Anxiety, Preoperative, Knee Replacement, Knee Replacement Surgery, Pain Management, Postoperative Pain, Acute, Virtual Reality
Conditions
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.
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.
Sponsors
Aykut Turgut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 Blood Pressure from Baseline (Systolic/Diastolic mmHg) | Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group. | — |
| Change in Respiratory Rate/min from Baseline | Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group. | — |
| Change in Blood Oxygen Saturation(%) from Baseline | Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group. | — |
| 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) | 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. |
| 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) | 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. |
| Patient Satisfaction as Measured by a 0-10 Numeric Rating Scale Post-Intervention | 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Opioid Usage Postoperatively | Perioperative/Periprocedural | The total amount of opioids used postoperatively, measured in standardized doses. |
| Change in Hospital Stay Duration | Perioperative/Periprocedural | The total duration of the hospital stay, including both preoperative and postoperative periods. |
| Postoperative Infection Incidence in Participants | 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactAykut Turgut, MSc
Outcome results
None listed