Quality of Life in Children and Adolescents With Chronic Functional Constipation: Educational Action Effects

Chronic Functional Constipation Clinical Trial

Official title:

Quality of Life in Children and Adolescents With Chronic Functional Constipation: Educational Action Effects

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01901445
• Other study ID #: CAAE-0039.0.447.000-11
• Status: Recruiting
• Phase: N/A
• First received: May 25, 2013
• Last updated: July 13, 2013
• Start date: May 2013
• Est. completion date: September 2013

Study information

• Verified date: July 2013
• Source: Universidade Federal de Pernambuco
• Contact: Gabriela CS Sette, MSc
• Phone: +55-81-8714-1679
• Email: gabrielacssette[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if the quality of life in children and adolescents diagnosed with chronic functional constipation improves after educational activity in focus group composed by these patients' mothers.

Description:

The present research will be conducted on the specific constipation clinic in Hospital das Clínicas at Universidade Federal de Pernambuco.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 19 Years

Eligibility

Inclusion Criteria:

• Children (6 to 9 years-old) and adolescents

• Diagnostic of chronic functional constipation

Exclusion Criteria:

• Patients using calcium and/or heme

• Patients with organic diseases that causes constipation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Functional Constipation
• Constipation

Intervention

Behavioral:
• Educational action with focal group

Locations

Country	Name	City	State
Brazil	Universidade Federal de Pernambuco	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The improvement in the quality of life on participants after the intervention	The quality of life outcomes will be assessed by using the Generic Core Questionnaires (Standard form) of Measurement Model for the Pediatric Quality of Life InventoryTM version (PedsQL) 4.0 Generic Core Scales (VARNI et al., 2001) was translated and validated in Brazil by Klatchoian et al. (2008).	3 months	No
Secondary	The improvement in clinical parameters of chronic functional constipation	The clinical parameters were assessed according to a specific questionnaire used on patient assistance at clinical hospital at UFPE. This questionnaire will be applied before and after the intervention.	3 months	No