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

July 31, 2019 updated by: Centre Hospitalier Régional d'Orléans

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Orléans, France, 45067
        • CHR d'Orléans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

sickle cell children admitted to the paediatric department at the CHR of Orléans

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
throught study completion, an overage of 24hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between pain level and maximal inspiratory capacity during incentive spirometry sessions.
Time Frame: throught study completion, an overage of 24hours
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).
Time Frame: throught study completion, an overage of 24hours
throught study completion, an overage of 24hours
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
throught study completion, an overage of 24hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Régional d'Orléans

Investigators

  • Principal Investigator: Sandrine Sandrine PELLETIER, CHR d'Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2018

Primary Completion (Actual)

April 6, 2019

Study Completion (Actual)

April 6, 2019

Study Registration Dates

First Submitted

February 4, 2019

First Submitted That Met QC Criteria

July 31, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

August 1, 2019

Last Update Submitted That Met QC Criteria

July 31, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHRO-2018-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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