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The effect of virtual reality on anxiety and pain in anterior cruciate ligament reconstruction: a prospective randomized controlled trial

The effect of virtual reality on anxiety and pain in anterior cruciate ligament reconstruction: a prospective randomized controlled trial - VR-ACLR

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON51859
Enrollment
36
Registered
2022-02-21
Start date
2022-03-30
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACL-Rupture. Anterior Cruciate Ligament reconstruction

Interventions

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.

Sponsors

Zuyderland Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)