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Completed

NCT Number: NCT02884570

Parental Mental Health After Tracheostomy in Early Childhood

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.

Completed

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Key information

Conditions

Tracheotomised Children Anxiety Disorders Anxiety of Parents Behavior Behavioral Symptoms Depression Depression of Parents Mental Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Montpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auto-questionnaires

Other

Consents and questionnaires will be sent to the parental home or filled in an interview with an investigator (or telephone consultation).

Primary outcomes

  1. Anxiety and Depression

    Time frame: Through study completion, up to 6 months

    Auto-questionnaire Hospital Anxiety and Depression Scale HADS

Secondary outcomes

  1. Experienced of the care by the families

    Time frame: Through study completion, up to 6 months

    Auto-questionnaire Hartnick

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: TRACH

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Aug 31, 2016
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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