ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Education on Breast Feeding on Primiparous Women

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.
ClinicalTrials.gov Identifier: NCT01645878
Recruitment Status : Terminated
First Posted : July 20, 2012
Last Update Posted : July 20, 2012
Sponsor:
Information provided by (Responsible Party):
Sedigeh Azhari, Mashhad University of Medical Sciences

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Breastfeeding Behavioral: hands on Behavioral: hands off Behavioral: routin breast feeding education Phase 2 Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : January 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: July 20, 2012    Key Record Dates
Last Update Posted: July 20, 2012
Last Verified: January 2010

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