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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| MEOPA Group | Other | The pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnoanalgesia group | Other | The running of a hypnosis session is protocolized and is based on three times:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient anxiety score assessed by anxiety Visual Analog Scale (EVA) | Day 0 | |
| number of side effects | comparaison between groups. | Day 0 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire BENOIT-RUBY | Contact | 474855098 | +33 | claire.benoit-ruby@chu-lyon.fr |
| Adeline Mansuy | Contact | 472115170 | +33 | adeline.mansuy@chu-lyon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Claire BENOIT-RUBY | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Femme Mère Enfant | Bron | France |
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| ID | Term |
|---|---|
| D006391 | Hemangioma |
| ID | Term |
|---|---|
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| 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. |
|
| gravity of side effects |
comparaison between groups. |
| Day 0 |
| 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 |
| number of injections performed per site | Day 0 |
| MEOPA administration time | Day 0 |