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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088069
• Other study ID #: 36264PR331/9/23
• Status: Recruiting
• Phase: N/A
• Start date: October 19, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: October 2023
• Source: Tanta University
• Contact: Mohammed S ElSharkawy, MD
• Phone: 00201021559948
• Email: mselsharkawy[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain
• Stress
• Total Hip Arthroplasty
• Virtual Reality

Intervention

Other:
• Virtual reality
Patients will be virtually immersed into a natural universe and soft music for 15 minutes preoperatively and during surgery.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	Stress measured by blood serum level of cortisol	Serum cortisol level will be measured before surgery and 6 h	6 hours postoperative.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.