The effect of virtual reality on anxiety and pain in anterior cruciate ligament reconstruction: a prospective randomized controlled trial
Phase 3
Completed
- Conditions
- ACL-Rupture.Anterior Cruciate Ligament reconstruction10043237
- Registration Number
- NL-OMON51859
- Lead Sponsor
- Zuyderland Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 36
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint of this study is to evaluate the effect of VR on pain<br /><br>sensation pre- and postoperative compared to standard care without VR in<br /><br>patient operated for an ACL-reconstruction</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints of this study are to evaluate the effect of VR on<br /><br>anxiety, pain catastrophizing, analgesic use (daily use of paracetamol, NSAIDs,<br /><br>opioids), adverse events, patient satisfaction regarding the VR glasses and<br /><br>length of hospital stay </p><br>