Interest of Virtual Reality Headset During Injection in Patients With Back Pain and Sciatica

NCT05505968 | Completed

• 1 other identifier: PO22085*
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

For a few years, publications have been published concerning the use of virtual reality headsets in the field of medicine and particularly in various specialities. It has been evaluated in different studies on pain and anxiety in various medical situations. A study has shown a correlation between a decrease in pain in a clinical way during a painful stimulation and a decrease in certain areas of the brain. In this context, the use of the virtual reality headset could then be used in medical interventions that may be painful for the patient. The lumbar radicular pain is a common disease in the world. The epidural injection is one of the treatment of this pathology. He may be performed to reduce the pain but sometimes this act is painful. Most of the time this procedure is performed without premedication. To the knowledge of the investigators, there are currently no studies on the assessment of pain under a virtual reality headset during the performance of an epidural injection in rheumatology. The aim of the study is to demonstrate that the Virtual Reality Headset can reduce the pain and the anxiety during an epidural injection.

Conditions

Lumbar Radicular Pain

Outcome Measures

Primary Outcomes (2)

• State-Trait Anxiety Inventory

  State-Trait Anxiety Inventory STAI-B (trait anxiety), STAI-A (state anxiety)

  Day 1

• State-Trait Anxiety Inventory

  STAI-B (trait anxiety), STAI-A (state anxiety)

  Day 3

Study Arms (2)

virtual reality - Day1

EXPERIMENTAL

Use of the virtual reality headset during the first epidural infiltration (Day 1). The second infiltration (Day 3) will be performed without the virtual reality headset.

Other: Virtual Reality Headset

virtual reality - Day3

EXPERIMENTAL

First epidural infiltration without the virtual reality headset (day 1). The second infiltration will be performed with the virtual reality headset (Day 3).

Other: Virtual Reality Headset

Interventions

Virtual Reality Headset OTHER

Virtual Reality Headset of the society Healthy Mind and is a CE Class 1 medical device. This virtual reality headset is a Pico G2 4K and corresponds to the model A7510 and is connected to a Bose Sound Link 2 AE headset.

Also known as: Medical device

virtual reality - Day1; virtual reality - Day3

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged 18-90 years,
• Diagnosed with lomboradiculalgia requiring two epidural injection through the sacrococcygeal hiatus,
• Hospitalized in the Rheumatology Department of the University Hospital of Reims,
• Speak French language.
• Affiliated or beneficiary of a social security scheme
• Having given their written agreement to participate in the study (signature of the consent form)

You may not qualify if:

• Profound or total deafness,
• Visually impaired,
• Presence of contraindication to injection,
• Inability to answer the questionnaire due to severe cognitive impairment,
• Injection with and without virtual reality headset not performed by the same person,
• Vestibular pathologies,
• Epilepsy,
• Claustrophobia,
• Use of nitrous oxide for injection.
• Premedication for infiltration (analgesic, anxiolytic)
• Patients under guardianship, curatorship, safeguard of justice
• Pregnant women
• Psychotic disorders

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Related Publications (1)

• Javelot M, Chopin C, Bolko L, Hittinger A, Geoffroy M, Charlot I, Adeline F, Coutureau C, Duvivier A, Salmon JH. Effect of Virtual Reality on Pain and Anxiety During Epidural Steroid Injection in Patients with Lumbar Radicular Pain: An Open-Label Randomized Trial. Healthcare (Basel). 2025 Sep 22;13(18):2376. doi: 10.3390/healthcare13182376.

  PMID: 41008506 RESULT

MeSH Terms

Interventions

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 18, 2022
• Study Start: August 8, 2022
• Primary Completion: February 22, 2023
• Study Completion: January 12, 2024
• Last Updated: January 21, 2026

Record last verified: 2024-01

Locations

FR (1)