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NCT Number: NCT07103096

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rheumatology department Hôpital Saint Antoine

Paris, 75012, France

Location status: Recruiting

Location contact

Alice COURTIES, Medical doctor

CONTACT

[email protected]

+33 (0)1 49 28 25 20

About this study

The performance of infiltrative procedures in rheumatology is common, even daily, practice. It may be associated with anticipatory anxiety and pain (for example, during a shoulder infiltration, there is a significant difference between anticipated pain and pain felt with a visual analogue scale of 6.03 versus 3.17, P < 0.001) as well as pain and anxiety during the procedure. Certain techniques are used to limit this anxiety and pain in common practice such as explaining the procedure before and during its performance, the atmosphere (particularly musical atmosphere) and decoration of the room where the procedure takes place (relaxing images visible to the patient, brightness, people present) and the attitude of the practitioner. More recently, hypnosis and/or 3D virtual reality techniques using a virtual reality headset have been implemented in medicine and particularly in rheumatology to help manage chronic or acute pain. Thus, we currently use a virtual reality headset associated with hypnotic induction (using an audio headset) for the performance of many infiltrative procedures. However, there is no data concerning the acceptability and satisfaction of the patient and the physician of the addition of this technique (VR headset with hypnotic induction) nor its feasibility in current practice (extension of the procedure time for example), during an infiltration nor to know if these data can vary according to the infiltrated location.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

    Time frame: day one

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

Secondary outcomes

  1. To assess investigator satisfaction

    Time frame: Day one

    Number of times the doctor is satisfied according to the 5-point Likert scale of satisfaction. Minimum value: 0= not satisfied. Maximum value= 5 totally satisfied. Higher score mean better outcome.

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

    Time frame: Day one

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

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

    Time frame: day one

    Numerical scale patient anxiety during infiltration: mean (standard deviation). Minimum value: 0= Not at all anxious. Maximum value= 10 very anxious. Higher score mean worse outcome.

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

    Time frame: day one

    Patient pain numerical scale during infiltration: mean (standard deviation) Minimum value: 0= no pain. Maximum value= 10 the worst pain imaginable. Higher score mean worse outcome.

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

    Time frame: day one

    • Numerical scale of pain during infiltration Minimum value: 0= no pain. Maximum value= 10 the worst pain imaginable. Higher score mean worse outcome.
    • Numerical scale of anticipated pain of infiltration. Minimum value: 0= no anticipated pain. Maximum value= 10 the worst anticipated pain imaginable. Higher score mean worse outcome.
  6. Evaluate the added duration of the gesture by using the virtual reality headset

    Time frame: day one

    Duration of the gesture in minutes

  7. Compare the duration of the gesture with hypnotic 3D virtual reality versus the assumed duration without the use of the headset

    Time frame: day one

    Average added time by the Virtual Reality headset according to the doctor

  8. Describe the tolerance of the Virtual Reality headset

    Time frame: day one

    Proportion of immediate side effects to the virtual reality headset

Study contacts

Contact information is provided by the study sponsor or research team.

Alice COURTIES, Medical doctor

CONTACT

[email protected]

+33 (0)1 49 28 25 20

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Infiltration in Rheumatology With 3D Virtual Reality Headset Pilot Study for the Evaluation of Satisfaction and Feasibility According to Location (Icare)

Acronym: Icare

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2025
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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