Protocol summary
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Study aim
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Comparison of the effect of pelvic physiotherapy with standard medical care on functional constipation in children
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Design
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Clinical trial, interventional, parallel groups, single blind, quality, Quadratic block randomization
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Settings and conduct
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Outpatient patients referred to gastroenterology clinic of Shahid Beheshti hospital of Kashan University of Medical Sciences are first visited and examined by pediatric gastroenterologist. Questionnaires are prepared and then randomly enrolled into two groups. The group is treated with polyethylene glycol as standard drug treatment and the second group is given pelvic physiotherapy.
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Participants/Inclusion and exclusion criteria
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1. Children 6 to 15 years
2. Children with chronic functional constipation
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Intervention groups
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Pelvic physiotherapy group and standard medical care group (recipient of polyethylene glycol powder)
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Main outcome variables
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Pediatric Constipation Score
General information
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Reason for update
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Due to the postponement of the recruitment, the recruitment dates was also corrected.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191111045403N1
Registration date:
2020-02-01, 1398/11/12
Registration timing:
prospective
Last update:
2020-02-15, 1398/11/26
Update count:
1
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Registration date
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2020-02-01, 1398/11/12
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-02-09, 1398/11/20
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Expected recruitment end date
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2020-04-08, 1399/01/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effectiveness of pelvic physiotherapy in children With functional constipation compared with standard medical care
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Public title
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Effectiveness of pelvic physiotherapy in constipation
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
children With functional constipation
children in 5 -15 old years
Exclusion criteria:
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
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Age
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From 6 years old to 15 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
68
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Samples will be selected by simple non-probability sampling method and then allocaetd into two groups by four-block randomization method.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-10-06, 1398/07/14
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Ethics committee reference number
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IR.KAUMS.REC.1398.040
Health conditions studied
1
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Description of health condition studied
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Functional constipation in children
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ICD-10 code
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K59.09
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ICD-10 code description
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constipation
Primary outcomes
1
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Description
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Pediatric Constipation Score
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Timepoint
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At the beginning of the study(before intervention) and at 2 and 6 months after intervention
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Method of measurement
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Pediatrics Incontinence/Constipation Score Questionnaire(PICS)
Secondary outcomes
1
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Description
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Quality of life score
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Timepoint
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At the beginning of the study(before intervention) and at 2 and 6 months after intervention
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Method of measurement
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Based on the Quality of Life Questionnaire in Constipation Patients (PAC-QOL)
2
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Description
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Abdominal pain score
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Timepoint
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At the beginning of the study (before intervention) and at 2 and 6 months after intervention
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Method of measurement
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Abdominal pain based on the Visual Analog Scale and Wong-baker FACES
3
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Description
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Prebaseline pelvic floor muscles activity
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Timepoint
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At the beginning of the study (before the intervention) and after the intervention
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Method of measurement
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Surface Electromyography Based on millivolt
4
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Description
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Postbaseline pelvic floor muscles activity
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Timepoint
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At the beginning of the study (before the intervention) and after the intervention
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Method of measurement
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Surface Electromyography Based on millivolt
5
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Description
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Endurance of pelvic floor muscles
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Timepoint
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At the beginning of the study (before the intervention) and after the intervention
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Method of measurement
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Surface Electromyography Based on millivolt
6
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Description
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Strength of pelvic floor muscles
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Timepoint
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At the beginning of the study (before the intervention) and after the intervention
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Method of measurement
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Surface Electromyography Based on millivolt
7
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Description
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Pediatric Fecal Incontinence Scale
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Timepoint
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At the beginning of the study(before intervention) and at 2 and 6 months after intervention
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Method of measurement
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Pediatrics Incontinence/Constipation Score Questionnaire(PICS)
Intervention groups
1
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Description
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Intervention group: Pelvic Physiotherapy Receiving Group
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Category
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Treatment - Other
2
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Description
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Intervention group: Group receiving drug therapy
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available