RecruitingNot ApplicableNCT06917300

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

Sponsor

Medical University of Lodz

Enrollment

150 participants

Start Date

Aug 16, 2024

Study Type

INTERVENTIONAL

Conditions

Pain, Postoperative Stress Anxiety and Fear

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

Min Age: 25 YearsMax Age: 70 Years

Inclusion Criteria5

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 Criteria13

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

Interventions

DEVICEVirtual 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.