- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03674346
Efficacy of Hypnoanalgesia by a Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology (HYP-ANGE)
Efficacy of Hypnoanalgesia by a Radiological Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Claire BENOIT-RUBY
- Phone Number: +33 474855098
- Email: claire.benoit-ruby@chu-lyon.fr
Study Contact Backup
- Name: Adeline Mansuy
- Phone Number: +33 472115170
- Email: adeline.mansuy@chu-lyon.fr
Study Locations
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-
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Bron, France
- Hôpital Femme Mère Enfant
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Contact:
- Claire BENOIT-RUBY
- Email: claire.benoit-ruby@chu-lyon.fr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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The running of a hypnosis session is protocolized and is based on three times:
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Other: MEOPA Group
The pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA)
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
assessment of pain score by Visual Analog Scale (EVA)
Time Frame: Day 0
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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.
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Day 0
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient anxiety score assessed by anxiety Visual Analog Scale (EVA)
Time Frame: Day 0
|
Day 0
|
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number of side effects
Time Frame: Day 0
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comparaison between groups.
|
Day 0
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gravity of side effects
Time Frame: Day 0
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comparaison between groups.
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Day 0
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Patient satisfaction assessed by a satisfaction questionary
Time Frame: Day 0
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Day 0
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Pain assessed by Visual Analog Scale (EVA)
Time Frame: Day 0
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Day 0
|
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anxiety assessed by Visual Analog Scale (EVA)
Time Frame: Day 0
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Day 0
|
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number of injections performed per site
Time Frame: Day 0
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Day 0
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MEOPA administration time
Time Frame: Day 0
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Day 0
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Claire BENOIT-RUBY, Hospices Civils de Lyon
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 69HCL17_0044
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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