Impact of the nurse led approaches on functional chronic constipation in 3 to 14 year old children referred to Imam Reza clinic, Shiraz University of Medical Sciences
Objective: Determining the impact of nurse led approaches on functional chronic constipation in 3 to14 year old children referred to Imam Reza clinic. inclusion criteria :Having aged 3 to 14 years old;Having constipation during the 2 months prior to entrance to the study;Children with the diagnosis of functional chronic constipation based on Rome 3 criteria and physician`s approval. Exclusion criteria:Children diagnosed with IBS;Children with mental retardation or metabolic disorders (such as hypothyroidism);children with drugs affecting gastrointestinal motility or any kind of traditional medicine or other conventional medical treatment . Method: Randomized clinical trial with intervention and control group. Study population:3 to14 year old patients having functional chronic constipation referred to Imam Reza clinic in Shiraz. Sample: 95 patients (47 patients in experimental group and 48 patients in control group). Intervention and time of the study:nurse led approaches which is based on two main components: training and following up. Training sessions were presented to patients and their parents in three ninety minute sessions in lecture,question and answer, and educational pamphlets.follow up was done during three months after intervention. primary consequence is the percentage of improvement in functional chronic constipation and secondary consequences of this study are 6 items of Rome 3 criteria
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014062918270N1
Registration date:2014-07-22, 1393/04/31
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-07-22, 1393/04/31
Registrant information
Name
Zohre Faramarzian
Name of organization / entity
Shiraz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 1230 5410
Email address
faramarziz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-Chancellor for Research and Technology of Shiraz University of Medical Sciences
Expected recruitment start date
2013-11-18, 1392/08/27
Expected recruitment end date
2014-03-22, 1393/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of the nurse led approaches on functional chronic constipation in 3 to 14 year old children referred to Imam Reza clinic, Shiraz University of Medical Sciences
Public title
The impact of nurse led approaches on functional chronic constipation of children
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: Having aged 3 to 14 years old; Having constipation during the 2 months prior to entrance to the study;Children with diagnosis of functional chronic constipation based on Rome 3 criteria and physician`s approval; Having informed consent and willingness to participate in the study;Parents are literate enough to read and write Farsi; The participation of parents and children in all training and counseling sessions.
Exclusion criteria: Children diagnosed with IBS;Children with mental retardation or metabolic disorders (such as hypothyroidism);Children with diagnosis of spinal anomalies or Hirschsprung's disease or anorectalpathology;Children who have undergone gastrointestinal surgery; children who receive drugs affecting gastrointestinal motility or any kind of traditional medicine or other conventional medical treatment; Lack of desire to continue the study
Age
From 3 years old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
95
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Seventh floor, Shiraz University of Medical Sciences and Health Services, Next to Red Crescent Organization, Zand blvd
City
Shiraz
Postal code
1978-71345
Approval date
2013-11-18, 1392/08/27
Ethics committee reference number
6775-92 -CT
Health conditions studied
1
Description of health condition studied
constipation
ICD-10 code
k59.0
ICD-10 code description
constipation
Primary outcomes
1
Description
improvement of constipation
Timepoint
1month,2months and 3 months after intervention
Method of measurement
bowel dairy
Secondary outcomes
1
Description
two or fewer defecation in the toilet per week
Timepoint
Before starting the study,1month,2months and 3 months after intervention
Method of measurement
bowel dairy
2
Description
at least one episode of fecal incontinence per week
Timepoint
before starting the study,1month,2 months and 3 months after intervention
Method of measurement
bowel dairy
3
Description
history of retentive posturing or excessive volitional stool retention
Timepoint
Before starting the study,1month,2months and 3 months after intervention
Method of measurement
bowel dairy
4
Description
history of painful or hard bowel movement
Timepoint
Before starting the study,1month,2months and 3 months after intervention
Method of measurement
bowel dairy
5
Description
presence of a large fecal mass in the rectum
Timepoint
Before starting the study,1month,2months and 3 months after intervention
Method of measurement
bowel dairy
6
Description
history of large diameter stools that may obstruct the toilet
Timepoint
Before starting the study,1month,2months and 3 months after intervention
Method of measurement
bowel dairy
Intervention groups
1
Description
Intervention group: routine treatment plus nurse led approaches which consists of 2 main components education and follow up. Training sessions were presented to patients and their parents in three ninety minute sessions in lecture, question and answer, and educational pamphlets.follow up was done during three months after intervention .
Category
Behavior
2
Description
control group:routin treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Clinic related to Shiraz University of Medical Science
Full name of responsible person
Dr Safi اari
Street address
Namazi square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research and Technology of Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholamreza Hatam
Street address
Seventh floor, Shiraz University of Medical Sciences and Health Services, Next to Red Crescent Organization, Zand blvd
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research and Technology of Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzie Kargar
Position
MS in Nursing
Other areas of specialty/work
Street address
Shiraz University of Medical Scinces and Health Services, Next to Red Crescent Organization, Zand blvd
City
Shiraz
Postal code
71345-1978
Phone
+98 71 1647 4258
Fax
Email
kargarm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Seied Mohsen Dehghani
Position
Pediatric Gastroenterologist
Other areas of specialty/work
Street address
Shiraz University of Medical Scinces and Health Services, Next to Red Crescent Organization, Zand blvd
City
Shiraz
Postal code
71345-1978
Phone
+98 71 1230 5410
Fax
Email
dehghanism@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Marzie Kargar
Position
MS in Nursing
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences and Health Services, Next to Red Crescent Organization, Zand blvd
City
Shiraz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)