Virtual Reality as a Digital Premed to Alleviate Pain and Anxiety Preoperatively in Patients Undergoing Spine Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality.
- Who it may be relevant to
- Registry conditions: Anxiety and Fear, Pain, Postoperative, Stress. Basic parameters: 25 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Virtual Reality
The 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. Background audio will be provided through headsets, and the video will be directed by a neurosurgeon filmed u
Primary outcome measures
- Stress (STAI-S) and Pain (VAS) [Time frame: 24 hours postoperatively]
Secondary outcome measures (1)
- Satisfaction (EVAN-G) and Postoperative Stress (PSS-10) [Time frame: 24 hours postoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Poland · 1 center
- Redwan Rahman Jabbar — Lodz
Identifiers
NCT: NCT06917300 · RNN/02/24/KE