Overall Objectives: Comparing the effect of distance education and multimedia education on the success of breastfeeding in preterm infants after discharge
Type of research: randomized clinical trial
Criteria for entering the study: A baby with a gestational age of 37-35 weeks who has a discharge order and the majority of his breastfeeding nutrition. The mother has literacy and reading skills and resides in Mashhad. Exit criteria during the study: The baby is dead.
Sample size: 30 neonates in each intervention group. A total of 60 neonates.
Primary intervention: In the first intervention group, the delivery of a multimedia educational CD will be delivered and a two-time phone call will be made and non-interactive to ensure that the CD is viewed every other week. For the second group of intervention, by telegram, up to three weeks after the discharge of the baby, three times a week will be taught in the evening (5-7 pm), and the educational videos in the multimedia will be placed in the telegram for the mothers and the mothers Any questions will be raised in the group and their answers will be given.
Main measurable consequences: success in breastfeeding by the IBFAT and BEET tools
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2016081929418N1
Registration date:2017-08-02, 1396/05/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-02, 1396/05/11
Registrant information
Name
Mahvan Khodaparast
Name of organization / entity
North Khorasan Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 58 3222 5886
Email address
khodaparastm931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Mashhad University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare Telenursing and multimedia on breastfeeding success in preterm infants after discharge
Public title
Telenursing and multimedia effects on breastfeeding success in preterm infants after discharge
Purpose
Supportive
Inclusion/Exclusion criteria
Neonatal Entry Criteria for Study:
1. Conscious consent of the parents to participate in the intervention.
2. The fetal age is 35-37 weeks.
3. The baby has an order for discharge.
4. There is no congenital anomalies.
5- Most of the baby's feeding during discharge is breast milk.
6. There is no heart disease.
7. There is no confirmed metabolic disease.
Exit criteria during the study:
1. Infant die.
2- Mother's desire to leave the study.
Mothers Entry Criterion:
1- Ability to speak Persian language.
2- Resident of Mashhad city
3- Have read and write literacy.
4. Have a smartphone (with a telegram) (in the Telenursing group).
5. The mother does not have a medical prohibition for breastfeeding (HTLV1)
Age
From 1 day old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Use the blocking method
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences and Health Services.
Street address
Ibn Sina-street intersection.
City
Mashhad
Postal code
9137913199
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
IR.MUMS.REC.1395.74
Health conditions studied
1
Description of health condition studied
Breast-feeding premature infants
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Successful Breastfeeding
Timepoint
28 days after the intervention
Method of measurement
BEET and IBFAT Tools
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group 2: Training through the telegram, and its final examination by the standard lactation success tool, including IBFAT and BEET, which is a table tool that is completed three weeks after the discharge.
Category
Other
2
Description
Intervention group 1: Multimedia education provided by the Ministry of Health and its final review by the standard lactation success tool, including IBFAT and BEET, which is a table tool that is completed three weeks after discharge.
Intervention group 2: Training through the telegram, and its final examination by the standard lactation success tool, including IBFAT and BEET, which is a table tool that is completed three weeks after the discharge.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital.
Full name of responsible person
Ms. Parvini
Street address
Taqi Abad Square
City
mashhad
2
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Ms.Mir
Street address
Ibn Sina Street
City
Mashhad
3
Recruitment center
Name of recruitment center
Ommol Banin Hospital
Full name of responsible person
MS.Asef
Street address
Ayatollah Bahjat Bahjat street corner 16
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Mashhad University of Medical Sciences
Full name of responsible person
Islami Saeed
Street address
Daneshgah Avenue
City
Mashhad
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 of Mashhad 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
Mashhad University of Medical Sciences and Health Services.
Full name of responsible person
Tayebbeh Reyhani
Position
Master of nursing
Other areas of specialty/work
Street address
Ibn Sina Street - School of Nursing Jorjani
City
Mashhad
Postal code
Phone
+98 51 3859 1513
Fax
Email
ReyhaniT@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences and Health Services
Full name of responsible person
Tayebeh Reyhani
Position
Master of nursing
Other areas of specialty/work
Street address
Ibn Sina Street - School of Nursing Jorjani
City
Mashhad
Postal code
13944-91388
Phone
+98 51 3859 1513
Fax
+98 51338413006
Email
presidentoffice[at]mums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)