Emergence Agitation, Emergence Delirium, Anesthesia, Hip Arthroplasty Replacement, Hip Fracture Surgeries, Hip Osteoarthritis, Postoperative Anxiety
Conditions
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.
Interventions
DEVICEimmersive 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
PROCEDUREstandard 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.
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Months to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Agitation | 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 | 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. |
Contacts
CONTACTMostafa Saieed Mansour, M.D.
Outcome results
None listed