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

Civil Hospices of Lyon

Status: Not yet enrolling

Conditions: Angioma

Treatments: Other: Hypnoanalgesia group; Other: Meopa Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03674346

69HCL17_0044

Details and patient eligibility

About

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.

Enrollment: 138 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Hypnoanalgesia group

Experimental group

Description:

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.

Treatment:

Other: Hypnoanalgesia group

MEOPA Group

Other group

Description:

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

Treatment:

Other: Meopa Group