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

NCT ID: NCT06933732

Last Updated: 2025-09-26

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-25

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control Group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

2-Hour Postoperative VR Intervention

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

4-Hour Postoperative VR Intervention

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

6-Hour Postoperative VR Intervention

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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

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.

Intervention Type DEVICE

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

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.

Intervention Type DEVICE

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

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aykut Turgut

OTHER

Sponsor Role lead

Responsible Party

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Aykut Turgut

Research Assistant

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Aibu Izzet Baysal Training and Research Hospital

Bolu, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Aykut Turgut, MSc

Role: CONTACT

+905432599683

Facility Contacts

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Aykut Turgut, MSc

Role: primary

+905432599683

Role: backup

Other Identifiers

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AIBU-SBF-AT-02

Identifier Type: -

Identifier Source: org_study_id

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