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

July 13, 2013 updated by: Gabriela Cunha Schechtman Sette, Universidade Federal de Pernambuco
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

11

Phase

  • Not Applicable

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

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50670-901
        • Recruiting
        • Universidade Federal de Pernambuco
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gabriela CS Sette, MSc
        • Sub-Investigator:
          • Maria Eugenia FA Motta, PhD
        • Sub-Investigator:
          • Luciane S Lima, PhD

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

6 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Educational action group
Behavioral: Educational action with focal group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The improvement in the quality of life on participants after the intervention
Time Frame: 3 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The improvement in clinical parameters of chronic functional constipation
Time Frame: 3 months
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

Collaborators and Investigators

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

Sponsor

Universidade Federal de Pernambuco

Investigators

  • Principal Investigator: Gabriela CS Sette, MSc, Universidade Federal de Pernambuco

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

May 1, 2013

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

May 25, 2013

First Submitted That Met QC Criteria

July 13, 2013

First Posted (Estimate)

July 17, 2013

Study Record Updates

Last Update Posted (Estimate)

July 17, 2013

Last Update Submitted That Met QC Criteria

July 13, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE-0039.0.447.000-11

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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