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

Sponsor
Tanta University (Other)
Overall Status
Recruiting
CT.gov ID
NCT06088069
Collaborator
(none)
50
1
2
9.4
5.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual reality
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty: a Randomized Controlled Trial
Actual Study Start Date :
Oct 19, 2023
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group VR

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

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

No Intervention: Group C

Patients will not receive Virtual reality (VR) experience.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. Stress measured by blood serum level of cortisol [6 hours postoperative.]

    Serum cortisol level will be measured before surgery and 6 h

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tanta University Tanta El-Gharbia Egypt 31527

Sponsors and Collaborators

  • Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohammed Said ElSharkawy, Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Tanta University
ClinicalTrials.gov Identifier:
NCT06088069
Other Study ID Numbers:
  • 36264PR331/9/23
First Posted:
Oct 18, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023