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Effect of visceral manipulation on children with chronic functional constipation

Protocol summary

Study aim
Effect of visceral manipulation on children with chronic functional constipation
Design
Clinical trial with control group, with parallel groups, one blind, randomized
Settings and conduct
This study is a clinical trial conducted in physiotherapy clinics of the Jundishapur University of Medical Sciences in Ahvaz on children with functional constipation. Children aged 5 to 18, who according to the gastroenterologist, have chronic functional constipation, are assessed in terms of inclusion and exclusion criteria, which, if they are eligible, are included in the study, then the subjects were randomly assigned to control and intervention groups then the evaluator who is not aware of the type of patient group will measure the variables specified. In both control and intervention groups, standard medical treatments are given, but only in the intervention group patients are given 2 times per week for 4 weeks of treatment with visceral manipulation techniques. At the end of the week, the variables in the two groups are reassessed by the evaluator.
Participants/Inclusion and exclusion criteria
The conditions of entry include functional constipation, age 5-18 and duration of affection at least 3 months, and non-entry conditions including metabolic and endocrine disorders, Hirschsprung's disease, Down syndrome, neurological and neurological disorders, and congenital anorectal malformations.
Intervention groups
The groups included control and intervention groups. In both groups, standard medical treatments, including medication, nutritional and behavioral counseling are applied, but in the intervention group, the visceral manipulation techniques is also used.
Main outcome variables
Abdominal Pain; Defecation Pain; Fecal Consistency; Stool Frequency; Dose of Laxative

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190614043891N1
Registration date: 2019-12-04, 1398/09/13
Registration timing: prospective

Last update: 2019-12-04, 1398/09/13
Update count: 0
Registration date
2019-12-04, 1398/09/13
Registrant information
Name
Syed Arman Zkaryaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3743 1013
Email address
armanzakaryaei22@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of visceral manipulation on children with chronic functional constipation
Public title
Effect of viseral manipulation in constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All children with Functional constipation aged 5 to 18 years At least 3 months have passed since they occurred
Exclusion criteria:
Endocrine and Metabolic disorders (eg, Hypothyroidism, Hypercalcemia, Diabetes mellitus) Neurologic and Psychiatric disorders(Spina bifida, Cerebral palsy, Autism) Hirschsprung’sdisease and Down’s syndrome Congenital anorectal malformation
Age
From 5 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization will be used to assimilate the number of samples in control and treatment groups. This randomization is performed among patients with functional constipation referred to Abu Dhar Hospital. The blocks consist of 6 blocks of 4 that 5 blocks will select between the 6 possible modes of the blocks . In these blocks, the letter A is assigned to the control group and the letter B to the treatment group.Depending on the order of the letters A and B at the time of referral, the patient falls into the control or treatment group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the person evaluating outcomes is unaware of the type of grouping and treatments applied to each group. Also, the data analyzer is not aware of the relationship between the data and the type of group and merely compiles statistical analyzes on data collection.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Faculty of Rehabilitation Sciences
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2019-07-15, 1398/04/24
Ethics committee reference number
IR.AJUMS.REC.1398.293

Health conditions studied

1

Description of health condition studied
Constipation
ICD-10 code
K59.9
ICD-10 code description
Functional intestinal disorder, unspecified

Primary outcomes

1

Description
Bristol scale score that measure the consistency and shape of the stool
Timepoint
At the beginning of the study (before the intervention) and 28 days after the intervention
Method of measurement
Bristol Stool Form Scale

2

Description
Score of defecation pain
Timepoint
At the beginning of the study (before the intervention) and 28 days after the intervention
Method of measurement
Wong-Baker Faces Pain Rating Scale

3

Description
Score of abdominal pain
Timepoint
At the beginning of the study (before the intervention) and 28 days after the intervention
Method of measurement
Wong-Baker Faces Pain Rating Scale

4

Description
Number of defecation per week
Timepoint
At the beginning of the study (before the intervention) and 28 days after the intervention
Method of measurement
Patient report

Secondary outcomes

1

Description
Dosage of laxative drug
Timepoint
At the beginning of the study (before the intervention) and 28 days after the intervention
Method of measurement
Patient report

Intervention groups

1

Description
Intervention group: In the intervention group, in addition to the standard medical treatments that are given in both groups, visceral manipulation techniques are applied for four weeks and two weeks each week for these patients.
Category
Rehabilitation

2

Description
Control group: Interventions in this group are standard medical treatments. These treatments include the use of medicines prescribed by the pediatric gastroenterologist, parents and children's education about the symptoms of the disease, nutritional counseling (the effect of fluid and fiber intake), and behavioral training.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Majid Ravanbakhsh
Street address
Ahvaz Jundishapur University of Medical Sciences, Faculty of Rehabilitation Sciences
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3743 1013
Fax
+98 61 3374 3506
Email
Ahvaz-rehab@ajums.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3336 2414
Fax
+98 61 3336 1544
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Ravanbakhsh
Position
Associate professo
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
33133 -61357
Phone
+98 61 3743 1013
Fax
+98 61 3374 3506
Email
majidravanbakhsh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Majid Ravanbakhsh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
33133 -61357
Phone
+98 61 3743 1013
Fax
+98 61 3374 3506
Email
majidravanbakhsh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Syed Arman Zkaryaei
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
15794 -61357
Phone
+98 61 3743 1013
Fax
+98 61 3374 3506
Email
armanzakaryaei22@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The whole potential data is published after being unidentifiable
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
If someone wants to do the same research project
From where data/document is obtainable
Executor of plan: Dr.Majid ravanbakhsh E-mail: majidravanbakhsh@yahoo.com
What processes are involved for a request to access data/document
By sending an E-mail with a full explanation of the reason for requesting the documentation and the purpose of having it
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