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

NCT03674346 | Unknown DMC

• 1 other identifier: 69HCL17_0044
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Angioma

Keywords

hypnoanalgesia; cutaneous angioma; sclerosis treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Patient anxiety score assessed by anxiety Visual Analog Scale (EVA)

  Day 0

• number of side effects

  Day 0

• gravity of side effects

  Day 0

• Patient satisfaction assessed by a satisfaction questionary

  Day 0

• Pain assessed by Visual Analog Scale (EVA)

  Day 0

Study Arms (2)

Hypnoanalgesia group

EXPERIMENTAL

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

MEOPA Group

OTHER

The pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA)

Other: Meopa Group

Interventions

Hypnoanalgesia group OTHER

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.

Hypnoanalgesia group

Meopa Group OTHER

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.

MEOPA Group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Femme Mère Enfant

Bron, France

Location

MeSH Terms

Conditions

Hemangioma

Condition Hierarchy (Ancestors)

Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Claire BENOIT-RUBY

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claire BENOIT-RUBY

CONTACT

474855098; claire.benoit-ruby@chu-lyon.fr

Adeline Mansuy

CONTACT

472115170; adeline.mansuy@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 17, 2018
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: October 19, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)