Psychometric Evaluation of the IPPAQ in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain

Pain Clinical Trial

Official title:

Psychometric Evaluation of the Inpatient Pediatric Physical Activity Questionnaire (IPPAQ) in Pediatric Patients With Sickle Cell Disease Hospitalized With Vasoocclusive Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058473
• Other study ID #: CCMC IRB Number 09-115
• Status: Completed
• Phase: N/A
• First received: January 26, 2010
• Last updated: July 29, 2013
• Start date: January 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Connecticut Children's Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Historically, sickle cell disease has not been viewed in the chronic pain paradigm because of its recurrent nature. Patients with sickle cell disease may be hospitalized for extended periods of time. As the hospital stay progresses, patients with SCD pain are often observed by clinicians to have improvements in function in areas such as self-care, mobility, and recreation despite continued self-report of high pain scores. This pattern of functional improvement with continued report of high pain intensity scores is common in patients with recurrent and chronic pain. A functional assessment tool that can assess function in the acute inpatient setting is needed.

The purpose of this study is to evaluate the Inpatient Pediatric Physical Activity Questionnaire (IPPAQ), as a measure of daily function in children with sickle cell disease hospitalized with vasoocclusive pain.

Description:

Refer to Brief Summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 21 Years

Eligibility

Inclusion Criteria:

• Documented sickle cell disease

• Sudden onset of pain consistent with vasoocclusive episode at the time of hospitalization.

• Pain requiring hospitalization and placement on standard clinical guideline for management of acute pain in sickle cell disease during hospitalization

• Cognitive ability to report pain on a 0-10 Numerical Rating Scale (NRS)

• Parental/patient consent and child assent

Exclusion Criteria:

• Primary diagnosis other than vasoocclusive pain

• Concurrent Acute Chest Syndrome (ACS)

• Patient previously enrolled in this study

• Inability to understand English

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Pain
• Sickle Cell Disease

Locations

Country	Name	City	State
United States	Connecticut Children's Medical Center	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Connecticut Children's Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IPPAQ	This is a functional assessment tool for pediatric sickle cell patients that is admisistered once a day.	1 day	No