Infiltration in Rheumatology With 3D Virtual Reality Headset Pilot Study for the Evaluation of Satisfaction (ICARE)

NCT07103096 | Recruiting

• 2 other identifiers: APHP250404IDRCB 2025-A00458-41
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the satisfaction and feasibility according to the location of the use of a 3D virtual reality headset during an infiltration in rheumatology.

Conditions

Infiltration

Keywords

infiltration; 3D virtual reality headset

Outcome Measures

Primary Outcomes (1)

• To assess patient satisfaction with the use of 3D virtual reality with hypnotic induction during infiltration using Modified Client satisfaction score (CSQ-8)

  Modified Client satisfaction score (CSQ-8) Minimum value: 0= not satisfied. Maximum value= 4 totally satisfied. Higher score mean better outcome.

  day one

Secondary Outcomes (8)

• To assess investigator satisfaction

  Day one

• To Modified Client satisfaction score (CSQ-8) score according to the location of the infiltration

  Day one

• Assess the patient's anxiety during infiltration using a numerical scale

  day one

• To Assess the patient's pain during the infiltration using a numerical scale.

  day one

• To Compare pain during infiltration to anticipated pain from infiltration using a numerical scale

  day one

Study Arms (1)

Infiltration

Patient requiring infiltration of the spine (high epidural or sacrococcygeal hiatus) of the subacromial-deltoid bursa or the knee

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient requiring infiltration of the spine (high epidural or sacrococcygeal hiatus) of the subacromial-deltoid bursa or the knee

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Rheumatology department Hôpital Saint Antoine

Paris, 75012, France

RECRUITING

Study Officials

• Alice COURTIES, Medical doctor

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alice COURTIES, Medical doctor

CONTACT

+33 (0)1 49 28 25 20; alice.courties@ahp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: August 5, 2025
• Study Start: May 28, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)