Clinical trial NCT04041180: Impact on the Length of Stay in Incentive Spirometry and Pain in the Decompensation of Sickle Cell Disease: .
Official title: Incentive Spirometry and Pain in the Decompensation of Sickle Cell Disease: Impact on the Length of Stay. Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Pediatric
Keywords: Sickle cell disease
incentive spirometry
pain
children
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
First posted: 2019-08-01
Enrollment: 25
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: sickle cell children admitted to the paediatric department at the CHR of Orléans

Brief summary: In this prospective observational study among sickle cell children aged 7 to 17 years, who face many experience of pain, pain will be assessed during incentive spirometry sessions. Then a relation between, inspiratory volume, pain and the length of hospital stay will be identified .

Currently, there is no scientific data regarding the correlation between acute pain during vaso-occlusive crisis, incentive spirometry and the impact on length of hospital stay. In fact, physiotherapist experience's in the pediatric department suggests that the pain expressed by the child is not always correlated with inspiratory capacity.

The absence of pain is one of the reasons for hospital discharge after decompensation in patients with sickle cell disease. However, no scientific study has linked incentive spirometry, pain and length of hospital stay.

Investigator assume that these children underestimate the real pain and its impact on breathing pattern, and presume that the maximal inspiratory volume during spirometry sessions will be a better reflect of pain than standard pain scale.

The aim of this study is to show that inspiratory volume would be a better indicator of discharge from hospitalization than actual pain scales.


Eligibility criteria: Inclusion Criteria:

* Sickle cell children aged 7 to 17 admitted to the pediatric ward
* Children receiving respiratory physiotherapy sessions under medical prescription
* Children hospitalized for more than 24 hours at the CHRO and benefiting from more than one physiotherapy session.
* Absence of opposition of one of the parents to the participation of their child in the study
* Absence of opposition of children able to understand the study

Non inclusion Criteria:

* Sickle cell children under the age of 7 or over 17
* Children with mental deficits
* Non-French-speaking parents
* Children receiving only one physiotherapy session and being hospitalized within 24 hours

Primary outcomes:
measure: Number of day staying in the pediatric ward according to the maximal inspiratory capacities during incentive spirometry sessions.
timeFrame: throught study completion, an overage of 24hours
Secondary outcomes:
measure: Correlation between pain level and maximal inspiratory capacity during incentive spirometry sessions.
timeFrame: throught study completion, an overage of 24hours
measure: Correlation between the maximum inspiratory volume achieved during incentive spirometry and children's mobility (attitude and mobility items according to the EVENDOL scale).
timeFrame: throught study completion, an overage of 24hours
measure: Correlation between the use of analgesic strategies and the inspiratory volume related to patients' size and age
timeFrame: throught study completion, an overage of 24hours
Other outcomes:
Locations:
city: Orléans
country: France
facility: CHR d'Orleans
Study officials:
affiliation: CHR d'Orléans
name: Sandrine Sandrine PELLETIER
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bellet PS, Kalinyak KA, Shukla R, Gelfand MJ, Rucknagel DL. Incentive spirometry to prevent acute pulmonary complications in sickle cell diseases. N Engl J Med. 1995 Sep 14;333(11):699-703. doi: 10.1056/NEJM199509143331104.