NCT02114398

Brief Summary

The study aim is to compare usual asthma crisis treatment of hospitalized children with usual treatment associated to sophrology.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

September 20, 2018

Status Verified

September 1, 2018

Enrollment Period

2.5 years

First QC Date

February 26, 2014

Last Update Submit

September 18, 2018

Conditions

ChildAsthma Crisis

Outcome Measures

Primary Outcomes (1)

  • Peak Expiratory Flow (PEF)

    1 day

Study Arms (2)

usual treatment

EXPERIMENTAL

usual treatment

Other: usual treatment

usual treatment + sophrology

EXPERIMENTAL

usual treatment + sophrology

Other: usual treatment + sophrology

Interventions

usual treatmentOTHER

usual treatment

usual treatment
usual treatment + sophrologyOTHER

usual treatment + sophrology

usual treatment + sophrology

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • child (6 to 17 years old)
  • hospitalized in pediatric unit for asthma crisis

You may not qualify if:

  • patient who can't participate because of his healthcare (resuscitation...)
  • impossibility to measure Peak Expiratory Flow (PEF)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital

Montpellier, 34295, France

Location

Related Publications (1)

  • 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.

    PMID: 29493875RESULT

Study Officials

  • Pascal AMEDRO, MD, PhD

    UH Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2014

First Posted

April 15, 2014

Study Start

October 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

September 20, 2018

Record last verified: 2018-09

Locations

FR(1)