Cystic fibrosis in children with chest physiotherapy prescription Respiratory Cystic fibrosis with pulmonary manifestations
Conditions
Interventions
This is a randomised control parallel trial involving children with cystic fibrosis from 2 to 17 years old treated at the Paediatric Pulmonology Unit at Malaga Regional Hospital with chest physiothera
Sponsors
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of cystic fibrosis based on international criteria 2. Children between ages of 2-17 3. Undergoing periodic clinic visits in the cystic fibrosis Unit 4. Understanding the purpose of the study 5. To provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Children without chest physiotherapy prescription 2. Children with severe hearing loss 3. Children at radiologic or clinical risk of pneumothorax or pneumomediastinum 4. Children with barotrauma in the month prior to entry in the study 5. Children with past history of massive or life-threatening haemoptysis 6. Transplant recipients or children awaiting a lung transplant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Children's and family members' enjoyment to chest physiotherapy is evaluated via questionnaire with a Likert scale (-3 to +3): least enjoyment – neutral - most enjoyment. The outcome will be measured at baseline and after 12 weeks. 2. Perception of time taken to complete the routine will be evaluated via questionnaires. Perceived time values given on the questionnaire will be subtracted from actual time values given. These differences will be calculated, and then analysed. The outcome will be measured at baseline and after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Chest physiotherapy characteristics are determined using questionnaires at baseline and after 6 and 12 weeks. 1.1. Characteristics are defined as activities used to accompany the routine, such as toys, stories, music, radio and TV. 2. Chest physiotherapy adherence is evaluated via questionnaires at baseline and after 6 and 12 weeks. 2.1. Adherence is defined as routine frequency, the number of times per day, interruptions, length per session. 3. Music characteristics are evaluated via a questionnaire after 12 weeks. 3.1. Music characteristics are defined as the music use frequency, response to the use of music during routine, usefulness of music during the routine, to continue using this music as an adjunct to the routine in the future. 4. The impact on the quality of life is evaluated via questionnaires at baseline and after 12 weeks. 5. Perception of pulmonary symptomatology is evaluated using a dyspnoea visual analogue scale (being 1 no dyspnoea and 7 maximal dyspnoea) at baseline and after 12 weeks. 6. Demographic (age, gender) and clinical information (number of respiratory infection exacerbations that requiring hospitalization and days of hospitalization) are completed by paediatricians during the usual follow-up. | — |
Countries
Spain
Outcome results
None listed