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

Not Applicable

Not yet recruiting

• Conditions: Angioma
• Interventions: Other: Hypnoanalgesia group; Other: Meopa Group

• Registration Number: NCT03674346
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-14
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-17
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Study Start: 2024-01
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 138

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypnoanalgesia group	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.
MEOPA Group	Meopa Group	The pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA)

Primary Outcome Measures

Name	Time	Method
assessment of pain score by Visual Analog Scale (EVA)	Day 0	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.

Secondary Outcome Measures

Name	Time	Method
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
MEOPA administration time	Day 0
Patient anxiety score assessed by anxiety Visual Analog Scale (EVA)	Day 0
number of side effects	Day 0	comparaison between groups.
gravity of side effects	Day 0	comparaison between groups.
number of injections performed per site	Day 0

Trial Locations

Locations (1)

Hôpital Femme Mère Enfant; 🇫🇷 Bron, France