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

NCT ID: NCT06917300

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-16
• Study Completion Date: 2026-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Virtual Reality (VR) Group - Hospital Environment Exposure

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.

Group Type: EXPERIMENTAL

Virtual Reality

Intervention Type: 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 - Nature Scenery Exposure

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

Group Type: ACTIVE_COMPARATOR

Virtual Reality

Intervention Type: 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.

Standard Care (Control) Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Lodz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Redwan Rahman Jabbar

Lodz, Łódź Voivodeship, Poland

Site Status: RECRUITING

Countries

Poland

Central Contacts

Redwan Jabbar, MD, PhD (Candid.)

Role: CONTACT

rredwanbakal@gmail.com

0048570940828

Facility Contacts

Redwan Jabbar, MD, PhD (Candid.)

Role: primary

rredwanbakal@gmail.com

0048570940828

Other Identifiers

RNN/02/24/KE

Identifier Type: -

Identifier Source: org_study_id