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

NCT06088069 | Completed

• 1 other identifier: 36264PR331/9/23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Virtual Reality; Total Hip Arthroplasty; Anxiety; Stress; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Total intraoperative haloperidol consumption

  Intraoperatively.

• Stress measured by Cohen Perceived Stress Scale

  15 min before operation till immediately postoperative.

• Stress measured by blood serum level of cortisol

  6 hours postoperative.

• The degree of postoperative pain

  24 hours postoperatively.

• Amount of opioid consumption

  24 hours after surgery.

Study Arms (2)

Group VR

EXPERIMENTAL

Patients will be virtually immersed into a natural universe and soft music for 15 minutes preoperatively and during surgery.

Other: Virtual reality

Group C

NO INTERVENTION

Patients will not receive Virtual reality (VR) experience.

Interventions

Virtual reality OTHER

Patients will be virtually immersed into a natural universe and soft music for 15 minutes preoperatively and during surgery.

Group VR

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21 years or above.
• Both sexes.
• The American Society of Anesthesiologists (ASA) physical status I-III.
• Scheduled for elective THA under spinal anesthesia.

You may not qualify if:

• Cerebrovascular disease.
• Psychiatric-cognitive dysfunction.
• Claustrophobia.
• Deaf and blind patients.
• Uncooperative.
• Adrenal insufficiency.
• Chronic alcohol and substance addiction.
• Chronic sedative and narcotic use.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

Related Publications (1)

• Moharam SA, ElSharkawy MS, ELkashef AM, Romeih MA, El Rasool AOAR, Shaheen MM. Effect of virtual reality on perioperative anxiety, stress and pain in total hip arthroplasty: a randomized controlled trial. BMC Anesthesiol. 2025 Sep 9;25(1):446. doi: 10.1186/s12871-025-03316-3.

  PMID: 40922021 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: October 19, 2023
• Primary Completion: August 5, 2024
• Study Completion: August 5, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)