Constipation
Conditions
Interventions
We propose a clinical, longitudinal, cohort, prospective, uncontrolled clinical study whose data collection will occur in the 12-month period. The sample will be composed of 30 children, aged between
Modified Bristol scale for children (mBSFS-C) for analysis of
stool consistency
Intestine Function Index (BF-S)
Fecal continence index
PEDs 4.0 questionnaire for quality of life assessment
Questionnaire to evaluate the applicability of the sessions
the last 7 days.
Device
E02.331.800
C23.888.821.150
Sponsors
Universidade Estadual Paulista “Júlio de Mesquita Filho” Faculdade de Medicina de Botucatu-FMB/UNESP
Universidade Estadual Paulista “Júlio de Mesquita Filho” Faculdade de Medicina de Botucatu-FMB/UNESP
Eligibility
Age
7 Years to 18 Years
Inclusion criteria
Inclusion criteria: Patients between the ages of 7 and 18 years of age, of both sexes, with a diagnosis of CIC, established according to the criteria of Rome IV, and classified as having intractable intestinal constipation, according to the definition of the European Societies ( ESPGHAN) and North American (NASPGHAN) Gastropediatrics, represented by patients unresponsive to standard treatment, after a period of threE months
Exclusion criteria
Exclusion criteria: Patients whose parents and / or guardians do not agree to participate in the study and who do not sign the Free and Informed Consent Term, as well as patients between the ages of 12 and 18 who do not sign their consent form, will be excluded. Patients with any identifiable organic cause for intestinal constipation will be excluded from the study. Exclusion criteria will also be considered: neurological and / or cognitive deficits, skin lesions in the region of application of electrodes, changes in local sensitivity, presence of cardiac pacemaker, children presenting with cardiac arrhythmias or cardiac arrhythmias, patients presenting incomplete questionnaires or that are subject to drug changes and the standard during the intervention period or who abandon the proposed electrostimulation treatment during the intervention period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in the evacuation pattern and in the quality of life of the children submitted to the intervention. The following instruments will be used to evaluate and quantify this expected improvement: Asked about the evaluation of the current clinical state; Modified Bristol scale for children (mBSFS-C) for stool consistency analysis; Intestine Function Index (BF-S); Fecal continence index; PEDs 4.0 questionnaire for quality of life assessment; the last 7 days.;The possibility of applying the electrostimulation therapy in a home environment, identified through a directed questionnaire to evaluate the applicability of the sessions. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Public ContactRebeca Rego
Universidade Estadual Paulista “Júlio de Mesquita Filho” Faculdade de Medicina de Botucatu-FMB/UNESP
Outcome results
None listed