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

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.

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Key information

Conditions

Hip Osteoarthritis Arthritis Confusion Delirium Emergence Agitation Emergence Delirium Emergence Delirium, Anesthesia Hip Arthroplasty Replacement Hip Fracture Surgeries Joint Diseases Mental Disorders Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Osteoarthritis Osteoarthritis, Hip Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Anxiety Postoperative Complications Rheumatic Diseases Signs and Symptoms

Age range

45 month–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mostafa Saieed Mansour, M.D.

CONTACT

[email protected]

00201225484055

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

Effect of Using Virtual Reality on Intraoperative Anxiolysis and Postoperative Agitation in Older Patients Undergoing Hip Arthroplasty Under Regional Anesthesia

Acronym: VR

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jul 15, 2026
Registry last updated: Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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