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

NCT03674346 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2023-10-19

No results posted yet for this study

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

Interventions

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) 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.

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Principal Investigators

  • Claire BENOIT-RUBY · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03674346 on ClinicalTrials.gov