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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Osteoarthritis; Hip Arthroplasty Replacement; Emergence Agitation; Postoperative Anxiety; Hip Fracture Surgeries; Emergence Delirium, Anesthesia
• Intervention / Treatment: Device: immersive virtual reality; Procedure: standard sedation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mostafa Saieed Mansour, M.D.; Phone Number: 00201225484055; Email: dr.mostafa_s_fahim@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR; 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; 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
Active Comparator: control; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): September 15, 2026

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Mental Disorders; Postoperative Complications; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Osteoarthritis; Delirium; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergence Delirium; Osteoarthritis, Hip
• Other Study ID Numbers: 4/2026ANET1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No