Impact on the Length of Stay in Incentive Spirometry and Pain in the Decompensation of Sickle Cell Disease: .

NCT ID: NCT04041180

Last Updated: 2019-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-06

Study Completion Date

2019-04-06

Brief Summary

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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.

Detailed Description

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Conditions

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Sickle Cell Disease Pediatric

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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


* 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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Régional d'Orléans

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandrine Sandrine PELLETIER

Role: PRINCIPAL_INVESTIGATOR

CHR d'Orléans

Locations

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CHR d'Orleans

Orléans, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 7637747 (View on PubMed)

Related Links

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http://linkinghub.elsevier.com/retrieve/pii/S0248866315600029

French guidelines for the management of adult sickle cell disease: 2015 update

Other Identifiers

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CHRO-2018-04

Identifier Type: -

Identifier Source: org_study_id

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