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Effect of Education on Breast Feeding on Primiparous Women

This study has been terminated.
ClinicalTrials.gov Identifier:
First Posted: July 20, 2012
Last Update Posted: July 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sedigeh Azhari, Mashhad University of Medical Sciences

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: None (Open Label)
Primary Purpose: Supportive Care

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Breast feeding self-efficacy [ Time Frame: up to 2 month ]

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
Routin breast feeding education
Behavioral: routin breast feeding education


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
No Contacts or Locations Provided
  More Information

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
First Submitted: July 17, 2012
First Posted: July 20, 2012
Last Update Posted: July 20, 2012
Last Verified: January 2010

Keywords provided by Sedigeh Azhari, Mashhad University of Medical Sciences:
Primiparous Mothers
hands off,
hands on ,
social cognitive theory