glasses.
Study burden and risks
Directly following ACL-reconstruction, the joint will be painful, but this
effect normally disappears in the first weeks after ACL-reconstruction. The
study population experience a negligible medical risk when participating to
this study. They can experience side-effects of VR like for example dizziness
or nausea
dr h vd Hoffplein 1
Sittard-Geleen 6162 BG
NL
dr h vd Hoffplein 1
Sittard-Geleen 6162 BG
NL
Listed location countries
Age
Inclusion criteria
-written an orally given informed consent
- 18 years and older
- Primary ACLR under spinal anaesthesia
- Oral and written informed consent
- Proficient in Dutch
- Medically cleared for participation by surgeon
Exclusion criteria
- Posterolateral corner reconstruction
- General anaesthesia
- Femoral nerve block
- Chronical use of pain medication (opioids)
- Known motion sickness
- Epileptic insults in history
- Claustrophobia
- Blindness
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80151.096.21 |