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Questionnaire study to investigate the preference of children, parents and healthcare professionals for acceptability of different oral drug formulations

Conditions
As this is only a questionnaire response, patients can have any medical conditions. Parents and medical staff are interviewed regardless of illness.
Registration Number
DRKS00027640
Lead Sponsor
Klinik für Allgemeine Pädiatrie, Neonatologie und Kinderkardiologie, Universitätsklinik Düsseldorf
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
240
Inclusion Criteria

1. Age
Children aged 6-<12y and adolescents 12-<18y, parents of children aged 0-<18 y.
2. Sex
For children aged 6-<18y, 50% male and 50% female have to be included.
3. Health
Parents of all children are approached independent from health status. Children aged 6-<18y must be able to read and understand the questionnaires.
4. Compliance
Participants, participants’ parents, nurses, and paediatricians understand and are willing, able, and likely to comply with the survey procedures.
5. Consent
Participant, participant’s parents, nurses and paediatricians are capable of understanding the survey procedures and have indicated their consent with a cross on the questionnaire.
6. Affiliation
Children who participate in the study and children whose parents participate in the study must be patients at the Department of General Paediatrics, Neonatology and Paediatric Cardiology of the University Hospital Düsseldorf.
Nurses and paediatricians must be employees of the Department of General Paediatrics, Neonatology and Paediatric Cardiology of the University Hospital Düsseldorf.

Exclusion Criteria

1. Disease/Illness
Children aged 6-<18y that are unable to understand and read the questionnaire on their own (e.g., due to cerebral palsy), as assessed by the Investigator.
2. Intervention
2.1. Children in the post-operative period who are not yet fully awoke
2.2. Children that are not fully oriented for whatever reason
2.3. Children 6-<18 years of age, parents, nurses, and paediatricians not willing to complete the respective questionnaire

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To identify the best accepted oral formulation rated by children 6-<12y, and adolescents 12-<18y.<br><br>To identify the best accepted oral formulation rated by parents of children 0-<2y, and 2-<6y.
Secondary Outcome Measures
NameTimeMethod
- To identify the best accepted oral formulation rated by parents of the children 6-<12y, 12-<18y<br>- To identify the oral formulation considered best for different age groups by nurses<br>- To identify the oral formulation considered best for different age groups by paediatricians<br>- To investigate the percentage of participation refusals per cohort
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