Virtual RealityNCT06088069
Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty
A study testing Virtual reality in people with Virtual Reality and Total Hip Arthroplasty, run by Tanta University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Virtual Reality, Total Hip Arthroplasty, Anxiety
- What is being tested?
- Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Oct 2023to 5 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years or above.
- Both sexes.
- The American Society of Anesthesiologists (ASA) physical status I-III.
- Scheduled for elective THA under spinal anesthesia.
Who cannot join
- Cerebrovascular disease.
- Psychiatric-cognitive dysfunction.
- Claustrophobia.
- Deaf and blind patients.
- Uncooperative.
- Adrenal insufficiency.
- Chronic alcohol and substance addiction.
- Chronic sedative and narcotic use.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty: a Randomized Controlled Trial
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).
Read the 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.
- Conditions
- Virtual Reality, Total Hip Arthroplasty, Anxiety, Stress, Pain
- Being tested
- Virtual reality
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
Patients will be virtually immersed into a natural universe and soft music for 15 minutes preoperatively and during surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group VR | Experimental | Patients will be virtually immersed into a natural universe and soft music for 15 minutes preoperatively and during surgery. Receives: Other: Virtual reality |
| Group C | No intervention | Patients will not receive Virtual reality (VR) experience. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 min before operation till immediately postoperative.
Secondary outcomes (8)
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.
Measured: Intraoperatively.
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.
Measured: 15 min before operation till immediately postoperative.
Stress measured by blood serum level of cortisol
Serum cortisol level will be measured before surgery and 6 h
Measured: 6 hours postoperative.
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.
Measured: 24 hours postoperatively.
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.
Measured: 24 hours after surgery.
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.
Measured: Till the 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.
Measured: Till the 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).
Measured: 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start19 Oct 2023
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088069
- Sponsor's protocol ID
- 36264PR331/9/23
- Status last verified
- Sep 2024
- First submitted
- 12 Oct 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
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.
PubMed 40922021
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality on Perioperative Anxiety, Stress and Pain in Total Hip Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06088069
- Acronym / sponsor ID
- 36264PR331/9/23
- Conditions
- Virtual Reality, Total Hip Arthroplasty, Anxiety, Stress, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group VR | Experimental | Other: Virtual realityPatients will be virtually immersed into a natural universe and soft music for 15 minutes preoperatively and during surgery. |
| Group C | No intervention | –Patients will not receive Virtual reality (VR) experience. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 21 years or above.
- Both sexes.
- The American Society of Anesthesiologists (ASA) physical status I-III.
- Scheduled for elective THA under spinal anesthesia.
Key exclusion criteria (8 listed)
- Cerebrovascular disease.
- Psychiatric-cognitive dysfunction.
- Claustrophobia.
- Deaf and blind patients.
- Uncooperative.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityPatients will be virtually immersed into a natural universe and soft music for 15 minutes preoperatively and during surgery. | Other | Group VR |
Primary outcome
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.
8 secondary outcomes
Total intraoperative haloperidol consumption
Time frame: Intraoperatively.
Stress measured by Cohen Perceived Stress Scale
Time frame: 15 min before operation till immediately postoperative.
Stress measured by blood serum level of cortisol
Time frame: 6 hours postoperative.
The degree of postoperative pain
Time frame: 24 hours postoperatively.
Amount of opioid consumption
Time frame: 24 hours after surgery.
Heart rate changes
Time frame: Till the end of surgery.
Mean arterial blood pressure changes
Time frame: Till the end of surgery.
Patient satisfaction
Time frame: 24 hours after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40922021Moharam 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.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Virtual Reality and Total Hip Arthroplasty, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 15 min before operation till immediately postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06088069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.