NCT05500313

Brief Summary

The aim of this study is to determine the effect of education and counseling based on the hypno-breastfeeding philosophy given in the antenatal period on only breastfeeding status, breastfeeding self-efficacy and breastfeeding motivation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

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

July 27, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

August 11, 2022

Last Update Submit

March 13, 2023

Conditions

Outcome Measures

Primary Outcomes (8)

  • Level of breastfeeding self-efficacy

    Women's breastfeeding self-efficacy during pregnancy were evaluated with the Breastfeeding Self-efficacy Scale. This scale was developed by Dennis et al (2003) for fear after childbirth. The Turkish validity and reliability of the scale were performed by Tokat et al. (2010). This scale consisting of 14 items is a 5-point Likert-type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 14 to 70. The scale has no cutoff score, and high scores indicated higher breastfeedin self- efficacy. There are two versions of the scale used during pregnancy and postpartum. In both versions, the items are the same and the tenses change. In order to evaluate the Turkish validity and reliability of both antenatal and postnatal versions of the scale, language, structure and predictive validity analyzes were performed and the Cronbach's alpha value was found to be 0.87 for the antenatal measurement tool and 0.86 for the postnatal measurement tool.

    Between 28-34 weeks of pregnancy

  • Level of breastfeeding self-efficacy

    Women's breastfeeding self-efficacy during pregnancy were evaluated with the Breastfeeding Self-efficacy Scale. This scale was developed by Dennis et al (2003) for fear after childbirth. The Turkish validity and reliability of the scale were performed by Tokat et al. (2010). This scale consisting of 14 items is a 5-point Likert-type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 14 to 70. The scale has no cutoff score, and high scores indicated higher breastfeedin self- efficacy. There are two versions of the scale used during pregnancy and postpartum. In both versions, the items are the same and the tenses change. In order to evaluate the Turkish validity and reliability of both antenatal and postnatal versions of the scale, language, structure and predictive validity analyzes were performed and the Cronbach's alpha value was found to be 0.87 for the antenatal measurement tool and 0.86 for the postnatal measurement tool.

    Between 30-36 weeks of pregnancy

  • Level of breastfeeding self-efficacy

    Women's breastfeeding self-efficacy at the postpartum period were evaluated with the Breastfeeding Self-efficacy Scale. This scale was developed by Dennis et al (2003) for fear after childbirth. The Turkish validity and reliability of the scale were performed by Tokat et al. (2010). This scale consisting of 14 items is a 5-point Likert-type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 14 to 70. The scale has no cutoff score, and high scores indicated higher breastfeedin self- efficacy. There are two versions of the scale used during pregnancy and postpartum. In both versions, the items are the same and the tenses change. In order to evaluate the Turkish validity and reliability of both antenatal and postnatal versions of the scale, language, structure and predictive validity analyzes were performed and the Cronbach's alpha value was found to be 0.87 for the antenatal measurement tool and 0.86 for the postnatal measurement tool.

    Postpartum 1st week

  • Level of breastfeeding motivation

    In order to improve the breastfeeding motivation of women in the postpartum period, Peleg et al. Breastfeeding Motivation Scale was developed by in 2015. The scale consists of 24 items and 5 sub-dimensions. The scale does not have a total score. The scores of the sub-dimensions are calculated by taking the average of the sub-dimension scores of the scale. As the score obtained from the scale sub-dimension increases, the motivation score representing that sub-dimension also increases. The Turkish adaptation of the scale was carried out by Mızrak and Özdoğan in 2017, and the cronbach alpha value was determined as 0.88.

    Postpartum 1st week

  • Breastfeeding Process Evaluation Form

    The breastfeeding process evaluation form was created by the researchers as a result of the literature review in order to determine the status of exclusive breastfeeding in the first eight weeks and the factors affecting it. Breastfeeding processes evaluation form consists of 20 questions.

    Postpartum 1st week

  • Level of breastfeeding self-efficacy

    Women's breastfeeding self-efficacy at the postpartum period were evaluated with the Breastfeeding Self-efficacy Scale. This scale was developed by Dennis et al (2003) for fear after childbirth. The Turkish validity and reliability of the scale were performed by Tokat et al. (2010). This scale consisting of 14 items is a 5-point Likert-type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 14 to 70. The scale has no cutoff score, and high scores indicated higher breastfeedin self- efficacy. There are two versions of the scale used during pregnancy and postpartum. In both versions, the items are the same and the tenses change. In order to evaluate the Turkish validity and reliability of both antenatal and postnatal versions of the scale, language, structure and predictive validity analyzes were performed and the Cronbach's alpha value was found to be 0.87 for the antenatal measurement tool and 0.86 for the postnatal measurement tool.

    Postpartum 8 st week

  • Level of breastfeeding motivation

    In order to improve the breastfeeding motivation of women in the postpartum period, Peleg et al. Breastfeeding Motivation Scale was developed by in 2015. The scale consists of 24 items and 5 sub-dimensions. The scale does not have a total score. The scores of the sub-dimensions are calculated by taking the average of the sub-dimension scores of the scale. As the score obtained from the scale sub-dimension increases, the motivation score representing that sub-dimension also increases. The Turkish adaptation of the scale was carried out by Mızrak and Özdoğan in 2017, and the cronbach alpha value was determined as 0.88.

    Postpartum 8 st week

  • Breastfeeding Process Evaluation Form

    The breastfeeding process evaluation form was created by the researchers as a result of the literature review in order to determine the status of exclusive breastfeeding in the first eight weeks and the factors affecting it. Breastfeeding processes evaluation form consists of 20 questions.

    Postpartum 8 st week

Study Arms (2)

Hypno-breastfeeding Education

EXPERIMENTAL

An announcement was made on social media platforms for hypno-breastfeeding education programme, and they were invited to the education. Pre-applicant women were informed about the education and research process and their informed consent was signed via e-mail. An average of 4-5 women were included in each group. this group, the training consisted of 4 sessions and a total of 12 hours. It included information about breastfeeding, hypnosis approaches and different techniques. In line with the demands of the group, the session days and hours were decided with together. The Hypno-Breastfeeding Education Programme was offered to each group in a maximum of 2 weeks.

Behavioral: Hypno-breastfeeding Education

Standart Breastfeeding Education

EXPERIMENTAL

An announcement was made on social media platforms for standart breatfeeding education programme, and they were invited to the education. Pre-applicant women were informed about the education and research process and their informed consent was signed via e-mail.This education was done in one go. In this group, the training consisted of 1 sessions and a total of 3 hours. It included only information about breastfeeding.

Behavioral: Experimental: Standart Breastfeeding Education

Interventions

The hypnobreastfeeding education program consists of 4 sessions and 12 hours. It includes information about breastfeeding, mental preparation for the breastfeeding experience, emotional studies, motivational practices, awareness and self-compassion practices.

Hypno-breastfeeding Education

The standard breastfeeding education program consists of 1 session and 3 hours. It contains only information and applications about breastfeeding.

Standart Breastfeeding Education

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Must be able to a healthy pregnancy,
  • Native language is Turkish,
  • Have single fetus
  • Must be able to breastfeeding with her baby
  • Must be able to join wit education.

You may not qualify if:

  • Complications,
  • Psychological or psychiatric disorder,
  • Un-available follow-upps

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gozde Gokce Isbir

Mersin, 33180, Turkey (Türkiye)

Location

Study Officials

  • Gozde Gokce Isbir

    Mersin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 15, 2022

Study Start

July 27, 2021

Primary Completion

September 15, 2021

Study Completion

December 31, 2022

Last Updated

March 15, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations