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

Browse trials for

• Pain, Postoperative 5,093
• Anxiety Disorders 4,868
• Agnosia 1,190

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 64 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Lead sponsor

This is the only study on the registry with Aykut Turgut as lead sponsor.

Study arms

• No intervention
  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.

• Experimental
  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.

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

• Experimental
  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.

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

• Experimental
  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.

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

Interventions

• DeviceVirtual 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.

• DeviceDevice: 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.

• DeviceVirtual 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.

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

   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

Secondary outcomes

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

   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.

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

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

   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.

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

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

   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.

   Time frame: Postoperative, Day 1

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

   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.

   Time frame: Perioperative/Periprocedural

2. Change in Hospital Stay Duration

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

   Time frame: Perioperative/Periprocedural

3. Change in Opioid Usage Postoperatively

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

   Time frame: Perioperative/Periprocedural

Individual participant data

Plan to share: No — IPD is not planned to be shared at this time, as it is considered important to first publish the data in the form of a manuscript.