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Clinical Trials in Poland / NCT06917300
Recruiting Not applicable

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

NCT06917300 · tracked via the Priya Life Science Poland tracker
Phase
Not applicable
Started
2024-08-16
Last updated
2025-04-08

Condition(s) studied

Anxiety and FearPain, PostoperativeStress

Investigational drug(s) / intervention(s)

Virtual Reality

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 using a Max 360 action VR camera. In the video, actors, neurosurgeons, and nurses will re-enact a typical day for a mock patient undergoing surgery, plus routine post-operative care, including the post-operative immediate recovery room and rehabilitation care by neurosurgeons, psychologists, and physiotherapists in the ward. Patients are allowed to move around freely so that they can experience all aspects of the virtual space, and are encouraged to ask questions at the end.

Study 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.

Eligibility

Sex
ALL
Min age
25 Years
Max age
70 Years
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Redwan Rahman Jabbar Lodz Łódź Voivodeship Recruiting

More Medical University of Lodz trials in Poland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06917300 on ClinicalTrials.gov ↗ ← All trials in Poland