Virtual Reality as a Digital Premed to Alleviate Pain and Anxiety Preoperatively in Patients Undergoing Spine Surgery
Recruiting · NCT06917300 · Interventional (participants receive a specific treatment) · Lead sponsor: Medical University of Lodz
View the official record on ClinicalTrials.gov →Interventions studied
Virtual Reality
What this trial is about
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.
Who can take part
Age range
25 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Redwan Rahman Jabbar - Lodz, Łódź Voivodeship, Poland