Virtual Reality as a Digital Premed to Alleviate Pain and Anxiety Preoperatively in Patients Undergoing Spine Surgery

Not Applicable

Recruiting

• Conditions: Anxiety and Fear; Pain, Postoperative; Stress

• Registration Number: NCT06917300
• Lead Sponsor: Medical University of Lodz

Brief Summary

The aim of this research study is to evaluate the impact of immersive VR exposure on preoperative anxiety and pain. Additionally, to assess whether VR intervention would significantly alleviate pain and anxiety levels of patients undergoing complex spinal surgeries. Investigators hypothesize that the application of pre-operative VR-based intervention will alleviate anxiety and pain both pre- and post-operatively when it is used as treatment to complement standard care compared to standard routine care alone, and that it may lead to better outcomes and higher satisfaction in patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-16
• Study First Submitted: 2025-02-16
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-31
• Last Update Submitted: 2025-03-31
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Primary Completion: 2025-09-15
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Adult patients between 25-70 years old, undergoing an elective spinal surgery.
• Patient's admission prior to surgery day (at least 1 day).
• Expected hospital stay - 2 days.
• Capable of providing informed consent and participate in the study follow-up questionnaire.
• Patients speak Polish.

Exclusion Criteria

• Congestive heart failure, hypertension and anti-hypertensive medications
• Adrenal insufficiency
• Alcohol addiction (evaluated by CAGE/AUDIT) and substance addiction (evaluated by DUDIT)
• Cognitive impairment (evaluated by MMSE, MoCA)
• Cerebrovascular diseases, ophthalmological diseases (strabismus, diplopia, retina degeneration, glaucoma), neurological conditions (epilepsy or seizure, dementia, vertigo, dizziness, motion sickness) - evaluated by: history taking, examination, vision test (Ishihara test), Simulator Sickness Questionnaire
• Auditory impairment
• Psychiatric illness (schizophrenia, bipolar disorder, psychotic depression) - (evaluated by MINI questionnaire)
• Patients with neuropathic pain
• Use of sedative drugs, anti-depressants, anxiolytics, and anti-epileptic drugs
• Intracranial functional lesions (patients after TBI (Traumatic Brain Injury), cognitive or executive dysfunction)
• Patient with high risk due to major and emergency operations
• Claustrophobia
• GCS < 15

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Stress (STAI-S) and Pain (VAS)	24 hours postoperatively	The Primary outcome for this trial is the change in the intensity of pre-operative anxiety measured by the State-Trait Anxiety Inventory (STA-I) scale and pain measured by visual Analogue Scale (VAS). These outcomes will be measured pre-operatively on the day before surgery. Measurements will be made again post-operatively - within 24 hours. Pre-operative and post-operative STAI-S and VAS will be compared for data analysis.

Secondary Outcome Measures

Name	Time	Method
Satisfaction (EVAN-G) and Postoperative Stress (PSS-10)	24 hours postoperatively	The Secondary outcome will be the patients' quality of life and satisfaction measured by Evaluation du Vecu de l'Anesthesie Generale (EVAN-G) questionnaire and postoperative stress measured by Perceived Stress Scale PSS-10 within 24 hours and used for data analysis, since the level of satisfaction and the stress caused by thinking time spent at pain can contribute to an increased perception of pain.

Trial Locations

Locations (1)

Redwan Rahman Jabbar; 🇵🇱 Łódź, Lodzkie, Poland