ChildNCT02114398
Physiotherapy Efficiency on Child Asthma
A study testing usual treatment and usual treatment + sophrology in people with Child and Asthma Crisis, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The study aim is to compare usual asthma crisis treatment of hospitalized children with usual treatment associated to sophrology. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Child, Asthma Crisis
- What is being tested?
- usual treatment and usual treatment + sophrology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Apr 2016
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- child (6 to 17 years old)
- hospitalized in pediatric unit for asthma crisis
Who cannot join
- patient who can't participate because of his healthcare (resuscitation...)
- impossibility to measure Peak Expiratory Flow (PEF)
Trial locations and contacts
1 site in 1 country.
France1 site
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Montpellier, 34295
About this study
Official title: Physiotherapy Efficiency With Caycedian Sophrology on Child Asthma: Randomized, Controlled Study
The study aim is to compare usual asthma crisis treatment of hospitalized children with usual treatment associated to sophrology.
- Conditions
- Child, Asthma Crisis
- Being tested
- usual treatment, usual treatment + sophrology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual treatmentOther
usual treatment
usual treatment + sophrologyOther
usual treatment + sophrology
| Study group | Role | What they receive |
|---|---|---|
| usual treatment | Experimental | usual treatment Receives: Other: usual treatment |
| usual treatment + sophrology | Experimental | usual treatment + sophrology Receives: Other: usual treatment + sophrology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Expiratory Flow (PEF)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startOct 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ChildStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal AMEDRO, MD, PhD, Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114398
- Sponsor's protocol ID
- 9162
- Status last verified
- Sep 2018
- First submitted
- 26 Feb 2014
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Romieu H, Charbonnier F, Janka D, Douillard A, Macioce V, Lavastre K, Abassi H, Renoux MC, Mura T, Amedro P. Efficiency of physiotherapy with Caycedian Sophrology on children with asthma: A randomized controlled trial. Pediatr Pulmonol. 2018 May;53(5):559-566. doi: 10.1002/ppul.23982. Epub 2018 Mar 1.
PubMed 29493875
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy Efficiency With Caycedian Sophrology on Child Asthma: Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT02114398
- Acronym / sponsor ID
- 9162
- Conditions
- Child, Asthma Crisis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Apr 2014 (estimated)
- 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.
The study aim is to compare usual asthma crisis treatment of hospitalized children with usual treatment associated to sophrology.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| usual treatment | Experimental | Other: usual treatmentusual treatment |
| usual treatment + sophrology | Experimental | Other: usual treatment + sophrologyusual treatment + sophrology |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- child (6 to 17 years old)
- hospitalized in pediatric unit for asthma crisis
Key exclusion criteria (2 listed)
- patient who can't participate because of his healthcare (resuscitation...)
- impossibility to measure Peak Expiratory Flow (PEF)
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 |
|---|---|---|
| usual treatmentusual treatment | Other | usual treatment |
| usual treatment + sophrologyusual treatment + sophrology | Other | usual treatment + sophrology |
Primary outcome
Peak Expiratory Flow (PEF)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2018.
- Results publication: PubMed 29493875Romieu H, Charbonnier F, Janka D, Douillard A, Macioce V, Lavastre K, Abassi H, Renoux MC, Mura T, Amedro P. Efficiency of physiotherapy with Caycedian Sophrology on children with asthma: A randomized controlled trial. Pediatr Pulmonol. 2018 May;53(5):559-566. doi: 10.1002/ppul.23982. Epub 2018 Mar 1.
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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.
Pascal AMEDRO, MD, PhD principal investigator
UH Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing usual treatment and usual treatment + sophrology in people with Child and Asthma Crisis, run by University Hospital, Montpellier 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 20 Sep 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Expiratory Flow (PEF) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02114398, which also lists 1 linked publication.
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 20 Sep 2018.