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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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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
What is being tested?
immersive virtual reality and standard sedation
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

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.

Mostafa Saieed Mansour, M.D. contact

00201225484055

dr.mostafa_s_fahim@yahoo.com

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.

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 groups in NCT07705451
Study groupRoleWhat they receive
VRExperimentalPatients 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
controlActive comparatorPatients 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.

  1. 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.

  2. 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.

  1. First posted15 Jul 2026
  2. Study start10 Jul 2026 (estimated)
  3. Primary completion20 Aug 2026 (estimated)
  4. Study completion15 Sep 2026 (estimated)

Resources

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)
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

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