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Interest of Hypnosis on Pain Management During a Guided Echo Infiltration of the Hand (HYMN)

Primary Purpose

Hand Injuries

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Hypnosis

Infiltration

About this trial

This is an interventional supportive care trial for Hand Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

CHD Vendée

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Infiltration

Hypnosis

Arm Description

Ultrasound-guided hand infiltration

Hypnosis before Ultrasound-guided hand infiltration

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT04328623

First Posted

March 30, 2020

Last Updated

September 8, 2022

Sponsor

Centre Hospitalier Departemental Vendee

1. Study Identification

Unique Protocol Identification Number

NCT04328623

Brief Title

Interest of Hypnosis on Pain Management During a Guided Echo Infiltration of the Hand

Acronym

HYMN

Official Title

Interest of Hypnosis on Pain Management During a Guided Echo Infiltration of the Hand

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

October 8, 2020 (Actual)

Primary Completion Date

September 2, 2022 (Actual)

Study Completion Date

September 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Departemental Vendee

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hand Injuries

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Infiltration

Arm Type

Active Comparator

Arm Description

Ultrasound-guided hand infiltration

Arm Title

Hypnosis

Arm Type

Experimental

Arm Description

Hypnosis before Ultrasound-guided hand infiltration

Intervention Type

Procedure

Intervention Name(s)

Hypnosis

Intervention Description

conversational hypnosis technique call the "magic glove"

Intervention Type

Procedure

Intervention Name(s)

Infiltration

Intervention Description

Ultrasound-guided hand infiltration

Primary Outcome Measure Information:

Title

Evaluate the pain felt in patients who have benefited from a hypnosis session before a hand infiltration versus hand infiltration without hypnosis

Description

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

Time Frame

5 minutes after ultrasound-guided infiltration of hand

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adeline Trojet-Bossard

Organizational Affiliation

CHD Vendée

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHD Vendée

City

La Roche-sur-Yon

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Interest of Hypnosis on Pain Management During a Guided Echo Infiltration of the Hand

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