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NCT Number: NCT06933732

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

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.

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Key information

Conditions

Knee Replacement Agnosia Anxiety Disorders Anxiety, Preoperative Knee Replacement Surgery Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain Management Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain, Acute Signs and Symptoms Virtual Reality

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

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.

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.

    Time frame: 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

    0 = No pain 10 = Worst pain possible

Secondary outcomes

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

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

    Preoperative anxiety will be measured using the State-Trait Anxiety Inventory-State (STAI-S) scale, which is a validated tool for assessing temporary feelings of anxiety. Patients will complete the scale before undergoing any intervention or VR exposure. This measurement will provide an understanding of the patient's baseline anxiety level before the application of VR. This measurement will be taken twice: once before the patients view the educational videos and once after viewing them.

    Total scores range from 20 to 80. Higher scores = Higher levels of anxiety.

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

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

    The Virtual Reality Sickness Questionnaire (VRSQ) assesses the level of discomfort or sickness experienced by participants during or immediately after wearing the Virtual Reality headset.

    Total scores range from 0 to 15, with higher scores indicating higher levels of discomfort or sickness.

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

    Time frame: Postoperative, Day 1

    Patient satisfaction will be measured using a 0-10 Numeric Rating Scale (NRS), where 0 represents no satisfaction and 10 represents the highest level of satisfaction.

  4. Change in Body Temperature (Celsius) from Baseline

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

  5. Change in Heart Rate/min from Baseline

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

  6. Change in Blood Pressure from Baseline (Systolic/Diastolic mmHg)

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

  7. Change in Respiratory Rate/min from Baseline

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

  8. Change in Blood Oxygen Saturation(%) from Baseline

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

Other outcomes

  1. Postoperative Infection Incidence in Participants

    Time frame: Perioperative/Periprocedural

    The incidence of postoperative infections in participants from surgery until discharge. Infections will be identified based on clinical evaluation and standard medical criteria, and recorded for each participant.

  2. Change in Hospital Stay Duration

    Time frame: Perioperative/Periprocedural

    The total duration of the hospital stay, including both preoperative and postoperative periods.

  3. Change in Opioid Usage Postoperatively

    Time frame: Perioperative/Periprocedural

    The total amount of opioids used postoperatively, measured in standardized doses.

Study contacts

Contact information is provided by the study sponsor or research team.

Aykut Turgut, MSc

CONTACT

[email protected]

+905432599683

Sponsors and collaborators

Lead sponsor

Aykut Turgut

Other

Registry information

Official study title

The Effect of Virtual Reality Applications on Patient Outcomes and Satisfaction Before and After Total Knee Replacement: A Randomised Controlled Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2025
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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