Clinical trial NCT03674346: Efficacy of Hypnoanalgesia by a Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology
Official title: Efficacy of Hypnoanalgesia by a Radiological Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Angioma
Keywords: hypnoanalgesia
cutaneous angioma
sclerosis treatment
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 138
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: assessment of pain score by Visual Analog Scale (EVA)
timeFrame: Day 0
Secondary outcomes:
measure: Patient anxiety score assessed by anxiety Visual Analog Scale (EVA)
timeFrame: Day 0
measure: number of side effects
timeFrame: Day 0
measure: gravity of side effects
timeFrame: Day 0
measure: Patient satisfaction assessed by a satisfaction questionary
timeFrame: Day 0
measure: Pain assessed by Visual Analog Scale (EVA)
timeFrame: Day 0
measure: anxiety assessed by Visual Analog Scale (EVA)
timeFrame: Day 0
measure: number of injections performed per site
timeFrame: Day 0
measure: MEOPA administration time
timeFrame: Day 0
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: Claire BENOIT-RUBY
role: PRINCIPAL_INVESTIGATOR
References: