NCT03674346|UnknownDMC
Efficacy of Hypnoanalgesia by a Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology
HYP-ANGE
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HYP-ANGE
Sponsor study identifier
interventional
138
1 country
1
Study Start
January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 14, 2018
Actual (reported)September 17, 2018
Actual (reported)January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Patient anxiety score assessed by anxiety Visual Analog Scale (EVA)
Day 0
number of side effects
Day 0
gravity of side effects
Day 0
Patient satisfaction assessed by a satisfaction questionary
Day 0
Pain assessed by Visual Analog Scale (EVA)
Day 0
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.
The pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA)
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.
Hôpital Femme Mère Enfant
Bron, France
Claire BENOIT-RUBY
Hospices Civils de Lyon
First Submitted
September 14, 2018
First Posted
September 17, 2018
Study Start
January 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2026
Estimated (date passed)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.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 19, 2023
Record last verified: 2023-10
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