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

Medical University of Lodz

Status: Enrolling

Conditions: Anxiety and Fear; Pain, Postoperative; Stress

Treatments: Device: Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT06917300

RNN/02/24/KE

Details and patient eligibility

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Virtual Reality (VR) Group - Hospital Environment Exposure

Experimental group

Description:

This 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.

Treatment:

Device: Virtual Reality

Virtual Reality (VR) Group - Nature Scenery Exposure

Active Comparator group

Description:

Patients within this group will be provided with standard routine care followed by VR exposure to an immersive environment (i.e., natural scenery, urban parks, tropical beaches, forests) with background music using a commercially available application (i.e., Nature Treks) through a head-mounted display (HMD) and headsets

Treatment:

Device: Virtual Reality

Standard Care (Control) Group

No Intervention group

Description:

The standard group, in which patients will only receive standard care and be provided with routine descriptions of the pre-operative experience, where a surgeon will explain to them what the pre-operative experience would entail.