Parental Mental Health After Tracheostomy in Early Childhood

Anxiety of Parents Clinical Trial

— TRACH  

Official title:

Post-hospital Evaluation of Anxiety / Depression in Parents of Children Who Required Tracheostomy Before the Age of 1 Year

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02884570
• Other study ID #: 9253
• Status: Completed
• Start date: April 2014
• Est. completion date: July 17, 2019

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the prevalence of anxiety / depression in post- hospital for parents (mothers and fathers) of children with tracheotomy before the age of 1 year between 2000 and 2012.

Description:

The goal of this study is to evaluate the level of anxiety / depression of families and to correlate to the lived parental of tracheotomy and indirectly that of the child (hetero - evaluation).

The information from this study should allow staff to refine and adjust their practices in terms of information and support for families with tracheotomised children. The information given to families before the establishment of a tracheotomy for their child may also be adapted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 17, 2019
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion criteria :

Families whose child :

• Has been tracheotomised before the age of 1 year between 2000 and 2012

• Came out of hospital with a tracheotomy tube

• Is or has been followed by one of three centers

Exclusion criteria :

• Children decannulated before hospital discharge .

• Death before the start of the study

Related Conditions & MeSH terms

• Anxiety Disorders
• Anxiety of Parents
• Depression
• Depression of Parents
• Depressive Disorder
• Tracheotomised Children

Intervention

Other:
• Auto-Questionnaires
Consents and questionnaires will be sent to the parental home or filled in an interview with an investigator (or telephone consultation).

Locations

Country	Name	City	State
France	University Hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety and Depression	Auto-questionnaire Hospital Anxiety and Depression Scale HADS	Through study completion, up to 6 months
Secondary	Experienced of the care by the families	Auto-questionnaire Hartnick	Through study completion, up to 6 months