Skip to main content
Clinical Trials/NCT06088069
NCT06088069
Recruiting
Not Applicable

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

Tanta University1 site in 1 country50 target enrollmentOctober 19, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Virtual Reality
Sponsor
Tanta University
Enrollment
50
Locations
1
Primary Endpoint
Anxiety
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 19, 2023
End Date
August 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Tanta University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Anxiety

Time Frame: 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 Outcomes

  • Stress measured by blood serum level of cortisol(6 hours postoperative.)
  • Patient satisfaction(24 hours after surgery.)
  • Total intraoperative haloperidol consumption(Intraoperatively.)
  • The degree of postoperative pain(24 hours postoperatively.)
  • Heart rate changes(Till the end of surgery.)
  • Mean arterial blood pressure changes(Till the end of surgery.)
  • Stress measured by Cohen Perceived Stress Scale(15 min before operation till immediately postoperative.)
  • Amount of opioid consumption(24 hours after surgery.)

Study Sites (1)

Loading locations...

Similar Trials