Contribution of an Educational Game for Continuous Positive Pressure/Non-invasive Ventilation Therapeutic Education in Children

Sleep Disordered Breathing Clinical Trial

— YAPOUNI  

Official title:

Contribution of an Educational Game for Continuous Positive Pressure/Non-invasive Ventilation Therapeutic Education in Children

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04660994
• Other study ID #: APHP200959
• Secondary ID: 2020-A01737-32
• Status: Withdrawn
• Start date: December 2020
• Est. completion date: January 2022

Study information

• Verified date: December 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Non-communicating child.
• Child with major cognitive impairment.
• Child / parents not speaking French.
• Child in an unstable clinical condition.

Related Conditions & MeSH terms

• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep Disordered Breathing

Intervention

Other:
• Educational game
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 game is explained at Necker Hospital during the therapy education for CPAP/NIV and used at home for 1 month.

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Parents'feelings	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.	Scale change from day 0 to day 30
Secondary	Feeling of children	Quantitative score of the questionnaire of feelings of the children about the CPAP/NIV initiation process.; Home made questionnaire of 5 questions with responses by visual analogue scale from 0 to 10; 0 is the worst feeling and 10 the best.	Scale change from day 0 to day 30
Secondary	Parents' concerns or difficulties	Score on the parental concerns and difficulties questionnaire regarding the health of their children.; Questionnaire of 6 questions of 7-level ordinal scale of answer; 0 is the worst feeling and 100 the best.	Scale change from day 0 to day 30
Secondary	Family impact	Pediatric Quality of Life Inventory, Parent-Proxy Report (PEDSQL) questionnaire on family impact of the child's illness (s) rated from 0 to 100, high results being associated with a better quality of life.	Change from day 0 to day 30
Secondary	Functioning of the child	Pediatric Quality of Life Inventory, Child-Self Report (PEDSQ) questionnaire on the child functioning rated from 0 to 100, high results being associated with a better quality of life.	Change from day 0 to day 30
Secondary	Therapeutic compliance in hours	Average number of hours of CPAP / NIV use per night.	Change from day 8 to day 30
Secondary	Therapeutic compliance in days	Average number of days of CPAP / NIV use.	Change from day 8 to day 30
Secondary	Motivation of parents	Parent motivation scale (adaptation of the situational motivation scale). Questionnaire of 9 questions of 7-level ordinal scale of answer ; 0 is the worst feeling and 100 the best.	Change from day 0 to day 30
Secondary	Motivation of children	Child motivation scale (adaptation of the situational motivation scale). Questionnaire of 3 questions with responses by visual analogue scale from 0 to 10; 0 is the worst score and 10 the highest motivation.	Change from day 0 to day 30
Secondary	Parents competence	Parents competence scale (adaptation of the perceived competence scale). Questionnaire of 4 questions of 5-level ordinal scale of answer; 0 is the worst feeling and 100 the best.	Change from day 0 to day 30
Secondary	Children competence	Children competence scale (adaptation of the perceived competence scale). Questionnaire of 2 questions with responses by visual analogue scale from 0 to 10; 0 is the worst score and 10 the highest competence feeling.	Change from day 0 to day 30
Secondary	Effect of the TEP session on healthcare professionals	Score at the questionnaire on the effect of the session on healthcare professionals.; Questionnaire of 5 questions of 7-level ordinal scale of answer, the higher the score, the more positive the feeling ; 0 is the worst feeling and 100 the best.	Change from day 0 to day 30
Secondary	Number of calls from parents	Number of calls from parents regarding to CPAP / NIV and Yapouni game.	Day 30
Secondary	Score on Yapouni questionnaire for parents	Parents' evaluation of the game. Questionnaire of 5 questions of 7-level ordinal scale of answer, the higher the score, the more positive the appreciation ; 0 is the worst feeling and 100 the best.	Change from day 8 to day 30
Secondary	Score on Yapouni questionnaire for children	Evaluation of the game by children. Questionnaire of 3 questions with responses by visual analogue scale from 0 to 10; 0 is the worst score and 10 the highest appreciation.	Change from day 8 to day 30
Secondary	Score on Yapouni questionnaire for healthcare professionals	Evaluation of the game by healthcare professionals. Questionnaire of 6 questions of 7-level ordinal scale of answer, the higher the score, the more positive the appreciation ; 0 is the worst feeling and 100 the best.	Change from day 8 to day 30