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General information
2020-01-30, 1398/11/10
2020-02-09, 1398/11/20
2020-0102-3009 00:00:00
2020-03-29, 1399/01/10
2020-04-08, 1399/01/20
2020-0304-2908 00:00:00
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Due to the postponement of the recruitment, the recruitment dates was also corrected.
Due to the postponement of the recruitment, the recruitment dates was also corrected.
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با توجه به تعویق افتادن بیمارگیری، تاریخ بیمارگیری نیز اصلاح شد.
با توجه به تعویق افتادن بیمارگیری، تاریخ بیمارگیری نیز اصلاح شد.
Recruitment centers
#1
Name of recruitment center - English: Specialty Gastroenterology Clinic Shahid Beheshti Hospital Kashan University of Medical Sciences
Name of recruitment center - Persian: درمانگاه فوق تخصصی گوارش بیمارستان شهید بهشتی دانشگاه علوم پزشکی کاشان کاشان
Full name of responsible person - English: Abbas Taghavi Ardakani ; Seyed Ramin Madani
Full name of responsible person - Persian: عباس تقوی اردکانی ، سید رامین مدنی اردکانی
Street address - English: Faculty of Medicine - Kashan University of Medical Sciences -pezeshk Blvd - 3km of Ravand Road
Street address - Persian: کیلومتر 3 جاده راوند- بلوار پزشک - دانشکده پزشکی دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 88715973474
Phone: +98 31 5562 1550
Fax:
Email: medicine@kaums.ac.ir
Web page address:
Name of recruitment center - English: Specialty Gastroenterology Clinic Shahid Beheshti Hospital Kashan University of Medical Sciences
Name of recruitment center - Persian: درمانگاه فوق تخصصی گوارش بیمارستان شهید بهشتی دانشگاه علوم پزشکی کاشان کاشان
Full name of responsible person - English: Abbas Taghavi Ardakani; Seyed Ramin Madani
Full name of responsible person - Persian: عباس تقوی اردکانی؛ سید رامین مدنی اردکانی
Street address - English: Faculty of Medicine, Kashan University of Medical Sciences, pezeshk Blvd., 3km of Ravand Road
Street address - Persian: کیلومتر 3 جاده راوند، بلوار پزشک، دانشکده پزشکی دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 88715973474
Phone: +98 31 5562 1550
Fax:
Email: medicine@kaums.ac.ir
Web page address:
Name of recruitment center - English: Specialty Gastroenterology Clinic Shahid Beheshti Hospital Kashan University of Medical Sciences Name of recruitment center - Persian: درمانگاه فوق تخصصی گوارش بیمارستان شهید بهشتی دانشگاه علوم پزشکی کاشان کاشان Full name of responsible person - English: Abbas Taghavi Ardakani; Seyed Ramin Madani Full name of responsible person - Persian: عباس تقوی اردکانی ،؛ سید رامین مدنی اردکانی Street address - English: Faculty of Medicine -, Kashan University of Medical Sciences -, pezeshk Blvd -., 3km of Ravand Road Street address - Persian: کیلومتر 3 جاده راوند-، بلوار پزشک -، دانشکده پزشکی دانشگاه علوم پزشکی کاشان City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 88715973474 Phone: +98 31 5562 1550 Fax: Email: medicine@kaums.ac.ir Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hamid Reza Banafsheh
Full name of responsible person - Persian: حمیدرضا بنفشه
Street address - English: Faculty of Medicine - Kashan University of Medical Sciences -pezeshk Blvd - 3km of Ravand Road
Street address - Persian: کاشان - کیلومتر 3 جاده راوند- بلوار پزشک - دانشکده پزشکی دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 88715973474
Phone: +98 31 5510 9999
Fax:
Email: medicine@kaums.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Hamid Reza Banafsheh
Full name of responsible person - Persian: حمیدرضا بنفشه
Street address - English: Faculty of Medicine, Kashan University of Medical Sciences, pezeshk Blvd., 3km of Ravand Road
Street address - Persian: کیلومتر 3 جاده راوند، بلوار پزشک، دانشکده پزشکی دانشگاه علوم پزشکی کاشان
City - English: Kashan
City - Persian: کاشان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 88715973474
Phone: +98 31 5510 9999
Fax:
Email: medicine@kaums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Hamid Reza Banafsheh Full name of responsible person - Persian: حمیدرضا بنفشه Street address - English: Faculty of Medicine -, Kashan University of Medical Sciences -, pezeshk Blvd -., 3km of Ravand Road Street address - Persian: کاشان - کیلومتر 3 جاده راوند-، بلوار پزشک -، دانشکده پزشکی دانشگاه علوم پزشکی کاشان City - English: Kashan City - Persian: کاشان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 88715973474 Phone: +98 31 5510 9999 Fax: Email: medicine@kaums.ac.ir Web page address:
Protocol summary
Study aim
Comparison of the effect of pelvic physiotherapy with standard medical care on functional constipation in children
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.
Participants/Inclusion and exclusion criteria
1. Children 6 to 15 years
2. Children with chronic functional constipation
Intervention groups
Pelvic physiotherapy group and standard medical care group (recipient of polyethylene glycol powder)
Main outcome variables
Pediatric Constipation Score
General information
Reason for update
Due to the postponement of the recruitment, the recruitment dates was also corrected.
Acronym
IRCT registration information
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
Registration date
2020-02-01, 1398/11/12
Registrant information
Name
Amin ali Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
rahimi-a@mail.kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-09, 1398/11/20
Expected recruitment end date
2020-04-08, 1399/01/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of pelvic physiotherapy in children With functional constipation compared with standard medical care
Public title
Effectiveness of pelvic physiotherapy in constipation
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 6 years old to 15 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be selected by simple non-probability sampling method and then allocaetd into two groups by four-block randomization method.
Blinding (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Faculty of Medicine, Kashan University of Medical Sciences, pezeshk Blvd., 3km of Ravand Road
City
Kashan
Province
Isfehan
Postal code
88715973474
Approval date
2019-10-06, 1398/07/14
Ethics committee reference number
IR.KAUMS.REC.1398.040
Health conditions studied
1
Description of health condition studied
Functional constipation in children
ICD-10 code
K59.09
ICD-10 code description
constipation
Primary outcomes
1
Description
Pediatric Constipation Score
Timepoint
At the beginning of the study(before intervention) and at 2 and 6 months after intervention