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

Not Applicable

Recruiting

• Conditions: Stress; Anxiety; Pain; Virtual Reality; Total Hip Arthroplasty
• Interventions: Other: Virtual reality

• Registration Number: NCT06088069
• Lead Sponsor: Tanta University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2023-10
• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-18
• Study Start: 2023-10-19
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23
• Primary Completion: 2024-08-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group VR	Virtual reality	Patients will be virtually immersed into a natural universe and soft music for 15 minutes preoperatively and during surgery.

Primary Outcome Measures

Name	Time	Method
Anxiety	15 min before operation till immediately postoperative.	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.

Secondary Outcome Measures

Name	Time	Method
Stress measured by blood serum level of cortisol	6 hours postoperative.	Serum cortisol level will be measured before surgery and 6 h
Patient satisfaction	24 hours after surgery.	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).
Total intraoperative haloperidol consumption	Intraoperatively.	Rescue sedation (haloperidol 2.5 mg titrated doses till the needed effect) will be given if the patient is still in anxiety.
The degree of postoperative pain	24 hours postoperatively.	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.
Heart rate changes	Till the end of surgery.	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.
Mean arterial blood pressure changes	Till the end of surgery.	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.
Stress measured by Cohen Perceived Stress Scale	15 min before operation till immediately postoperative.	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.
Amount of opioid consumption	24 hours after surgery.	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt