Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04041180
Recruitment Status : Completed
First Posted : August 1, 2019
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional d'Orléans

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Sickle Cell Disease Pediatric

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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 : November 6, 2018
Actual Primary Completion Date : April 6, 2019
Actual Study Completion Date : April 6, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
sickle cell children admitted to the paediatric department at the CHR of Orléans
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04041180


Locations
Layout table for location information
France
CHR d'Orleans
Orléans, France, 45067
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
Investigators
Layout table for investigator information
Principal Investigator: Sandrine Sandrine PELLETIER CHR d'Orléans
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications of Results:

Layout table for additonal information
Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT04041180    
Other Study ID Numbers: CHRO-2018-04
First Posted: August 1, 2019    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional d'Orléans:
Sickle cell disease
incentive spirometry
pain
children
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn