3D virtual reality headset to improve comfort during rheumatology infiltrations
Infiltration in Rheumatology With 3D Virtual Reality Headset Pilot Study for the Evaluation of Satisfaction and Feasibility According to Location (Icare)
Assistance Publique - Hôpitaux de Paris · NCT07103096
This will test whether using a 3D virtual reality headset with hypnotic audio makes infiltrations more comfortable and satisfying for adult rheumatology patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT07103096 on ClinicalTrials.gov |
What this trial studies
Rheumatology infiltrations are common and can cause anticipatory anxiety and pain, and virtual reality combined with hypnotic audio may help distract or relax patients. This observational pilot will use a 3D VR headset with hypnotic induction during infiltrations at different anatomical sites and record patient and physician satisfaction along with feasibility metrics such as procedure duration and acceptability. Adult patients undergoing spine, subacromial-deltoid bursa, or knee infiltrations at Hôpital Saint-Antoine will be enrolled, with exclusions for epilepsy, severe psychiatric disorders, sensory or cognitive impairments, recent similar infiltrations, prior VR use, or legal guardianship. The study will compare satisfaction and practical feasibility across infiltration locations.
Who should consider this trial
Good fit: Adults (18+) at Hôpital Saint-Antoine requiring spinal, subacromial-deltoid bursa, or knee infiltrations who do not have epilepsy, severe psychiatric or cognitive disorders, major sensory loss, recent similar infiltrations, prior VR headset use, or legal guardianship are ideal candidates.
Not a fit: Patients with epilepsy, severe psychiatric illness, major vision or hearing loss, cognitive impairment, recent similar infiltrations (<6 months), prior VR headset use, or under guardianship are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the approach could reduce anxiety and perceived pain during infiltrations and improve patient satisfaction with the procedure.
How similar studies have performed: Virtual reality and hypnotic techniques have reduced acute and chronic pain in other medical contexts, but specific data on acceptability, satisfaction, and feasibility for rheumatology infiltrations by location are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Patient requiring infiltration of the spine (high epidural or sacrococcygeal hiatus) of the subacromial-deltoid bursa or the knee, regardless of the product infiltrated * Within the Rheumatology department of Saint-Antoine hospital (consultation or hospitalized) Exclusion Criteria: * History of severe psychiatric disorders - History of epilepsy * Cognitive disorders * Language barrier - Hearing aid-assisted deafness and/or ophthalmological problems leading to a major loss of vision (advanced cataract, visual impairment) * Infiltration of the spine (high epidural or sacrococcygeal hiatus), subacromial-deltoid bursa or knee \< 6 months * Characterized depressive disorder diagnosed recently (for less than 6 months) or not stabilized * Previous use of a virtual reality headset during treatment * Being under guardianship or curatorship
Where this trial is running
Paris
- Rheumatology department Hôpital Saint Antoine — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Alice COURTIES, Medical doctor — APHP
- Study coordinator: Alice COURTIES, Medical doctor
- Email: alice.courties@ahp.fr
- Phone: +33 (0)1 49 28 25 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infiltration, infiltration, 3D virtual reality headset