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

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.

Study Overview

• Status: Completed
• Conditions: Hand Injuries
• Intervention / Treatment: Procedure: Infiltration; Procedure: Hypnosis

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • La Roche-sur-Yon, France
    • CHD Vendée

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Infiltration; Ultrasound-guided hand infiltration	Procedure: Infiltration; Ultrasound-guided hand infiltration
EXPERIMENTAL: Hypnosis; Hypnosis before Ultrasound-guided hand infiltration	Procedure: Infiltration; Ultrasound-guided hand infiltration; Procedure: Hypnosis; conversational hypnosis technique call the "magic glove"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Departemental Vendee
• Investigators: Principal Investigator: Adeline Trojet-Bossard, CHD Vendée

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 8, 2020
• Primary Completion (ACTUAL): September 2, 2022
• Study Completion (ACTUAL): September 2, 2022

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (ACTUAL): March 31, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 8, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Hand Injuries
• Other Study ID Numbers: CHD 202-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No