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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01901445
Other study ID # CAAE-0039.0.447.000-11
Secondary ID
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 ClĂ­nicas 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


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
See also
  Status Clinical Trial Phase
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Recruiting NCT03018613 - Fecal Microbiota Transplantation for Chronic Functional Constipation Phase 1/Phase 2
Recruiting NCT06364111 - Comparative Study on the Efficacy of Vibrabot Capsule and Polyethylene Glycol for Chronic Functional Constipation N/A
Completed NCT02751411 - Effectiveness & Safety of Promelaxin® Microenemas Against Macrogol 4000 P.O. in Chronic Constipation in Children 6-48 Months Phase 4