NCT04328623

Brief Summary

Ultrasound-guided infiltration is a common procedure and is known to be locally painful. This care-induced pain leads to strong apprehension in patients who need to benefit from this procedure. The practice of hypnosis to improve the patient's comfort during a treatment has appeared progressively in hospital departments. Among the various existing conversational hypnosis techniques, there is the "magic glove" technique. This is the technique that will be used in this study. The investigators wish to evaluate the interest of hypnosis on the pain felt by the patient when performing an echo-guided infiltration of the hand, one of the most painful extremities during infiltrations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

October 8, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 2, 2022

Completed
2 years until next milestone

Results Posted

Study results publicly available

August 15, 2024

Completed
Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

1.9 years

First QC Date

March 30, 2020

Results QC Date

June 15, 2023

Last Update Submit

November 27, 2025

Conditions

Hand Injuries

Outcome Measures

Primary Outcomes (1)

  • Evaluate the Pain Felt in Patients Who Have Benefited From a Hypnosis Session Before a Hand Infiltration Versus Hand Infiltration Without Hypnosis

    Analogical visual scale of pain (VAS) To 0mm (no pain) form 10 mm (maximum pain imaginable)

    5 minutes after ultrasound-guided infiltration of hand

Study Arms (2)

Infiltration

ACTIVE COMPARATOR

Ultrasound-guided hand infiltration

Procedure: Infiltration

Hypnosis

EXPERIMENTAL

Hypnosis before Ultrasound-guided hand infiltration

Procedure: HypnosisProcedure: Infiltration

Interventions

HypnosisPROCEDURE

conversational hypnosis technique call the "magic glove"

Hypnosis
InfiltrationPROCEDURE

Ultrasound-guided hand infiltration

HypnosisInfiltration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with an indication of a first hand infiltration under ultrasound examination
  • Major patient
  • Patient with capacity to understand the protocol and has given oral consent to participate in the research,
  • Patient with social security coverage.

You may not qualify if:

  • Patient having preventively applied a pain patch to the area to be infiltrated
  • Contraindication to infiltrations ( imbalanced diabetes, imbalanced,hypertension, ongoing infections).
  • Hearing impaired patient
  • Patient under guardianship/curtel
  • Minor
  • Pregnant woman
  • Patient participating in another intervention research protocol
  • Patient unable to follow the protocol as judged by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHD Vendée

La Roche-sur-Yon, France, France

Location

Related Publications (1)

  • Trojet-Bossard A, Dorion A, Planche L, Chollet C, Rabiller S, Cormier G. [Hypnotic pain management during ultrasound-guided infiltration of the hand]. Rev Infirm. 2023 Aug-Sep;72(293):42-44. doi: 10.1016/j.revinf.2023.07.012. Epub 2023 Aug 8. French.

    PMID: 37633694RESULT

MeSH Terms

Conditions

Hand Injuries

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Adeline TROJET-BOSSARD
Organization
Centre Hospitalier Départemental Vendée
adeline.trojet-bossard@ght85.fr
251446572

Study Officials

  • Adeline Trojet-Bossard

    CHD Vendée

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2020

First Posted

March 31, 2020

Study Start

October 8, 2020

Primary Completion

September 2, 2022

Study Completion

September 2, 2022

Last Updated

December 3, 2025

Results First Posted

August 15, 2024

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)