NCT01645878

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2010

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 20, 2012

Completed
Last Updated

July 20, 2012

Status Verified

January 1, 2010

Enrollment Period

1.7 years

First QC Date

July 17, 2012

Last Update Submit

July 19, 2012

Conditions

Keywords

Primiparous Mothersself-efficacy,hands off,hands on ,social cognitive theory

Outcome Measures

Primary Outcomes (1)

  • Breast feeding self-efficacy

    up to 2 month

Study Arms (3)

Hands on

EXPERIMENTAL

breast feeding instructed by direct help of instructor

Behavioral: hands on

hands off

EXPERIMENTAL
Behavioral: hands off

Control

OTHER

Routin breast feeding education

Behavioral: routin breast feeding education

Interventions

hands onBEHAVIORAL

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.

Hands on
hands offBEHAVIORAL

In hands off group, was instructed by pictures, if mothers had questions, they could watch the pictures again

hands off

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Feeding

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty member

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 20, 2012

Study Start

January 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

July 20, 2012

Record last verified: 2010-01