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Completed

NCT Number: NCT04041180

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

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pediatric Signs and Symptoms

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHR d'Orleans

Orléans, 45067, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

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

Acronym: SPIDO

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 1, 2019
Registry last updated
Aug 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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