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

Sponsor

Centre Hospitalier Régional d'Orléans (Other)

Overall Status

Completed

CT.gov ID

NCT04041180

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sickle Cell Disease Pediatric

Study Design

Study Type:

Observational

Actual Enrollment :

25 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 6, 2018

Actual Primary Completion Date :

Apr 6, 2019

Actual Study Completion Date :

Apr 6, 2019

Outcome Measures

Primary Outcome Measures

Number of day staying in the pediatric ward according to the maximal inspiratory capacities during incentive spirometry sessions. [throught study completion, an overage of 24hours]

Secondary Outcome Measures

Correlation between pain level and maximal inspiratory capacity during incentive spirometry sessions. [throught study completion, an overage of 24hours]
Correlation between the maximum inspiratory volume achieved during incentive spirometry and children's mobility (attitude and mobility items according to the EVENDOL scale). [throught study completion, an overage of 24hours]
Correlation between the use of analgesic strategies and the inspiratory volume related to patients' size and age [throught study completion, an overage of 24hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHR d'Orleans	Orléans		France	45067

Sponsors and Collaborators

Centre Hospitalier Régional d'Orléans

Investigators

Principal Investigator: Sandrine Sandrine PELLETIER, CHR d'Orléans

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.

Responsible Party:

Centre Hospitalier Régional d'Orléans

ClinicalTrials.gov Identifier:

NCT04041180

Other Study ID Numbers:

CHRO-2018-04

First Posted:

Aug 1, 2019

Last Update Posted:

Aug 1, 2019

Last Verified:

Jul 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Régional d'Orléans

Additional relevant MeSH terms:

Anemia, Sickle Cell

Study Results

No Results Posted as of Aug 1, 2019