Contribution of an Educational Game for Continuous Positive Pressure/Non-invasive Ventilation Therapeutic Education in Children
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Parents'feelings
研究概览
简要总结
A growing number of children with obstructive sleep apnea syndrome (OSAS) or nocturnal alveolar hypoventilation syndrome are treated with continuous positive airway pressure (CPAP) or nocturnal non-invasive ventilation (NIV) therapy.
The compliance of the child and his caregivers with CPAP / NIV therapy may be challenging.
The use of an educational game (Yapouni) aims at improving communication around CPAP / NIV between the child and his caregivers, and may facilitate the compliance with CPAP / NIV at home, by increasing the motivation for using CPAP / NIV at home.
The aim of the study is to assess the parents' feelings regarding the use of CPAP / NIV on day 0 (D0) and one month (D30) later in a standard group: therapeutic education (TEP) versus a group: TEP + Yapouni.
详细描述
The study concerns children with severe obstructive sleep apnea syndrome and / or alveolar hypoventilation requiring the initiation of CPAP/NIV. Most of these children have associated diseases (craniofacial malformations, trisomy 21, Prader Willi syndrome or neuromuscular diseases) which are accompanied by an abnormality of nocturnal breathing causing abnormalities in gas exchange and abnormalities of architecture and quality of sleep, with deleterious consequences on neurocognitive, cardiovascular and metabolic functions. In the absence of other treatments, the initiation of CPAP or NIV during sleep can correct the respiratory anomalies and the deleterious consequences. Optimal compliance with treatment is therefore essential for its efficacy and therapeutic education (TEP) plays a key role.
The compliance of the child and his caregivers with CPAP / NIV therapy may be challenging.
The use of an educational game (Yapouni) aims at improving communication around CPAP / NIV between the child and his caregivers, and may facilitate the compliance with CPAP / NIV at home, by increasing the motivation for using CPAP / NIV at home.
The Yapouni educational game is based on a hot air balloon that will fly according to the number of hours the child has slept with his/her CPAP / NIV. Thus, the longer the child sleeps with his/her CPAP / NIV, the farther and higher his/her hot air balloon will fly in the sky. The game includes wild cards and rewards that are worked out with the child and his/her parents for an optimal individualized adaptation.
The aim of the study is to assess the parents' feelings regarding the use of CPAP / NIV on D0 and D30 later in a standard group: therapeutic education (TEP) versus a group: TEP + Yapouni.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 3 to 16 years old with severe obstructive sleep apnea syndrome and / or alveolar hypoventilation requiring the initiation of a treatment with CPAP / NIV in the pediatric non-invasive ventilation and sleep unit of Necker-Enfants Malades hospital.
- •Child's caregivers not opposing to the patient's participation in research.
排除标准
- •Non-communicating child.
- •Child with major cognitive impairment.
- •Child / parents not speaking French.
- •Child in an unstable clinical condition.
研究组 & 干预措施
Therapeutic education
Children with disordered breathing requiring CPAP or NIV and followed-up by the pediatric non-invasive ventilation and sleep unit of Necker-Enfants Malades hospital.
Therapeutic education and Yapouni educational game
Children with disordered breathing requiring CPAP or NIV and followed-up by the pediatric non-invasive ventilation and sleep unit of Necker-Enfants Malades hospital.
干预措施: Educational game (Other)
结局指标
主要结局
Parents'feelings
时间窗: Scale change from day 0 to day 30
Quantitative score at the parental feelings questionnaire about the CPAP/NIV initiation process. Home made questionnaire of 5 questions with responses by visual analogue scale from 0 to 100; 0 is the worst feeling and 100 the best.
次要结局
- Motivation of parents(Change from day 0 to day 30)
- Score on Yapouni questionnaire for healthcare professionals(Change from day 8 to day 30)
- Motivation of children(Change from day 0 to day 30)
- Effect of the TEP session on healthcare professionals(Change from day 0 to day 30)
- Score on Yapouni questionnaire for parents(Change from day 8 to day 30)
- Feeling of children(Scale change from day 0 to day 30)
- Parents' concerns or difficulties(Scale change from day 0 to day 30)
- Functioning of the child(Change from day 0 to day 30)
- Therapeutic compliance in hours(Change from day 8 to day 30)
- Family impact(Change from day 0 to day 30)
- Therapeutic compliance in days(Change from day 8 to day 30)
- Parents competence(Change from day 0 to day 30)
- Children competence(Change from day 0 to day 30)
- Number of calls from parents(Day 30)
- Score on Yapouni questionnaire for children(Change from day 8 to day 30)