Protocol summary

Summary
The aim of this randomized controlled clinical trial is to evaluate the effect of self efficacy-based training package on maternal self-confidence and Sense of competency of primiparous women for infant care. Inclusion criteria were primiparous women without postpartum depression and a normal infant and exclusion criteria were do not reading instructional book and Not possible to turn both telephone counseling. This study was conducted on 60 primiparous first mothers (30 control,30 intervention) referred to health care centers of Mashhad. self efficacy-based training package consisting of a face to face training sessions, instructional booklet contains common questions and answers, instructional videos and two sessions of telephone counseling was prepared and implemented for intervention group. The control group just received routine care. The intervention began 10-15 days after birth outcomes of the study included the maternal self efficacy, self-confidence and sense of competence, that were completed before and eight weeks after intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014012416335N1
Registration date: 2014-03-16, 1392/12/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-03-16, 1392/12/25
Registrant information
Name
Elham Azmoude
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
azmoudehe901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of self-efficacy-based training package on maternal self-confidence and Sense of competency of primiparous for infant caring
Public title
Effect of training on maternal's self-confidence and Sense of competency
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: being primiparous; residing in Mashhad; feasibility of calling; singleton pregnancy and normal gestational week; absence of medical diseases; Health baby without abnormalities; living with spouse; absence of history of infertility and mental illness or psychiatric drugs using; not suffering from postpartum depression; absence of substance abuse. Excusion Criteria: a degree in Medical Sciences; stressful event during the study; not wanting to continue survey; infants hospitalization during the study or his separation from the mother for any reason; infant death; not possible to connect both calls; reading less than half of the pages of booklet; not seeing educational film.
Age
To 1 year old
Gender
Female
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
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
mashhad, St. daneshgah
City
Mashhad
Postal code
920229
Approval date
2013-08-19, 1392/05/28
Ethics committee reference number
920229

Health conditions studied

1

Description of health condition studied
Optimal Care for Infants
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
before intervention + Two months after the start of the intervention
Method of measurement
Reece expectation survey

2

Description
Maternal self confidence
Timepoint
Before intervention, Two months after the start of the intervention
Method of measurement
Lips maternal self confidence

3

Description
Maternal sense of competency
Timepoint
Before intervention, Two months after the start of the intervention
Method of measurement
Parenting sense of competency

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group are trained by using self efficacy promotions Strategies, including of: a face to face training sessions on the first day of intervention, instructional booklet contains common questions and answers and 30 minute instructional videos, that the subjects were given the same day and two sessions of telephone counseling , that were conducted one and three weeks after the start of intervention.
Category
Behavior

2

Description
The control group were received routine postpartum training.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Care Centers of Mashhad
Full name of responsible person
Farzane Jafarnejad
Street address
Mashhad School of Nursing and Midwifery
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Mashhad University of Medical Sciences
Full name of responsible person
Dr.Tafaghodi
Street address
Building Qureshi, Daneshgah Ave, Mashhad, Iran
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council 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
Full name of responsible person
Elham Azmoude
Position
MSc in Midwifery
Other areas of specialty/work
Street address
Mashhad School of Nursing and Midwifery, Four-way Phd, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
azmoudehe901@mums.ac.ir e.jordvay@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Nursing and Midwifery, Mashhad
Full name of responsible person
Farzaneh Jafarnejad
Position
MSc in Midwifery,Faculty member of School of Nursing and Midwifery, Mashhad
Other areas of specialty/work
Street address
Mashhad School of Nursing and Midwifery, Four-way Phd, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
jaafarnejadf@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Elham Azmoude
Position
MSC in Midwifery
Other areas of specialty/work
Street address
Mashhad School of Nursing and Midwifery, Four-way Phd, Mashhad, Iran
City
Mashhad
Postal code
Phone
+98 51 1859 1511
Fax
Email
Azmoudehe901@mums.ac.ire.jordvay@yahoo.com
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
empty
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