Effectiveness, Satisfaction, and Usability of Virtual Reality in the Management of Postoperative Pain in Patients Undergoing Knee Arthroplasty
NCT ID: NCT07286084
Last Updated: 2025-12-16
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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NOT_YET_RECRUITING
NA
45 participants
INTERVENTIONAL
2025-12-27
2026-12-30
Brief Summary
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The main questions it aims to answer are:
* What is the impact of virtual reality use on postoperative pain perception as measured by the Visual Analogue Scale (VAS)?
* What potential adverse effects are associated with the use of virtual reality in the postoperative context?
* What is the level of satisfaction and acceptance of virtual reality as a complementary strategy for pain management?
* How does virtual reality influence quality of life and psychosocial variables in patients with acute postoperative pain after knee arthroplasty?
Detailed Description
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Three experimental groups will be tested, with interventions performed at three different time points during hospitalization, each session lasting between 10 and 30 minutes. The gaming group will play video games, the control group will view 360° videos, and the usual care group will receive standard analgesia according to the protocol.
Outcome measures will be assessed at baseline (3 months before the intervention), during the intervention, and 1 month after the intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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CONTROL
CONVENTIONAL TREATMENT
No interventions assigned to this group
EXPERIMENTAL
VR GAMES
VIRTUAL REALITY
Interactive VR Games: Participants use Meta Quest 3 head-mounted displays running a custom-developed VR application designed to elicit upper-limb and trunk movements. The application includes multiple structured scenarios:
* Scenario 1 (Painting): Participants perform arm movements using handheld controllers to interact with a virtual painting environment.
* Scenario 2 (Greenhouse): Participants move the arm to attract a butterfly, guide it toward a flower, and complete the assigned interaction task.
* Scenario 3 (Aquarium): Participants perform bilateral arm movements to pop virtual bubbles.
Immersive 360° Videos:Participants use Meta Quest 3 head-mounted displays to view immersive 360° relaxing videos (e.g., natural landscapes accompanied by calming background music).
PLACEBO
VR VIDEOS 360º
VIRTUAL REALITY
Interactive VR Games: Participants use Meta Quest 3 head-mounted displays running a custom-developed VR application designed to elicit upper-limb and trunk movements. The application includes multiple structured scenarios:
* Scenario 1 (Painting): Participants perform arm movements using handheld controllers to interact with a virtual painting environment.
* Scenario 2 (Greenhouse): Participants move the arm to attract a butterfly, guide it toward a flower, and complete the assigned interaction task.
* Scenario 3 (Aquarium): Participants perform bilateral arm movements to pop virtual bubbles.
Immersive 360° Videos:Participants use Meta Quest 3 head-mounted displays to view immersive 360° relaxing videos (e.g., natural landscapes accompanied by calming background music).
Interventions
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VIRTUAL REALITY
Interactive VR Games: Participants use Meta Quest 3 head-mounted displays running a custom-developed VR application designed to elicit upper-limb and trunk movements. The application includes multiple structured scenarios:
* Scenario 1 (Painting): Participants perform arm movements using handheld controllers to interact with a virtual painting environment.
* Scenario 2 (Greenhouse): Participants move the arm to attract a butterfly, guide it toward a flower, and complete the assigned interaction task.
* Scenario 3 (Aquarium): Participants perform bilateral arm movements to pop virtual bubbles.
Immersive 360° Videos:Participants use Meta Quest 3 head-mounted displays to view immersive 360° relaxing videos (e.g., natural landscapes accompanied by calming background music).
Eligibility Criteria
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Inclusion Criteria
* Scheduled unilateral knee arthroplasty
* Adequate cognitive and functional capacity to use virtual reality
* Signed informed consent
Exclusion Criteria
* Significant visual or hearing impairments that hinder VR use
* Physical or motor limitations preventing the use of VR headsets or maintaining the required posture
* Score ≥4 on the 4AT delirium screening tool
* Pregnancy
* Recreational drug or alcohol use
* Inability to complete the intervention protocol
18 Years
ALL
No
Sponsors
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University of Castilla-La Mancha
OTHER
Hospital Universitario del Sureste
OTHER
Universidad Francisco de Vitoria
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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PI 94/25
Identifier Type: -
Identifier Source: org_study_id