Effectiveness, Satisfaction, and Usability of Virtual Reality in the Management of Postoperative Pain in Patients Undergoing Knee Arthroplasty

Universidad Francisco de Vitoria

Status: Not yet enrolling

Conditions: Knee Arthroplasty

Treatments: Device: VIRTUAL REALITY

Study type: Interventional

Funder types: Other

Identifiers

NCT07286084

PI 94/25

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the effectiveness of using virtual reality glasses to reduce the need for rescue analgesia in patients with acute postoperative pain after knee arthroplasty.

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?

Full description

A single-blind, randomized controlled trial will be conducted to compare gaming, 360° video viewing, and usual care interventions. Participants will be recruited from the prehabilitation clinic at Hospital del Sureste (Arganda del Rey), and the study will follow the CONSORT guidelines for clinical crossover and parallel trials.

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults ≥18 years of age, both sexes
• Scheduled unilateral knee arthroplasty
• Adequate cognitive and functional capacity to use virtual reality
• Signed informed consent

Exclusion criteria

• Neurological or psychiatric disorders (history of epilepsy, seizures, psychosis, schizophrenia, claustrophobia, tremor, rigidity)
• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 3 patient groups, including a placebo group

CONTROL

No Intervention group

Description:

CONVENTIONAL TREATMENT

EXPERIMENTAL

Experimental group

Description:

VR GAMES

Treatment:

Device: VIRTUAL REALITY

PLACEBO

Placebo Comparator group

Description:

VR VIDEOS 360º

Treatment:

Device: VIRTUAL REALITY