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Comparison of effect of tele health– nursing and multimedia education of mothers on the growth and developmental indexes of infants, Compared with mothers who received training of health care workers

Protocol summary

Summary
Objective: Comparison of effect of tele health– nursing and multimedia education of mothers on the growth and developmental indexes of infants (6-12 months). The study population: Infants 6-12 months and their mothers. Sampling procedure: Random stratified sampling method was used. At first 3 health care centers were selected by random cluster sampling and then they allocated into 3 groups including: tele health- nursing, multimedia education and control by simple random sampling (43 subject in each group). Blindness is not carried out due to educational interventions. Inclusion criteria: Mother is willing to cooperate in this project, literate and with capability of mental, hearing and visual for participating in study and having a phone. Exclusion criteria: At the time of the study children go to kindergarten and become ill or chronic disease. Intervention: at the first intervention necessary educations were presented by phone calls. They were also given a phone number for further and necessary consults. The second intervention group was educated by lecture, film and pamphlet. Control group no received specific intervention. Intervention time: Developmental indexes at 6,8,10 and 12 months and growth indexes at 6, 7, 9 and 12 months measured. Primary outcomes: weight, length, head circumference, communication, gross motor, fine motor, problem solving and personal-social.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016030225127N2
Registration date: 2016-03-25, 1395/01/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-03-25, 1395/01/06
Registrant information
Name
Elham Farahnak
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 917 714 1935
Email address
farahnake@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Yasuj University of Medical Sciences
Expected recruitment start date
2015-06-20, 1394/03/30
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of tele health– nursing and multimedia education of mothers on the growth and developmental indexes of infants, Compared with mothers who received training of health care workers
Public title
The Effect of education on The indexes of growth and development of 6-12 months infants
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: mother is willing to cooperate in this project; mother has direct responsible for child's feeding; the father and mother be literate (at least secondary education is completed); the mother does not express certain mental problem; no graduates or studying in sciences or psychology or medicine; children at the time of the study not have defects, acute illness or not systematic; children have normal growth at baseline (is not Under 3 percentile ); parents are both still alive; having a home phone or mobile phone. Exclusion criteria: at the time of the study children go to kindergarten; children become ill or chronic disease; the child get single parent; the child's father become unemployed; the child's mother begin studying the medical sciences or psychology; parents cancel to continue working with more than two absences researcher training sessions or care.
Age
From 6 months old to 12 months old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 129
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Blindness is not carried out due to educational interventions

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj Univercity of Medical Science, Shahid Motahari street
City
Yasuj
Postal code
Approval date
2015-05-22, 1394/03/01
Ethics committee reference number
IR.YUMS.REC.1394.2

Health conditions studied

1

Description of health condition studied
Infants growth & developement
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Weight
Timepoint
At the end of 6, 7, 9 and 12 months
Method of measurement
By Scale

2

Description
Length
Timepoint
At the end of 6, 7, 9 and 12 months
Method of measurement
Length measured with meters

3

Description
Head circumference
Timepoint
At the end of 6, 7, 9 and 12 months
Method of measurement
Head circumference measured with meters

4

Description
Development
Timepoint
At the end of 6, 8, 10 and 12 months
Method of measurement
By using Ages and Stages Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In the first intervention group (long distance-tele- health nursing education method), procedures of surveying, education, orientation and suggestion were performed and used. For 6-8 months age children, phone connections were performed once a week regarding to Nutrition Education Protocol suggested by the Health Ministry of Iran according to items mentioned in children development profiles, assigned at 6, 7, 9 and 12 months of children age. Necessary educations were presented as weekly phone calls and the questions of parents were answered and were consulted if required. Contents of the next week were educated in each phone call and previous efforts were also checked and emphasized if were not obeyed. Two phone calls were performed for children with age of 9 months and more per week and the mother were referred to reserved physician if medical intervention was required. They were also given a phone number for further and necessary consults.
Category
Behavior

2

Description
In the second intervention group (multi media education method), the education process was based on lectures in group sessions according to an educational program. These educational sessions were formed at 6,8,10 and 12 moths of children ages regarding to the time of َAges and Stages questionnaire filling. Because of the dissipation of children ages and large number of people in a group, children born at the first half of month were educated at the beginning of the corresponding month and children born at the second half of month were educated at the last days of month by multimedia method. Also an educational film containing items about supplementary nutrition, use of iron supplementary droplets, emotional relations performance with the suckle, quality and modality of games at different ages and protection of the baby against accidents was shown to the mothers. Duration of each session was an hour. Educational pamphlets containing the issues of next 2 months according to the phone educations were given to the participants at the end of each session and they were asked to read the contents of each next week at corresponding week time. All educational contents and concepts were similar in both intervention groups. These educations were presented besides and apart of educations and recommendations offered by health personnel of mentioned health and medical centers.
Category
Behavior

3

Description
In the control group, only educations through the health care personnel were presented. ages and stages questionnaires were filled at the end of 6, 8, 10 and 12 months during interviews by the mothers
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Ashrafi Martyr, Health Center
Full name of responsible person
Elham Farahnak, Master of Nursing
Street address
Ave. Imam Khomein, Sharafabad town
City
Yasuj

2

Recruitment center
Name of recruitment center
Shafiei Martyr, Health Center
Full name of responsible person
Elham Farahnak, Master of Nursing
Street address
Yas street, Shahid salari boulevard
City
Yasuj

3

Recruitment center
Name of recruitment center
Dastgheib Martyr Health Center
Full name of responsible person
Elham Farahnak, Master of Nursing
Street address
Next to blood transfusion center, Jahad Blvd.
City
Yasuj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Yasouj University of Medical Sciences .
Full name of responsible person
Mohammad Mousavi
Street address
Yasouj Univercity of Medical Science, Motahari Bolvar, Yasouj
City
yassouj
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, Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Elham Farahnak
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Univercity of Medical Science, Dr.Jalil street, Yasouj
City
yasouj
Postal code
Phone
+98 74 3223 5138
Fax
Email
farahnake@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Nazafarin Hosseini
Position
PhD in Nursing
Other areas of specialty/work
Street address
Univercity of Medical Science, Dr.Jalil street, Yasouj
City
Yasouj
Postal code
Phone
+98 74 2332 3411
Fax
Email
hosseinichenar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Elham Farahnak
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Univercity of Medical Science, Dr.Jalil street, Yassouj
City
Yasuj
Postal code
Phone
+98 74 3223 5138
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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