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IRCT20230424057984N1 IRCT 2023-05-08 Shiraz University of Medical Sciences A comparative study of the effect of Kegel exercises and conventional therapy vs in treating functional constipation in children A comparative study of the effect of Kegel exercises and conventional therapy vs in treating functional constipation in children 2022-03-21 anticipated 64 Complete https://irct.ir/trial/69734 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The samples were allocated to two groups by random block method with 8 blocks of size 8. The information was placed inside envelopes, which were sealed and labeled with random numbers provided by the Allocation Random Software. Blocking and allocation sequence of envelopes for concealment was done by a person not involved in the research. 3 functional constipation. Intervention 1: Control group: Control group: The basic treatment including diet training, defecation training and polyethylene glycol syrup was used. In this way, 0.7 g/kg of polyethylene glycol syrup was given daily. Beside that, toilet training and diet were also done by a pediatrician. Intervention 2: Intervention group: Intervention group: in addition to 0.7gr / kg daily PEG syrup and toilet training and proper diet training, Kegel exercises were also taught to the child by a pediatric specialist in the presence of their parents, verbally as well as written form. Yes - There is a plan to make this available What will be shared: "Standard" by van Engelenburg et al. was conducted from December 2009 to May 2014 as a multicenter randomized trial on 53 children (age 5-16 years) with functional constipation based on Rome III criteria in Dutch hospitals. When: Three to four months To whom: Three to four months after the results are published Conditions: For all people Where to obtain: ansary.narges@yahoo.com Number 09133176480 How to obtain: After 3 months of treatment, the success rate of the treatment was compared between the two groups before and after the study. Comments: It is suggested that studies in this direction be carried out in multicenter in patients with functional constipation with different severities.
public Mohammad Hadi Imaniyeh
Namazi Hospital
Shiraz Iran (Islamic Republic of) 7193711351 +98 917 111 0674 imaniehm@sums.ac.ir Shiraz University of Medical Sciences scientific Narges Ansari
Namazi Hospital
Shiraz Iran (Islamic Republic of) 7193711351 +98 913 317 6480 ansary.narges@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) • Age 8 to 18 years Willingness to participate Parent(s) sign the informed consent Functional constipation according to Rome Iv 8 years 18 years Both Severe delay in motor skills development Constipation caused by medicine Bowel surgery (except appendectomy) Endocrine and metabolic disorders (hypothyroidism, hypercalcemia, diabetes mellitus, diabetes insipidus) Neurological and psychiatric disorders (spina bifida, cerebral palsy, anorexia nervosa, autism, or PDD-NOS) Down syndrome Hirschsprung's disease K59.0 Constipation Treatment - Other Treatment - Other Control group: Control group: The basic treatment including diet training, defecation training and polyethylene glycol syrup was used. In this way, 0.7 g/kg of polyethylene glycol syrup was given daily. Beside that, toilet training and diet were also done by a pediatrician Intervention group: Intervention group: in addition to 0.7gr / kg daily PEG syrup and toilet training and proper diet training, Kegel exercises were also taught to the child by a pediatric specialist in the presence of their parents, verbally as well as written form. Frequency of defecation. Timepoint: At the beginning of the study (before the start of the intervention) then 3 months later. Method of measurement: Likert scale: 2 times a week, once a week, less than once a week, less than once a month. Duration of defecation. Timepoint: At the beginning of the study (before the start of the intervention) then 3 months later. Method of measurement: Likert scale: less than 5 minutes, 5-10 minutes, 10-20 minutes. Incomplete evacuation of stool. Timepoint: At the beginning of the study (before the start of the intervention) then 3 months later. Method of measurement: Likert scale: never, rarely, sometimes, usually. Abdominal pain. Timepoint: At the beginning of the study (before the start of the intervention) then 3 months later. Method of measurement: Likert scale: never, rarely, sometimes, usually. Shiraz University of Medical Sciences Approved 2022-12-06 Ethics Committee of Shiraz University of Medical Sciences Namazi Hospital Shiraz Fars Iran (Islamic Republic of)