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Completed

NCT Number: NCT02693431

Impact of Art Therapy on Anxiety Identified During Hospitalizations Among Children With Cystic Fibrosis Aged 8 to 13

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Treatment and study plan

Non interventional study

Other

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.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: MUCO-ART

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Feb 26, 2016
Registry last updated
Jan 30, 2019

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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