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

NCT04041180 | Completed

• 1 other identifier: CHRO-2018-04
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Pediatric

Keywords

Sickle cell disease; incentive spirometry; pain; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (1)

CHR d'Orleans

Orléans, 45067, France

Location

Related Publications (1)

• 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.

  PMID: 7637747 RESULT

Related Links

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

MeSH Terms

Conditions

Anemia, Sickle Cell; Pain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandrine Sandrine PELLETIER

  CHR d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: August 1, 2019
• Study Start: November 6, 2018
• Primary Completion: April 6, 2019
• Study Completion: April 6, 2019
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

FR (1)