Virtual Reality as a Digital Premed to Alleviate Pain and Anxiety Preoperatively in Patients Undergoing Spine Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Medical University of Lodz
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Stress (STAI-S) and Pain (VAS)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Virtual Reality (VR) Group - Hospital Environment Exposure
This VR group will be exposed to a unified 15-minute VR video via phone using a VR device and goggles after receiving routine standard care. A 360˚ video with an immersive audio-visual environment describing pre-operative and post-operative experience on the day of the surgery will be provided, by which they can get accustomed to the environment and procedures associated with the surgery.
Intervention: Virtual Reality (Device)
Virtual Reality (VR) Group - Nature Scenery Exposure
Patients within this group will be provided with standard routine care followed by VR exposure to an immersive environment (i.e., natural scenery, urban parks, tropical beaches, forests) with background music using a commercially available application (i.e., Nature Treks) through a head-mounted display (HMD) and headsets
Intervention: Virtual Reality (Device)
Standard Care (Control) Group
The standard group, in which patients will only receive standard care and be provided with routine descriptions of the pre-operative experience, where a surgeon will explain to them what the pre-operative experience would entail.
Outcomes
Primary Outcomes
Stress (STAI-S) and Pain (VAS)
Time Frame: 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 Outcomes
- Satisfaction (EVAN-G) and Postoperative Stress (PSS-10)(24 hours postoperatively)