Efficacy of Hypnoanalgesia by a Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology (HYP-ANGE)

Efficacy of Hypnoanalgesia by a Radiological Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology

This study highlights the global management of the various components of outpatient pain by hypnoanalgesia (pain management by hypnosis) in radiopediatrics.

Indeed, pain is induced by sclerosis of cutaneous angiomas in interventional radiology. It is managed by MEOPA (an equimolar mixture of oxygen nitrous oxide) or by general anesthesia.

For four years, the medical electroradiology technologist of the Mother and Child Hospital (HFME) of the Hospices Civils de Lyon offer patients in addition a pain management by hypnoanalgesia.

The investigator propose a multicenter open randomized study comparing two pain management strategies, in children aged 7 to 18 years treated for cutaneous angioma by sclerosis in interventional radiology at the HFME. The two strategies studied are: Hypnoanalgesia and MEOPA (the reference strategy).

The main objective is to evaluate the efficacy of hypnoanalgesia compared to the standard of care of pain, which is the use of MEOPA, in the treatment of sclerosis of cutaneous angioma in pediatric interventional radiology.

Study Overview

• Status: Not yet recruiting
• Conditions: Angioma
• Intervention / Treatment: Other: Hypnoanalgesia group; Other: Meopa Group

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Claire BENOIT-RUBY; Phone Number: +33 474855098; Email: claire.benoit-ruby@chu-lyon.fr
• Study Contact Backup: Name: Adeline Mansuy; Phone Number: +33 472115170; Email: adeline.mansuy@chu-lyon.fr

Study Locations

• France
  • Bron, France
    • Hôpital Femme Mère Enfant
    • Contact: Claire BENOIT-RUBY; Email: claire.benoit-ruby@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Child requiring a first treatment with sclerosis cutaneous angioma whose location allows treatment in interventional radiology room,
• Child from 7 to 18 years old on the day of treatment,
• Free and informed consent of the child and his parents (or legal representative),
• Patient affiliated to a social security scheme

Exclusion Criteria:

• Child under tutorship or guardianship,
• Child suffering from severe psychotic disorders or under psychotropic drug treatment,
• Child who has already had angioma sclerosis in the interventional radiology room. Indeed, the child can remember a previous support and have a priori, positive or negative, on the new support (memory bias),
• Child not speaking French,
• Deaf child or hearing impaired not allowing easy listening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypnoanalgesia group; It is performed by a radiologist technologist who has been trained in Ericksonian hypnoanalgesia in the Hospices Civils de Lyon and has been practicing it regularly for 1 year.	Other: Hypnoanalgesia group; The running of a hypnosis session is protocolized and is based on three times: The hypnotic induction time that allows to move from the state of consciousness to a modified state of consciousness: it will be adapted according to the patient as specified by the procedure of Ericksonian hypnosis. It varies from a few seconds to 10 minutes. Induction time depends on the patient's level of stress, apprehension, subsequent experiences of hospitalization, history, and level of hypnotizability.; The dissociation time. It is the state of modified consciousness obtained at the end of the induction which is prolonged,; The time of "return". It is time that allows the patient to regain his classic state of consciousness.
Other: MEOPA Group; The pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA)	Other: Meopa Group; The pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA) throughout the procedure. For optimal use, the beginning of its administration by the radiological technologist is performed 3 minutes before the sclerosant injection (at the end of the locating ultrasound). The end of administration will correspond to the end of the injections of the sclerosing product. These sclerosing products are not considered experimental or ancillary products in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of pain score by Visual Analog Scale (EVA)	Comparison of the pain score felt by the child during the procedure (score 0 or 1, absence or presence of pain, on an Analog Visual Scale (EVA)) between the MEOPA group and the hypnoanalgesia group.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient anxiety score assessed by anxiety Visual Analog Scale (EVA)		Day 0
number of side effects	comparaison between groups.	Day 0
gravity of side effects	comparaison between groups.	Day 0
Patient satisfaction assessed by a satisfaction questionary		Day 0
Pain assessed by Visual Analog Scale (EVA)		Day 0
anxiety assessed by Visual Analog Scale (EVA)		Day 0
number of injections performed per site		Day 0
MEOPA administration time		Day 0

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Claire BENOIT-RUBY, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 14, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: hypnoanalgesia; cutaneous angioma; sclerosis treatment
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Sclerosis; Hemangioma
• Other Study ID Numbers: 69HCL17_0044

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