Hip OsteoarthritisVRNCT07705451
Virtual Reality for Intraoperative Anxiolysis and Postoperative Agitation in Elderely Hip Arthroplasty Patients
A study testing immersive virtual reality and standard sedation in people with Hip Osteoarthritis and Hip Arthroplasty Replacement, run by Menoufia University.
Trial summary
This study evaluates the effectiveness of Virtual Reality (VR) as a non-pharmacological intervention to reduce intraoperative anxiety and postoperative agitation in elderly patients undergoing elective hip arthroplasty under regional anesthesia. Read more about this study
- Who is it for?
- Ages 45 months to 75 years
- Conditions the study is for
- Hip Osteoarthritis, Hip Arthroplasty Replacement, Emergence Delirium, Anesthesia
- What is being tested?
- immersive virtual reality and standard sedation
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2026to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 months to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients scheduled for elective cemented or uncemented hip arthroplasty under regional (spinal or epidural) anesthesia.
- ASA physical status I-III.
- Mentally capable of providing informed consent.
Who cannot join
- Pre-existing cognitive impairment or dementia (as assessed by the Mini-Mental State Examination).
- Severe uncorrected visual or hearing impairments that prevent VR device tolerance.
- Severe psychiatric disorders (e.g., schizophrenia, bipolar disorder).
- General contraindications to regional anesthesia (e.g., localized back infection, severe coagulopathy).
- Inability to physically tolerate or adjust to the VR headset
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Using Virtual Reality on Intraoperative Anxiolysis and Postoperative Agitation in Older Patients Undergoing Hip Arthroplasty Under Regional Anesthesia
This study evaluates the effectiveness of Virtual Reality (VR) as a non-pharmacological intervention to reduce intraoperative anxiety and postoperative agitation in elderly patients undergoing elective hip arthroplasty under regional anesthesia. Half of the patients will experience an immersive, calming nature-based VR environment during the surgery, while the control group will receive standard care.
- Conditions
- Hip Osteoarthritis, Hip Arthroplasty Replacement, Emergence Delirium, Anesthesia, Emergence Agitation, Hip Fracture Surgeries, Postoperative Anxiety
- Being tested
- immersive virtual reality, standard sedation
- Medical subject headings
- Osteoarthritis, Hip, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immersive virtual realityDevice
A VR headset will be placed on the patient's head 5 minutes before the administration of spinal anesthesia. Throughout the intraoperative procedure under regional anesthesia, the patient will experience an immersive, calming, nature-based VR environment (such as underwater ocean scenes or forest walks) via specialized sights and sounds. This acts as a non-pharmacological distraction technique to reduce intraoperative anxiety and subsequently alleviate postoperative emergence agitation
standard sedationProcedure or surgery
Patients will undergo standard preparation and management for elective hip arthroplasty under regional anesthesia. The intraoperative phase will follow routine institutional sedation and analgesia protocols using conventional pharmacological agents (e.g., midazolam, fentanyl) titrated based on standard clinical needs. To ensure robust triple-blinding, patients in this group will wear an opaque eye mask during the procedure to match the physical presence of a headset.
| Study group | Role | What they receive |
|---|---|---|
| VR | Experimental | Patients will use a VR headset placed 5 minutes before spinal anesthesia and throughout the procedure, experiencing an immersive, calming nature-based environment (e.g., underwater ocean scenes, forest walks) Receives: Device: immersive virtual reality |
| control | Active comparator | Patients will receive standard regional anesthesia with routine institutional sedation protocols (e.g., midazolam, fentanyl) without any VR intervention. They will wear an opaque eye mask to maintain blinding Receives: Procedure: standard sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Agitation
Postoperative emergence agitation will be assessed using the unabbreviated Riker Sedation-Agitation Scale (SAS). The score ranges from a minimum value of 1 (unarousable) to a maximum value of 7 (dangerous agitation). A score of 4 indicates a calm and cooperative patient, while scores from 5 to 7 indicate increasing levels of agitation (higher scores mean worse agitation outcomes
Measured: From the immediate arrival at the post-anesthesia care unit (PACU) up to 6 hours postoperatively.
Intraoperative Anxiety
Intraoperative anxiety and sedation levels will be evaluated using the unabbreviated Ramsay Sedation Scale (RSS). The score ranges from a minimum value of 1 (patient anxious and agitated or restless) to a maximum value of 6 (patient asleep with no response). Lower scores indicate higher anxiety and agitation levels, while higher scores indicate deeper sedation and better anxiety control.
Measured: badeline (Pre-procedure), intraoperatively (every 1 hour), andat 1 hour post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start10 Jul 2026 (estimated)
- Primary completion20 Aug 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mostafa saieed fahim mansour, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705451
- Sponsor's protocol ID
- 4/2026ANET1
- Acronym
- VR
- Status last verified
- Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Virtual Reality on Intraoperative Anxiolysis and Postoperative Agitation in Older Patients Undergoing Hip Arthroplasty Under Regional Anesthesia
- ClinicalTrials.gov ID
- NCT07705451
- Acronym / sponsor ID
- VR / 4/2026ANET1
- Conditions
- Hip Osteoarthritis, Hip Arthroplasty Replacement, Emergence Delirium, Anesthesia, Emergence Agitation, Hip Fracture Surgeries, Postoperative Anxiety
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 20 Aug 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 15 Jul 2026 (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.
This study evaluates the effectiveness of Virtual Reality (VR) as a non-pharmacological intervention to reduce intraoperative anxiety and postoperative agitation in elderly patients undergoing elective hip arthroplasty under regional anesthesia. Half of the patients will experience an immersive, calming nature-based VR environment during the surgery, while the control group will receive standard care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR | Experimental | Device: immersive virtual realityPatients will use a VR headset placed 5 minutes before spinal anesthesia and throughout the procedure, experiencing an immersive, calming nature-based environment (e.g., underwater ocean scenes, forest walks) |
| control | Active comparator | Procedure: standard sedationPatients will receive standard regional anesthesia with routine institutional sedation protocols (e.g., midazolam, fentanyl) without any VR intervention. They will wear an opaque eye mask to maintain blinding |
Who may qualify
- Ages
- 45 months to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for elective cemented or uncemented hip arthroplasty under regional (spinal or epidural) anesthesia.
- ASA physical status I-III.
- Mentally capable of providing informed consent.
Key exclusion criteria (5 listed)
- Pre-existing cognitive impairment or dementia (as assessed by the Mini-Mental State Examination).
- Severe uncorrected visual or hearing impairments that prevent VR device tolerance.
- Severe psychiatric disorders (e.g., schizophrenia, bipolar disorder).
- General contraindications to regional anesthesia (e.g., localized back infection, severe coagulopathy).
- Inability to physically tolerate or adjust to the VR headset
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 |
|---|---|---|
| immersive virtual realityA VR headset will be placed on the patient's head 5 minutes before the administration of spinal anesthesia. Throughout the intraoperative procedure under regional anesthesia, the patient will experience an immersive, calming, nature-based VR environment (such as underwater ocean scenes or forest walks) via specialized sights and sounds. This acts as a non-pharmacological distraction technique to reduce intraoperative anxiety and subsequently alleviate postoperative emergence agitation | Device | VR |
| standard sedationPatients will undergo standard preparation and management for elective hip arthroplasty under regional anesthesia. The intraoperative phase will follow routine institutional sedation and analgesia protocols using conventional pharmacological agents (e.g., midazolam, fentanyl) titrated based on standard clinical needs. To ensure robust triple-blinding, patients in this group will wear an opaque eye mask during the procedure to match the physical presence of a headset. | Procedure or surgery | control |
Primary outcome
Postoperative Agitation
Time frame: From the immediate arrival at the post-anesthesia care unit (PACU) up to 6 hours postoperatively.
Postoperative emergence agitation will be assessed using the unabbreviated Riker Sedation-Agitation Scale (SAS). The score ranges from a minimum value of 1 (unarousable) to a maximum value of 7 (dangerous agitation). A score of 4 indicates a calm and cooperative patient, while scores from 5 to 7 indicate increasing levels of agitation (higher scores mean worse agitation outcomes
Intraoperative Anxiety
Time frame: badeline (Pre-procedure), intraoperatively (every 1 hour), andat 1 hour post-operative
Intraoperative anxiety and sedation levels will be evaluated using the unabbreviated Ramsay Sedation Scale (RSS). The score ranges from a minimum value of 1 (patient anxious and agitated or restless) to a maximum value of 6 (patient asleep with no response). Lower scores indicate higher anxiety and agitation levels, while higher scores indicate deeper sedation and better anxiety control.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing immersive virtual reality and standard sedation in people with Hip Osteoarthritis and Hip Arthroplasty Replacement, run by Menoufia University.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Saieed Mansour, M.D. (00201225484055, dr.mostafa_s_fahim@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Agitation (time frame: From the immediate arrival at the post-anesthesia care unit (PACU) up to 6 hours postoperatively.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2026.