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

NCT06917300 | Recruiting

• 1 other identifier: RNN/02/24/KE
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Anxiety and Fear; Pain, Postoperative; Stress

Outcome Measures

Primary Outcomes (1)

• Stress (STAI-S) and Pain (VAS)

  The Primary outcome for this trial is the change in the intensity of pre-operative anxiety measured by the State-Trait Anxiety Inventory (STA-I) scale and pain measured by visual Analogue Scale (VAS). These outcomes will be measured pre-operatively on the day before surgery. Measurements will be made again post-operatively - within 24 hours. Pre-operative and post-operative STAI-S and VAS will be compared for data analysis.

  24 hours postoperatively

Secondary Outcomes (1)

• Satisfaction (EVAN-G) and Postoperative Stress (PSS-10)

  24 hours postoperatively

Study Arms (3)

Virtual Reality (VR) Group - Hospital Environment Exposure

EXPERIMENTAL

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.

Device: Virtual Reality

Virtual Reality (VR) Group - Nature Scenery Exposure

ACTIVE COMPARATOR

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

Device: Virtual Reality

Standard Care (Control) Group

NO INTERVENTION

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.

Interventions

Virtual Reality DEVICE

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.

Virtual Reality (VR) Group - Hospital Environment Exposure; Virtual Reality (VR) Group - Nature Scenery Exposure

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Redwan Rahman Jabbar

Lodz, Łódź Voivodeship, 90-549, Poland

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Pain, Postoperative

Condition Hierarchy (Ancestors)

Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Redwan Jabbar, MD, PhD (Candid.)

CONTACT

0048570940828; rredwanbakal@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: April 8, 2025
• Study Start: August 16, 2024
• Primary Completion: September 15, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-03

Locations

PL (1)