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IRCT20191111045403N1 IRCT 2020-02-01 Kashan University of Medical Sciences Effectiveness of pelvic physiotherapy in constipation Effectiveness of pelvic physiotherapy in children With functional constipation compared with standard medical care 2020-02-09 anticipated 68 Complete https://irct.ir/trial/43943 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Samples will be selected by simple non-probability sampling method and then allocaetd into two groups by four-block randomization method, Blinding description: Allocations were randomly assigned to two groups using computer software previously specified by the statistical specialist and patients would be assigned to either group A or group B, outcome assessor and data analyzer Which group of patients received drug treatment or physiotherapy is not known. This study is a unilateral blinded researcher. 3 Functional constipation in children. Intervention 1: Intervention group: Pelvic Physiotherapy Receiving Group. Intervention 2: Intervention group: Group receiving drug therapy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I don't yet have enough information on how to publish
public Amin Ali Rahimi
Faculty of Medicine, Kashan University of Medical Sciences, Medical Blvd., 3km of Ravand Road
Kashan Iran (Islamic Republic of) 88715973474 0098 31 55540021-25 Rahimi-a@mail.kaums.ac.ir Kashan University of Medical Sciences scientific Amin Ali Rahimi
Faculty of Medicine- Kashan University of Medical Sciences- pezeshk Blvd- 3km of Ravand Road
Kashan Iran (Islamic Republic of) 88715973474 0098 31 55540021-25 Rahimi-a@mail.kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) children With functional constipation children in 5 -15 old years 6 years 15 years Both Children with metabolic and endocrine diseases such as hypothyroidism, diabetes mellitus, diabetes mellitus and hypercalcemia, etc. Children with neurological or psychiatric illnesses such as spina bifida, cerebral palsy, anorexia nervosa, autism, neurofibromatosis, etc. Children with intestinal disease such as Hirschsprung's disease Children with Down Syndrome A history of intestinal surgery Children taking constipation drugs (anticholinergics, phenytoin, antidepressants, chemotherapy drugs such as vincristine, etc.) Children with fecal impaction Patients with a specific diet History of pelvic physiotherapy due to bladder or bowel problems during the past 3 months Perform any other remedies for constipation during the study Other Causes of Constipation, such as Scleroderma, Sexual Abuse, Cystic Fibrosis, and Dietary Protein Allergies K59.09 constipation Treatment - Other Treatment - Drugs Intervention group: Pelvic Physiotherapy Receiving Group Intervention group: Group receiving drug therapy Pediatric Constipation Score. Timepoint: At the beginning of the study(before intervention) and at 2 and 6 months after intervention. Method of measurement: Pediatrics Incontinence/Constipation Score Questionnaire(PICS). Quality of life score. Timepoint: At the beginning of the study(before intervention) and at 2 and 6 months after intervention. Method of measurement: Based on the Quality of Life Questionnaire in Constipation Patients (PAC-QOL). Abdominal pain score. Timepoint: At the beginning of the study (before intervention) and at 2 and 6 months after intervention. Method of measurement: Abdominal pain based on the Visual Analog Scale and Wong-baker FACES. Prebaseline pelvic floor muscles activity. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Surface Electromyography Based on millivolt. Postbaseline pelvic floor muscles activity. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Surface Electromyography Based on millivolt. Endurance of pelvic floor muscles. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Surface Electromyography Based on millivolt. Strength of pelvic floor muscles. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Surface Electromyography Based on millivolt. Pediatric Fecal Incontinence Scale. Timepoint: At the beginning of the study(before intervention) and at 2 and 6 months after intervention. Method of measurement: Pediatrics Incontinence/Constipation Score Questionnaire(PICS). Kashan University of Medical Sciences Approved 2019-10-06 Ethics committee of Kashan University of Medical Sciences Faculty of Medicine, Kashan University of Medical Sciences, pezeshk Blvd., 3km of Ravand Road Kashan Isfehan Iran (Islamic Republic of)