Status:
RECRUITING
Virtual Reality as a Digital Premed to Alleviate Pain and Anxiety Preoperatively in Patients Undergoing Spine Surgery
Lead Sponsor:
Medical University of Lodz
Conditions:
Anxiety and Fear
Pain, Postoperative
Eligibility:
All Genders
25-70 years
Phase:
NA
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06917300
Start Date
August 16 2024
End Date
September 30 2026
Last Update
April 8 2025
Active Locations (1)
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1
Redwan Rahman Jabbar
Lodz, Łódź Voivodeship, Poland, 90-549