Tracheotomised ChildrenTRACHNCT02884570
Parental Mental Health After Tracheostomy in Early Childhood
An observational study of Tracheotomised Children and Anxiety of Parents, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tracheotomised Children, Anxiety of Parents, Depression of Parents
- What is being tested?
- Auto-Questionnaires
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to 17 Jul 2019
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Parents (mothers and fathers) of children with tracheotomy before the age of 1 year between 2000 and 2012. Pre- selection will take place in Pediatric Neonatal and Reanimation services of Montpellier, Paris (Hôpital Robert Debré ) and Strasbourg
Who may be able to join
- 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
Who cannot join
- Children decannulated before hospital discharge .
- Death before the start of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-hospital Evaluation of Anxiety / Depression in Parents of Children Who Required Tracheostomy Before the Age of 1 Year
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.
Read the detailed 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.
- Being tested
- Auto-Questionnaires
- Keywords
- Tracheotomy, Anxiety, Depression, Back Home
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auto-QuestionnairesOther
Consents and questionnaires will be sent to the parental home or filled in an interview with an investigator (or telephone consultation).
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and Depression
Auto-questionnaire Hospital Anxiety and Depression Scale HADS
Measured: Through study completion, up to 6 months
Secondary outcomes (1)
Experienced of the care by the families
Auto-questionnaire Hartnick
Measured: Through study completion, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startApr 2014
- Primary completionJul 2017
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheotomised ChildrenStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Cambonie, Professor, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884570
- Sponsor's protocol ID
- 9253
- Acronym
- TRACH
- Status last verified
- May 2024
- First submitted
- 4 Aug 2016
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-hospital Evaluation of Anxiety / Depression in Parents of Children Who Required Tracheostomy Before the Age of 1 Year
- ClinicalTrials.gov ID
- NCT02884570
- Acronym / sponsor ID
- TRACH / 9253
- Keywords
- Tracheotomy, Anxiety, Depression, Back Home
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 31 Aug 2016 (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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents (mothers and fathers) of children with tracheotomy before the age of 1 year between 2000 and 2012. Pre- selection will take place in Pediatric Neonatal and Reanimation services of Montpellier, Paris (Hôpital Robert Debré ) and Strasbourg
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Children decannulated before hospital discharge .
- Death before the start of the study
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 |
|---|---|---|
| Auto-QuestionnairesConsents and questionnaires will be sent to the parental home or filled in an interview with an investigator (or telephone consultation). | Other | – |
Primary outcome
Anxiety and Depression
Time frame: Through study completion, up to 6 months
Auto-questionnaire Hospital Anxiety and Depression Scale HADS
1 secondary outcome
Experienced of the care by the families
Time frame: Through study completion, up to 6 months
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 29 May 2024.
- Individual participant dataSharing planned: Undecided
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.
Gilles Cambonie, Professor principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tracheotomised Children and Anxiety of Parents, 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 4 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 29 May 2024. 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?
Anxiety and Depression (time frame: Through study completion, up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2024.