AngiomaHYP-ANGENCT03674346
Efficacy of Hypnoanalgesia by a Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology
A study testing Hypnoanalgesia group and Meopa Group in people with Angioma, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Angioma
- What is being tested?
- Hypnoanalgesia group and Meopa Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Femme Mère Enfant
Bron
Claire BENOIT-RUBY, claire.benoit-ruby@chu-lyon.fr
About this study
Official title: 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.
Read more
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.
- Conditions
- Angioma
- Being tested
- Hypnoanalgesia group, Meopa Group
- Keywords
- hypnoanalgesia, cutaneous angioma, sclerosis treatment
- Medical subject headings
- Hemangioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnoanalgesia groupOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Hypnoanalgesia group |
| MEOPA Group | Other | The pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA) Receives: Other: Meopa Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (8)
Patient anxiety score assessed by anxiety Visual Analog Scale (EVA)
Measured: Day 0
number of side effects
comparaison between groups.
Measured: Day 0
gravity of side effects
comparaison between groups.
Measured: Day 0
Patient satisfaction assessed by a satisfaction questionary
Measured: Day 0
Pain assessed by Visual Analog Scale (EVA)
Measured: Day 0
anxiety assessed by Visual Analog Scale (EVA)
Measured: Day 0
number of injections performed per site
Measured: Day 0
MEOPA administration time
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study startJan 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AngiomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire BENOIT-RUBY, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674346
- Sponsor's protocol ID
- 69HCL17_0044
- Acronym
- HYP-ANGE
- Status last verified
- Oct 2023
- First submitted
- 14 Sep 2018
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hypnoanalgesia by a Radiological Radiologist Technologist in Children With Cutaneous Angioma Treated With Sclerosis in Interventional Radiology
- ClinicalTrials.gov ID
- NCT03674346
- Acronym / sponsor ID
- HYP-ANGE / 69HCL17_0044
- Conditions
- Angioma
- Keywords
- hypnoanalgesia, cutaneous angioma, sclerosis treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnoanalgesia group | Experimental | Other: Hypnoanalgesia groupIt 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 | Other: Meopa GroupThe pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA) |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnoanalgesia groupThe 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. | Other | Hypnoanalgesia group |
| Meopa GroupThe 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. | Other | MEOPA Group |
Primary outcome
assessment of pain score by Visual Analog Scale (EVA)
Time frame: Day 0
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.
8 secondary outcomes
Patient anxiety score assessed by anxiety Visual Analog Scale (EVA)
Time frame: Day 0
number of side effects
Time frame: Day 0
gravity of side effects
Time frame: Day 0
Patient satisfaction assessed by a satisfaction questionary
Time frame: Day 0
Pain assessed by Visual Analog Scale (EVA)
Time frame: Day 0
anxiety assessed by Visual Analog Scale (EVA)
Time frame: Day 0
number of injections performed per site
Time frame: Day 0
MEOPA administration time
Time frame: Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire BENOIT-RUBY principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnoanalgesia group and Meopa Group in people with Angioma, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire BENOIT-RUBY (474855098 ext. +33, claire.benoit-ruby@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of pain score by Visual Analog Scale (EVA) (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.