Virtual Reality for Intraoperative Anxiolysis and Postoperative Agitation in Elderely Hip Arthroplasty Patients

NCT07705451 | Not Yet Recruiting DMC

• 1 other identifier: 4/2026ANET1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  badeline (Pre-procedure), intraoperatively (every 1 hour), andat 1 hour post-operative

Study Arms (2)

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)

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

Procedure: standard sedation

Interventions

immersive virtual reality DEVICE

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

VR

standard sedation PROCEDURE

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.

control

Eligibility Criteria

• Age: 45 Months - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Menoufia University: lead

MeSH Terms

Conditions

Osteoarthritis, Hip; Emergence Delirium

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Mostafa Saieed Mansour, M.D.

CONTACT

00201225484055; dr.mostafa_s_fahim@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 15, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share