Investigating the effect of Kegel exercises on the treatment of children's constipation
Design
This clinical trial was conducted on 8to 18-year-old children with functional constipation, according to Rome IV, who referred to the pediatric section of Imam Reza Clinic in Shiraz, Iran, in 2022. The sample consisted of 64 children who were randomly assigned to either the intervention or the control group. In the control group, conventional therapy including diet training, defecation training, and polyethylene glycol (PEG) syrup (0.7 g/kg daily) was provided by a pediatrician (5). In the treatment group, in addition to conventional therapy, Kegel exercises were also taught to the child verbally and in writing by a pediatrician in the presence of their parents. Patients were examined 3 months after the intervention. Frequency of defecation, duration of Defecation, painful defecation, Assistance used for defecation, Incomplete emptying, Unsuccessful defecation and Abdominal pain were measured at the final week of the intervention compared to baseline.
Settings and conduct
patients who referred to the pediatric section of Imam Reza Clinic from September to December 2022, those with a history of more than six consecutive months of constipation were screened.
Participants/Inclusion and exclusion criteria
Age 8 to 18 years
• Functional constipation according to Rome IV criteria
• Willingness to participate
Intervention groups
Kegel exercise compared to children using only standard drug treatment.
Main outcome variables
Determining the amount of change in the number of bowel movements ؛ change in time spent on the toilet;change in the effort to empty painful stools ؛change in the feeling of incomplete emptying ؛unsuccessful attempts to defecate over 24 hours ؛abdominal pain in constipated children who perform Kegel exercises compared to children who only use standard medical treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230424057984N1
Registration date:2023-05-08, 1402/02/18
Registration timing:retrospective
Last update:2023-05-08, 1402/02/18
Update count:0
Registration date
2023-05-08, 1402/02/18
Registrant information
Name
Narges Ansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 6524
Email address
ansary.narges@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
2022-03-21, 1401/01/01
Actual recruitment end date
2022-09-21, 1401/06/30
Trial completion date
empty
Scientific title
A comparative study of the effect of Kegel exercises and conventional therapy vs in treating functional constipation in children
Public title
A comparative study of the effect of Kegel exercises and conventional therapy vs in treating functional constipation in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Age 8 to 18 years
Willingness to participate
Parent(s) sign the informed consent
Functional constipation according to Rome Iv
Exclusion criteria:
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
Age
From 8 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Actual sample size reached:
64
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Namazi Hospital
City
Shiraz
Province
Fars
Postal code
۱۳۳۱۱ – ۷۱۹۳۶
Approval date
2022-12-06, 1401/09/15
Ethics committee reference number
IR.SUMS.MED.REC.1401.438
Health conditions studied
1
Description of health condition studied
functional constipation
ICD-10 code
K59.0
ICD-10 code description
Constipation
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Other
2
Description
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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric section of Imam Reza Clinic
Full name of responsible person
Narges Ansari
Street address
Namazi Hospital
City
Shiraz
Province
Fars
Postal code
۱۳۳۱۱ – ۷۱۹۳۶
Phone
+98 913 317 6480
Email
Ansary.narges@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempur
Street address
Namazi Hospital
City
Shiraz
Province
Fars
Postal code
۱۳۳۱۱ – ۷۱۹۳۶
Phone
+98 913 317 6480
Email
hashempur@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hadi Imaniyeh
Position
Professor
Latest degree
Medical doctor
Other areas of specialty/work
Pediatric gastroenterologist
Street address
Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 917 111 0674
Email
imaniehm@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Narges Ansari
Position
Fellowship
Latest degree
Medical doctor
Other areas of specialty/work
Pediatric gastroenterologist
Street address
Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 913 317 6480
Email
ansary.narges@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
The university of shiraz
Full name of responsible person
Narges Ansari
Position
Fellowship
Latest degree
Ph.D.
Other areas of specialty/work
Pediatric Gastroenterologist
Street address
Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7193711351
Phone
+98 71 3628 6524
Fax
Email
ansary.narges@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
"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 the data will become available and for how long
Three to four months
To whom data/document is available
Three to four months after the results are published
Under which criteria data/document could be used
For all people
From where data/document is obtainable
ansary.narges@yahoo.com
Number 09133176480
What processes are involved for a request to access data/document
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.