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Completed

NCT Number: NCT06088069

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

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).

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Key information

Conditions

Virtual Reality Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stress Total Hip Arthroplasty

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality

Other

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

Primary outcomes

  1. 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

  1. Total intraoperative haloperidol consumption

    Time frame: 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

    Time frame: 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

    Time frame: 6 hours postoperative.

    Serum cortisol level will be measured before surgery and 6 h

  4. The degree of postoperative pain

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 18, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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