Comparison of the efficacy of pharmacological and non-pharmacological therapy via group education on the control of primary nocturnal enuresis in school age children
Study objective: To determine effectiveness of non-pharmacological and pharmacological treatment via group education on the control of primary nocturnal enuresis in school age children. This study is a randomized clinical trial. Inclusion criteria:at least 2 periods of enuresis per week for 3 consecutive months; Enuresis is not affected by mental and physical illness; Patients and families have not previously participated in the training groups. Exclusion criteria: Parents have no willingness to continue cooperation. not participate in at least one training session. The study population consisted of school children aged 6 to 12 years old with nocturnal enuresis and the sample size is 64. Study interventions included: non-pharmacological treatment intervention (group education), by the researcher on a group of 32 people and pharmacological treatment intervention, by a physician on a group of 32 people. Intervention period is three months. Before, during and after the intervention, the mean number of wet nights and the rate of improvement is evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014102719702N1
Registration date:2014-12-06, 1393/09/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-12-06, 1393/09/15
Registrant information
Name
Sima Soroush
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61133738310
Email address
soroush.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences,Chronic Disease Care Research Center
Expected recruitment start date
2014-12-07, 1393/09/16
Expected recruitment end date
2015-02-05, 1393/11/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of pharmacological and non-pharmacological therapy via group education on the control of primary nocturnal enuresis in school age children
Public title
children enuresis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: at least 2 periods of enuresis per week for 3 consecutive months; Enuresis is not affected by mental and physical illness; Patients and families have not previously participated in the training groups. Exclusion criteria: Parents have no willingness to continue cooperation; not participate in at least one training session.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Vice Chancellor for Research and Technology Ahvaz Jundishapur University of Medical Sciences
Street address
Vice Chancellor for Research and Technology Ahvaz Jundishapur University of Medical Sciences,Ahvaz Jundishapur University of Medical Sciences, University City, Golestan Alley, Ahvaz
City
ahvaz
Postal code
61357-15794
Approval date
2014-09-20, 1393/06/29
Ethics committee reference number
ajums.REC.1393.201
Health conditions studied
1
Description of health condition studied
nocturnal enuresis
ICD-10 code
F98.0
ICD-10 code description
Nonorganic enuresis
Primary outcomes
1
Description
control of nocturnal enuresis
Timepoint
Before intervention, First month, second month, third month, After intervention
Method of measurement
Observation
Secondary outcomes
empty
Intervention groups
1
Description
Non-pharmacological therapy: parental education will be done, two educational group discussions sessions (sessions two weeks apart) will be held, in which parents will be divided into groups of 5-6 people. after completion of education check list for recording recommended daily activities for three months and educational booklet will be given to the parents
Category
Behavior
2
Description
Drug therapy group: Desmopressin tablets (120 microgr), once daily for 3 months is prescribed by a physician.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital special clinic
Full name of responsible person
Sima Soroush
Street address
Golestan Hospital Special Clinic, Golestan Hospital, Golestan Avenue, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ashraf alsadat Hakim
Street address
Ahvaz Jundishapur University of Medical Sciences, University City, Golestan Alley, Ahvaz
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sima Soroush
Position
Master of Pediatric Nursing Student
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, University city, Golestan Alley, Ahvaz
City
Ahvaz
Postal code
Phone
+98 613738269
Fax
Email
soroush.s@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Ashraf Alsadat Hakim
Position
Educator
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, University City, Golestan Alley, Ahvaz
City
Ahvaz
Postal code
Phone
+98 613738269
Fax
Email
hakim3448200@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sima Soroush
Position
Master of Pediatric Nursing student
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, University city, Golestan Alley, Ahvaz
City
Ahvaz
Postal code
Phone
00
Fax
Email
soroush.s@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)