Back to resultsEffect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty
Primary Purpose
Virtual Reality, Total Hip Arthroplasty, Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
About this trial
This is an interventional treatment trial for Virtual Reality
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.
Sites / Locations
- Tanta UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group VR
Group C
Arm Description
Patients will be virtually immersed into a natural universe and soft music for 15 minutes preoperatively and during surgery.
Patients will not receive Virtual reality (VR) experience.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Stress measured by blood serum level of cortisol
Serum cortisol level will be measured before surgery and 6 h
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.
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.
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06088069
Brief Title
Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty
Official Title
Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2023 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Virtual Reality, Total Hip Arthroplasty, Anxiety, Stress, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group VR
Arm Type
Experimental
Arm Description
Patients will be virtually immersed into a natural universe and soft music for 15 minutes preoperatively and during surgery.
Arm Title
Group C
Arm Type
No Intervention
Arm Description
Patients will not receive Virtual reality (VR) experience.
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
Patients will be virtually immersed into a natural universe and soft music for 15 minutes preoperatively and during surgery.
Primary Outcome Measure Information:
Title
Anxiety
Description
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.
Time Frame
15 min before operation till immediately postoperative.
Secondary Outcome Measure Information:
Title
Total intraoperative haloperidol consumption
Description
Rescue sedation (haloperidol 2.5 mg titrated doses till the needed effect) will be given if the patient is still in anxiety.
Time Frame
Intraoperatively.
Title
Stress measured by Cohen Perceived Stress Scale
Description
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.
Time Frame
15 min before operation till immediately postoperative.
Title
Stress measured by blood serum level of cortisol
Description
Serum cortisol level will be measured before surgery and 6 h
Time Frame
6 hours postoperative.
Title
The degree of postoperative pain
Description
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.
Time Frame
24 hours postoperatively.
Title
Amount of opioid consumption
Description
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.
Time Frame
24 hours after surgery.
Title
Heart rate changes
Description
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.
Time Frame
Till the end of surgery.
Title
Mean arterial blood pressure changes
Description
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.
Time Frame
Till the end of surgery.
Title
Patient satisfaction
Description
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).
Time Frame
24 hours after surgery.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed S ElSharkawy, MD
Phone
00201021559948
Email
mselsharkawy@med.tanta.edu.eg
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El-Gharbia
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed S ElSharkawy, Master
Phone
00201021559948
Email
mselsharkawy@med.tanta.edu.eg
First Name & Middle Initial & Last Name & Degree
Saad A Moharam, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
IPD Sharing Time Frame
After the end of study for one year.
IPD Sharing Access Criteria
The data will be available upon a reasonable request from the corresponding author.
Learn more about this trial
Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty
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