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

N/ANot Yet RecruitingNCT07705451

Menoufia University40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Hip Osteoarthritis Hip Arthroplasty Replacement Emergence Delirium, Anesthesia Emergence Agitation Hip Fracture Surgeries

Interventions

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

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.

Eligibility

Sex: ALLMin age: 45 MonthsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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.

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