Clinical trial NCT06933732: Effect of Virtual Reality on Patient Outcomes and Satisfaction in Total Knee Replacement
Official title: The Effect of Virtual Reality Applications on Patient Outcomes and Satisfaction Before and After Total Knee Replacement: A Randomised Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Knee Replacement
Knee Replacement Surgery
Postoperative Pain, Acute
Anxiety, Preoperative
Pain Management
Virtual Reality
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2025-04-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the effectiveness of virtual reality (VR) in managing preoperative anxiety and postoperative pain in patients undergoing total knee replacement. Investigators will assess the impact of preoperative VR training on anxiety levels, explore the effectiveness of relaxing and distracting VR videos for pain management after surgery, and determine the optimal timing for VR application by comparing different VR intervention times. Our goal is to identify how VR can improve both the emotional and physical recovery process for patients undergoing knee replacement surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with an ASA score of 1, 2, or 3
* Elective unilateral total knee replacement surgery was planned,
* Patients who are able to read and write in Turkish

Exclusion Criteria:

* Using \>30 mg of oral oxycodone or equivalent daily
* Long-term opioid use (\>12 weeks)
* Substance use disorder
* Scheduled for emergency surgery
* Scheduled for revision surgery
* Requiring postoperative intensive care
* Patients with visual or hearing impairments
* Individuals experiencing motion-related nausea or dizziness
* History of stroke or dementia
* Pregnant or breastfeeding women
* Patients with a history of epilepsy or seizures

Primary outcomes:
measure: Change from Baseline in Postoperative Pain Intensity as Measured by Visual Analogue Scale (VAS) at 2, 4, and 6 Hours After Surgery in Patients Receiving Virtual Reality Interventions.
timeFrame: Baseline (before VR intervention) and assessments at 2, 4, and 6 hours after surgery, with a 15-Minute wait after VR video completion before each pain assessment
Secondary outcomes:
measure: Preoperative Anxiety Measured Using the State-Trait Anxiety Inventory-State (STAI-S) Scale
timeFrame: Baseline (just before the educational video) and post-video (immediately after the educational video, Day 1)
measure: Change from Baseline in Virtual Reality Sickness as Measured by the Virtual Reality Sickness Questionnaire (VRSQ)
timeFrame: Baseline (just before the educational video) and post-video (immediately after the educational video, Day 1)
measure: Patient Satisfaction as Measured by a 0-10 Numeric Rating Scale Post-Intervention
timeFrame: Postoperative, Day 1
measure: Change in Body Temperature (Celsius) from Baseline
timeFrame: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
measure: Change in Heart Rate/min from Baseline
timeFrame: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
measure: Change in Blood Pressure from Baseline (Systolic/Diastolic mmHg)
timeFrame: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
measure: Change in Respiratory Rate/min from Baseline
timeFrame: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
measure: Change in Blood Oxygen Saturation(%) from Baseline
timeFrame: Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
Other outcomes:
measure: Postoperative Infection Incidence in Participants
timeFrame: Perioperative/Periprocedural
measure: Change in Hospital Stay Duration
timeFrame: Perioperative/Periprocedural
measure: Change in Opioid Usage Postoperatively
timeFrame: Perioperative/Periprocedural
Locations:
city: Bolu
country: Turkey
facility: Aibu Izzet Baysal Training and Research Hospital
Study officials:
References: