Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty

Study Overview
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Brief Summary
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The aim of this study is to evaluate Virtual reality (VR) on perioperative anxiety, pain, hemodynamics, and stress hormones in patients undergoing Total hip arthroplasty (THA).

Detailed Description
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VR is a computer technology that provides the feeling of being immersed in a simulated three-dimensional (3D) world where the user may interact with the virtual environment. Clinical studies have shown that VR technology is effective in reducing pain perception and anxiety. It has also been proposed as an effective non-pharmacological alternative for reducing acute procedural pain and providing anxiety relief.

Official Title
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Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty: a Randomized Controlled Trial

Conditions
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Virtual Reality, Total Hip Arthroplasty, Anxiety, Stress, Pain

Intervention / Treatment
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* Other: Virtual reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 21 years or above. Both sexes. The American Society of Anesthesiologists (ASA) physical status I-III. Scheduled for elective THA under spinal anesthesia. Exclusion Criteria: Cerebrovascular disease. Psychiatric-cognitive dysfunction. Claustrophobia. Deaf and blind patients. Uncooperative. Adrenal insufficiency. Chronic alcohol and substance addiction. Chronic sedative and narcotic use.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group VR<br>Patients will be virtually immersed into a natural universe and soft music for 15 minutes preoperatively and during surgery. | Other: Virtual reality<br>* Patients will be virtually immersed into a natural universe and soft music for 15 minutes preoperatively and during surgery.<br>|
| No Intervention: Group C<br>Patients will not receive Virtual reality (VR) experience. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Each patient will be instructed about the scores; State Anxiety Inventory (STAI-S). The Arabic validated version of STAI-S test will be provided to the patients to determine the anxiety levels. Scores vary between and 20-80 with high scores associated with higher anxiety levels. Patients will be asked to read each statement and then indicate how they were feeling at that moment by marking the appropriate parentheses on the right side of each statement. Anxiety will be measured at baseline (15 min before operation), before spinal anesthesia and immediately postoperative. | 15 min before operation till immediately postoperative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total intraoperative haloperidol consumption | Rescue sedation (haloperidol 2.5 mg titrated doses till the needed effect) will be given if the patient is still in anxiety. | Intraoperatively. | 
| Stress measured by Cohen Perceived Stress Scale | Patients will be asked about feelings and thoughts during the last month to indicate how often you felt or thought a certain way on a five-point scale from 'never' to 'very often'. Answers are then scored as follow: Never=0, Almost never=1, Sometimes=2, Fairly often=3, Very often=4. It consists of 10 questions, takes 5-10 minutes to complete and is for individual or group administration. Stress scores will be measured at baseline (15 min before operation), before spinal anesthesia and immediately postoperative. | 15 min before operation till immediately postoperative. | 
| Stress measured by blood serum level of cortisol | Serum cortisol level will be measured before surgery and 6 h | 6 hours postoperative. | 
| The degree of postoperative pain | Numerical Rating Scale(NRS) will be assessed to evaluate postoperative pain and ask patients to rate their level of pain at 30 minutes and then at 2, 4, 6, 12, 18 and 24 hours postoperative on a scale specifically adapted for this purpose. Each patient obtained a score between 0 and 10. | 24 hours postoperatively. | 
| Amount of opioid consumption | All patients will be given paracetamol 1 g as routine analgesia. If Numerical Rating Scale (NRS) > 3 is observed, rescue analgesia (pethidine 0.5 mg IV) will be administered. | 24 hours after surgery. | 
| Heart rate changes | Heart rate (HR) will be measured at baseline, before spinal anesthesia , and 5, 10, 15, 30, 60, 90 and 120 minutes intraoperatively and at end of surgery. | Till the end of surgery. | 
| Mean arterial blood pressure changes | Mean arterial blood pressure will be measured at baseline, before spinal anesthesia , and 5, 10, 15, 30, 60, 90 and 120 minutes intraoperatively and at end of surgery. | Till the end of surgery. | 
| Patient satisfaction | Patient satisfaction will be assessed on a 5-point likert scale Patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied ; 5, extremely satisfied). | 24 hours after surgery. |