Back to resultsQuality of Life in Children and Adolescents With Chronic Functional Constipation: Educational Action Effects
Primary Purpose
Chronic Functional Constipation
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Educational action with focal group
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Functional Constipation focused on measuring Quality of life, Constipation, Focus groups, Health education, Problem-based learning
Eligibility Criteria
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
Sites / Locations
- Universidade Federal de PernambucoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Educational action group
Control group
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01901445
First Posted
May 25, 2013
Last Updated
July 13, 2013
Sponsor
Universidade Federal de Pernambuco
1. Study Identification
Unique Protocol Identification Number
NCT01901445
Brief Title
Quality of Life in Children and Adolescents With Chronic Functional Constipation: Educational Action Effects
Official Title
Quality of Life in Children and Adolescents With Chronic Functional Constipation: Educational Action Effects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed Description
The present research will be conducted on the specific constipation clinic in Hospital das Clínicas at Universidade Federal de Pernambuco.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Functional Constipation
Keywords
Quality of life, Constipation, Focus groups, Health education, Problem-based learning
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Educational action group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Educational action with focal group
Primary Outcome Measure Information:
Title
The improvement in the quality of life on participants after the intervention
Description
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).
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The improvement in clinical parameters of chronic functional constipation
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriela CS Sette, MSc
Phone
+55-81-8714-1679
Email
gabrielacssette@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriela CS Sette, MSc
Organizational Affiliation
Universidade Federal de Pernambuco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Pernambuco
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50670-901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela CS Sette, MSc
Phone
+55-81-8714-1679
Email
gabrielacssette@gmail.com
First Name & Middle Initial & Last Name & Degree
Maria Eugenia FA Motta, PhD
Phone
+55-81-8868-0555
Email
eugenia.motta@gmail.com
First Name & Middle Initial & Last Name & Degree
Gabriela CS Sette, MSc
First Name & Middle Initial & Last Name & Degree
Maria Eugenia FA Motta, PhD
First Name & Middle Initial & Last Name & Degree
Luciane S Lima, PhD
12. IPD Sharing Statement
Learn more about this trial
Quality of Life in Children and Adolescents With Chronic Functional Constipation: Educational Action Effects
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