Back to resultsPhysiotherapy Efficiency on Child Asthma
Primary Purpose
Child, Asthma Crisis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
usual treatment
usual treatment + sophrology
Sponsored by
About this trial
This is an interventional other trial for Child
Eligibility Criteria
Inclusion Criteria:
- child (6 to 17 years old)
- hospitalized in pediatric unit for asthma crisis
Exclusion Criteria:
- patient who can't participate because of his healthcare (resuscitation...)
- impossibility to measure Peak Expiratory Flow (PEF)
Sites / Locations
- Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
usual treatment
usual treatment + sophrology
Arm Description
usual treatment
usual treatment + sophrology
Outcomes
Primary Outcome Measures
Peak Expiratory Flow (PEF)
Secondary Outcome Measures
Full Information
NCT ID
NCT02114398
First Posted
February 26, 2014
Last Updated
September 18, 2018
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02114398
Brief Title
Physiotherapy Efficiency on Child Asthma
Official Title
Physiotherapy Efficiency With Caycedian Sophrology on Child Asthma: Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aim is to compare usual asthma crisis treatment of hospitalized children with usual treatment associated to sophrology.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child, Asthma Crisis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
usual treatment
Arm Type
Experimental
Arm Description
usual treatment
Arm Title
usual treatment + sophrology
Arm Type
Experimental
Arm Description
usual treatment + sophrology
Intervention Type
Other
Intervention Name(s)
usual treatment
Intervention Description
usual treatment
Intervention Type
Other
Intervention Name(s)
usual treatment + sophrology
Intervention Description
usual treatment + sophrology
Primary Outcome Measure Information:
Title
Peak Expiratory Flow (PEF)
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
child (6 to 17 years old)
hospitalized in pediatric unit for asthma crisis
Exclusion Criteria:
patient who can't participate because of his healthcare (resuscitation...)
impossibility to measure Peak Expiratory Flow (PEF)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal AMEDRO, MD, PhD
Organizational Affiliation
UH Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
29493875
Citation
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.
Results Reference
result
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Physiotherapy Efficiency on Child Asthma
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