Effect of Virtual Reality on Patient Outcomes and Satisfaction in Total Knee Replacement

NCT06933732 | Not Yet Recruiting

• 1 other identifier: AIBU-SBF-AT-02
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Replacement; Knee Replacement Surgery; Postoperative Pain, Acute; Anxiety, Preoperative; Pain Management; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• 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.

  0 = No pain 10 = Worst pain possible

  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 (8)

• Preoperative Anxiety Measured Using the State-Trait Anxiety Inventory-State (STAI-S) Scale

  Baseline (just before the educational video) and post-video (immediately after the educational video, Day 1)

• Change from Baseline in Virtual Reality Sickness as Measured by the Virtual Reality Sickness Questionnaire (VRSQ)

  Baseline (just before the educational video) and post-video (immediately after the educational video, Day 1)

• Patient Satisfaction as Measured by a 0-10 Numeric Rating Scale Post-Intervention

  Postoperative, Day 1

• Change in Body Temperature (Celsius) from Baseline

  Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.

• Change in Heart Rate/min from Baseline

  Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.

Other Outcomes (3)

• Postoperative Infection Incidence in Participants

  Perioperative/Periprocedural

• Change in Hospital Stay Duration

  Perioperative/Periprocedural

• Change in Opioid Usage Postoperatively

  Perioperative/Periprocedural

Study Arms (4)

Control Group

NO INTERVENTION

Participants in this group will receive standard care, which includes preoperative education about the surgical process via an educational video and the completion of informed consent. No virtual reality intervention will be provided during their recovery.

2-Hour Postoperative VR Intervention

EXPERIMENTAL

Participants in this group will first watch an educational VR video about the surgery before the procedure. Two hours post-surgery, they will be exposed to a VR intervention featuring calming nature videos.

Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (2 hours)

4-Hour Postoperative VR Intervention

EXPERIMENTAL

Participants in this group will first watch an educational VR video about the surgery before the procedure. Four hours post-surgery, they will be exposed to a VR intervention featuring calming nature videos.

Device: Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (4 hours)

6-Hour Postoperative VR Intervention

EXPERIMENTAL

Participants in this group will first watch an educational VR video about the surgery before the procedure. Six hours post-surgery, they will be exposed to a VR intervention featuring calming nature videos.

Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (6 hours)

Interventions

Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (2 hours) DEVICE

The Virtual Reality intervention involves participants wearing a VR headset at least one hour prior to their surgery to watch immersive, pre-recorded educational videos showing the operating room with a nurse explaining the process aimed at reducing pre-operative anxiety and nature videos with distraction effect after surgery for pain management. The intervention for pain management will be delivered 2 hours after surgery. The videos to be shown to patients will be limited to a maximum of 30 minutes. In addition, all participants will be reminded that they can remove the glasses or leave the study at any time.

2-Hour Postoperative VR Intervention

Device: Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (4 hours) DEVICE

The Virtual Reality intervention involves participants wearing a VR headset at least one hour prior to their surgery to watch immersive, pre-recorded educational videos showing the operating room with a nurse explaining the process aimed at reducing pre-operative anxiety and nature videos with distraction effect after surgery for pain management. The intervention for pain management will be delivered 4 hours after surgery. The videos to be shown to patients will be limited to a maximum of 30 minutes. In addition, all participants will be reminded that they can remove the glasses or leave the study at any time.

4-Hour Postoperative VR Intervention

Virtual Reality Intervention for Preoperative Anxiety and Postoperative Pain Management (6 hours) DEVICE

The Virtual Reality intervention involves participants wearing a VR headset at least one hour prior to their surgery to watch immersive, pre-recorded educational videos showing the operating room with a nurse explaining the process aimed at reducing pre-operative anxiety and nature videos with distraction effect after surgery for pain management. The intervention for pain management will be delivered 6 hours after surgery. The videos to be shown to patients will be limited to a maximum of 30 minutes. In addition, all participants will be reminded that they can remove the glasses or leave the study at any time.

6-Hour Postoperative VR Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aykut Turgut: lead

Study Sites (1)

Aibu Izzet Baysal Training and Research Hospital

Bolu, 14280, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Aykut Turgut, MSc

CONTACT

+905432599683; turgut_aykut@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: April 18, 2025
• Study Start: December 25, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: September 26, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)