Effect of Education on Breast Feeding on Primiparous Women

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Sedigeh Azhari, Mashhad University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01645878

First received: July 17, 2012

Last updated: July 19, 2012

Last verified: January 2010

History of Changes

Purpose

Exclusive breastfeeding is very important for an infant's growth and development. Self-efficacy is a modifiable psychological variable in sustained breastfeeding that is defined as a mother's confidence in her perceived ability about successful exclusive breastfeeding. Self- efficacy beliefs function as an important set of human motivation , affect , and action which operate on action, through motivation, cognitive and affective interventing process. teaching strategies ,based on Bandura,s self-efficacy theory and adult learning principles were incorporated in this research design. In regards with the importance of education in increasing breastfeeding self-efficacy and exclusive breastfeeding, the current study was conducted in order to compare of the effectiveness of two educational methods, i.e., "Hands on" and" Hands off" on breastfeeding self-efficacy in primiparous mothers.

In the present clinical trial, 136 nursing mother were randomly assigned to one of the three groups. Participants in the experimental groups received one of the structured one-on-one educational sessions (i.e., hands off or hands on) within the first two hours of giving birth. Mothers in control group received usual postpartum care. Follow-up assessments were conducted one, four, and eight weeks after the birth. Data collection was done through interview forms, examination and observation, checklist of breastfeeding status, breastfeeding self-efficacy and daily-feeding form.

Condition	Intervention	Phase
Breastfeeding	Behavioral: hands on Behavioral: hands off Behavioral: routin breast feeding education	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care

Resource links provided by NLM:

MedlinePlus related topics: Breastfeeding

U.S. FDA Resources

Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:

Breast feeding self-efficacy [ Time Frame: up to 2 month ] [ Designated as safety issue: No ]


Enrollment:	136
Study Start Date:	January 2010
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Hands on breast feeding instructed by direct help of instructor	Behavioral: hands on in hands on group it was instructed by direct help of instructor, mothers could ask questions and if necessary it was done again by researcher.
Experimental: hands off	Behavioral: hands off In hands off group, was instructed by pictures, if mothers had questions, they could watch the pictures again
Control Routin breast feeding education	Behavioral: routin breast feeding education

Eligibility


Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

vaginal normal delivery normal neonate lack of maternal- neonatal lactation problems contact number satisfying in participation in study

Exclusion criteria would not like to continue used tranquilizers or experienced stressful events

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided


Responsible Party:	Sedigeh Azhari, Faculty member, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT01645878 History of Changes
Other Study ID Numbers:	Hands on and hands off
Study First Received:	July 17, 2012
Last Updated:	July 19, 2012
Health Authority:	Iran: Ethics Committee

Keywords provided by Mashhad University of Medical Sciences:


Primiparous Mothers self-efficacy, hands off, hands on , social cognitive theory

ClinicalTrials.gov processed this record on February 27, 2015

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