Cystic FibrosisMUCO-ARTNCT02693431
Impact of Art Therapy on Anxiety Identified During Hospitalizations Among Children With Cystic Fibrosis Aged 8 to 13
An observational study of Cystic Fibrosis, run by Nantes University Hospital at 1 site in France.
Trial summary
Currently the management of cystic fibrosis (CF) patients is mainly based on symptomatic treatments. The arrival of children in day hospital, every 2 to 3 months, is for many of them and those around them, stressful, rarely expressed, but noticeable by the care team. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Non interventional Study
- How many people
- 23 participants
- Where
- 1 siteFrance
- Study dates
- 29 Jun 2016to 27 Nov 2018
- 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 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: 27 children (and their parents) aged 8 to 13 years in 2016 with cystic fibrosis followed at CRCM children Nantes.
Who may be able to join
- Children with CF aged 8 to 13 years as part of their monitoring at CRCM children of Nantes University Hospital
- Parents and children willing to participate in research
- Non inclusion Criteria:
- Emergency consultation
- Planned move
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Art Therapy on Anxiety Identified During the Quarterly Update of Hospitalizations Among Children With Cystic Fibrosis Aged 8 to 13 - Pilot Study
Currently the management of cystic fibrosis (CF) patients is mainly based on symptomatic treatments. The arrival of children in day hospital, every 2 to 3 months, is for many of them and those around them, stressful, rarely expressed, but noticeable by the care team. In line with the recommendations of the High Authority of Health, the multidisciplinary team of Resources and Skills Centre for Cystic Fibrosis (CRCM) Pediatric of Nantes University Hospital offers a therapeutic education program tailored to the needs of children with cystic fibrosis and their families . The aim is to support children and parents in the acquisition of self-care skills (knowledge and skills) and coping skills, such as managing stress and emotions . Our goal is to demonstrate that art therapy, mobilizing coping skills of the child, facilitates its expressive capabilities and reduces anxiety.
- Conditions
- Cystic Fibrosis
- Being tested
- Non interventional Study
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non interventional StudyOther
Parents and children will be informed at the inclusion visit (V0) that is a normal consultation under the care of the child.
The children included will be followed for 18 months with a maximum of 6 months without meeting art therapy sessions and 12 months with art therapy. The art therapy sessions will be scheduled during the usual consultations conducted as part of the care of children.
At each visit, clinical, paraclinical and external factors of anxiety will be collected and anxiety of parents and children will be measured using specific questionnaires.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the overall score of children's anxiety after 4 visits including art therapy sessions compared to basal mean level of the first two visits without art therapy.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study start29 Jun 2016
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie DAVID, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693431
- Sponsor's protocol ID
- RC15_0459
- Acronym
- MUCO-ART
- Status last verified
- Jan 2019
- First submitted
- 17 Feb 2016
- Last updated
- 30 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Art Therapy on Anxiety Identified During the Quarterly Update of Hospitalizations Among Children With Cystic Fibrosis Aged 8 to 13 - Pilot Study
- ClinicalTrials.gov ID
- NCT02693431
- Acronym / sponsor ID
- MUCO-ART / RC15_0459
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 29 Jun 2016 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 26 Feb 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.
Currently the management of cystic fibrosis (CF) patients is mainly based on symptomatic treatments. The arrival of children in day hospital, every 2 to 3 months, is for many of them and those around them, stressful, rarely expressed, but noticeable by the care team. In line with the recommendations of the High Authority of Health, the multidisciplinary team of Resources and Skills Centre for Cystic Fibrosis (CRCM) Pediatric of Nantes University Hospital offers a therapeutic education program tailored to the needs of children with cystic fibrosis and their families . The aim is to support children and parents in the acquisition of self-care skills (knowledge and skills) and coping skills, such as managing stress and emotions . Our goal is to demonstrate that art therapy, mobilizing coping skills of the child, facilitates its expressive capabilities and reduces anxiety.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 27 children (and their parents) aged 8 to 13 years in 2016 with cystic fibrosis followed at CRCM children Nantes.
Key inclusion criteria (5 listed)
- Children with CF aged 8 to 13 years as part of their monitoring at CRCM children of Nantes University Hospital
- Parents and children willing to participate in research
- Emergency consultation
- Planned move
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Non interventional StudyParents and children will be informed at the inclusion visit (V0) that is a normal consultation under the care of the child. The children included will be followed for 18 months with a maximum of 6 months without meeting art therapy sessions and 12 months with art therapy. The art therapy sessions will be scheduled during the usual consultations conducted as part of the care of children. At each visit, clinical, paraclinical and external factors of anxiety will be collected and anxiety of parents and children will be measured using specific questionnaires. | Other | – |
Primary outcome
Changes in the overall score of children's anxiety after 4 visits including art therapy sessions compared to basal mean level of the first two visits without art therapy.
Time frame: Up to 18 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 30 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Valérie DAVID, Dr principal investigator
Nantes University Hospital
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 Cystic Fibrosis, run by Nantes University Hospital 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 5 inclusion and 0 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 30 Jan 2019. 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?
Changes in the overall score of children's anxiety after 4 visits including art therapy sessions compared to basal mean level of the first two visits without art therapy. (time frame: Up to 18 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 30 Jan 2019.