Comparison of the effect of multimedia film and booklet on mother self-efficacy and healthy newborn care behavior in primipara mothers: A randomized controlled trial
Objectives: This study aims to compare the effects of multimedia film and educational booklet on self-efficacy and care behavior of healthy newborn in primipara mothers.
Design: A single-blind Randomized Controlled Trial.
Setting and conduct: This study will be conducted in health centers of Miandoab city. Eligible women will be selected with convenience sampling and will be randomly assigned into 3 groups of 126 subjects with block sizes of 3 and 6. A person from research team not involved in the recruitment and assigning participants will generate allocation sequence using a computerized program. Opaque sealed sequentially numbered envelops will be used for allocation concealment.
Participants: 126 primipara pregnant women with gestational age of 36 to 38 weeks.
Interventions: The first intervention groups will receive the educational CD and the second intervention group will receive educational booklet. Educational CD has been developed by the Ministry of Health. The booklet also will set by researcher with the same educational content. The control group also will receive postpartum routine care.
Main outcome measures include Maternal self efficacy and newborn care behavior and secondary outcomes include knowledge of newborn care and maternal self-confidence that will be evaluated before and 4 weeks after childbirth.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071410324N23
Registration date:2015-08-06, 1394/05/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-06, 1394/05/15
Registrant information
Name
Mojgan Mirghafourvand
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6969
Email address
mirghafourvandm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-08-01, 1394/05/10
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of multimedia film and booklet on mother self-efficacy and healthy newborn care behavior in primipara mothers: A randomized controlled trial
Public title
Comparison of the effect of multimedia film and booklet on mother self-efficacy and healthy newborn care behavior in primipara mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Desire to participate in the study; Having at least secondary school education; Being nulliparous and having singleton pregnancy, Term healthy child; Having the ability to see and hear; Having a computer or a DVD.
Exclusion criteria: Existence of mental –psychological diseases according to mother expression; High-risk pregnancy according to prenatal care records; Hospitalized newborns in NICU or malformed newborn.
Age
To 50 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
126
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 Tabriz University of Medical Sciences
Street address
Research department, third floor, central construction number 2, Tabriz University of Medical Sciences, Golgasht Street, Azadi Avenue, Tabriz, East Azerbaijan
City
Tabriz
Postal code
Approval date
2015-07-06, 1394/04/15
Ethics committee reference number
TBZMED.REC.1394.344
Health conditions studied
1
Description of health condition studied
Newborn care
ICD-10 code
Z76.2
ICD-10 code description
Health supervision and care of other healthy infant and child
Primary outcomes
1
Description
Maternal self efficacy
Timepoint
Baseline and 4 weeks after childbirth
Method of measurement
Maternal self efficacy questionnaire
2
Description
Infant care behavior
Timepoint
Baseline and 4 weeks after childbirth
Method of measurement
A researcher made questionnaire
Secondary outcomes
1
Description
Knowledge of newborn care
Timepoint
Baseline and 4 weeks after childbirth
Method of measurement
A researcher made questionnaire
2
Description
Maternal self-confidence
Timepoint
Baseline and 4 weeks after childbirth
Method of measurement
Self-confidence questionnaire
Intervention groups
1
Description
The first intervention group will receive education by multimedia film. Educational film has been developed by the Ministry of Health that will be provided to participants at 36-38 weeks of pregnancy.
Category
Behavior
2
Description
The control group will receive postpartum routine care.
Category
N/A
3
Description
The second intervention group will receive education by educational booklet. Educational booklet has been developed by the researcher with same contents of educational film that will be provided to participants at 36-38 weeks of pregnancy.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health centers of Miandoab City
Full name of responsible person
Somayeh Jamalivand
Street address
City
Miandoab
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Rashidi Mohammad Reza
Street address
Research department, third floor, central construction number 2, Tabriz medical science university, Golgasht Street, Azadi Avenue, Tabriz
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences, Nursing & Midwifery Faculty
Full name of responsible person
Somayeh Jamalivand
Position
MSc student in Midwifery
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
3417174914
Phone
+98 41 3331 2679
Fax
Email
Jamalivandsomayeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science, Nursing & Midwifery Faculty
Full name of responsible person
Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
34751745
Phone
+98 41 1479 6770
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Science, Nursing & Midwifery Faculty
Full name of responsible person
Mojgan Mirghafourvand
Position
PhD of Reproductive Health
Other areas of specialty/work
Street address
Nursing & Midwifery Faculty, South Shariati Street
City
Tabriz
Postal code
34751745
Phone
+98 41 3479 6770
Fax
Email
Mirghafourvandm@tbzmed.ac.ir; mirg1385@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)