Actively Recruiting

Phase Not Applicable
Age: 25Years - 70Years
All Genders
ID06917300

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

Led by Medical University of Lodz · Updated on 2025-04-08

150

Participants Needed

1

Research Sites

54 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating the use of immersive virtual reality (VR) to reduce preoperative anxiety and pain in adults undergoing elective spinal surgery. This study aims to determine if a VR-based intervention before surgery can better manage anxiety and pain compared to standard care alone, potentially leading to improved patient outcomes and satisfaction. The trial is randomized and includes adult patients aged 25 to 70 years undergoing spinal surgery. Participants are assigned to one of three groups: a VR group exposed to a 15-minute immersive 360° video simulating the pre- and post-operative experience using VR devices and goggles; a VR group experiencing calming natural scenery through a commercially available VR application; or a standard care group receiving routine preoperative explanations from a surgeon without VR exposure. The VR experiences include audio-visual environments designed to familiarize patients with surgery procedures and recovery. During the study, participants will be assessed for stress and pain levels 24 hours after surgery using standardized tools. Satisfaction and postoperative stress will also be measured at the same time point. Patients will complete follow-up questionnaires, and researchers will monitor their hospital stay and recovery. The total participation includes admission at least one day before surgery and an expected hospital stay of two days. The study includes careful screening to ensure participants meet criteria and excludes those with certain medical or psychiatric conditions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 25Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients between 25 and 70 years old undergoing elective spinal surgery
  • Admission at least one day before surgery
  • Expected hospital stay of two days
  • Ability to provide informed consent and participate in follow-up questionnaires
  • Ability to speak Polish
Not Eligible

You will not qualify if you...

  • Congestive heart failure, hypertension, or use of anti-hypertensive medications
  • Adrenal insufficiency
  • Alcohol or substance addiction
  • Cognitive impairment assessed by MMSE or MoCA
  • Cerebrovascular, ophthalmological, or neurological diseases such as epilepsy, seizure, dementia, vertigo, dizziness, or motion sickness
  • Auditory impairment
  • Psychiatric illnesses including schizophrenia, bipolar disorder, or psychotic depression
  • Neuropathic pain
  • Use of sedative drugs, anti-depressants, anxiolytics, or anti-epileptic drugs
  • Intracranial functional lesions or history of traumatic brain injury
  • High risk due to major or emergency operations
  • Claustrophobia
  • Glasgow Coma Scale score less than 15

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of surgery

Participants undergo virtual reality exposure as a digital premedication to help alleviate pain and anxiety before spine surgery. This includes watching a 15-minute immersive VR video describing the pre-operative and post-operative experience on the day of surgery using VR devices and goggles.

1 visit (in-person)

Post-operative Follow-up

Duration - 24 hours postoperatively

Participants are assessed for stress, pain, and satisfaction following surgery, including questionnaires conducted 24 hours postoperatively.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Redwan Rahman Jabbar

Lodz, Łódź Voivodeship, Poland, 90-549

Actively Recruiting

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Research Team

R

Redwan Jabbar, MD, PhD (Candid.)

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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