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

Angioma Clinical Trial

— HYP-ANGE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03674346
• Other study ID #: 69HCL17_0044
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: January 2026

Study information

• Verified date: October 2023
• Source: Hospices Civils de Lyon
• Contact: Claire BENOIT-RUBY
• Phone: 474855098
• Email: claire.benoit-ruby[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 138
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Angioma
• Hemangioma
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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