- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05500313
The Effect of Education and Counseling Based on HypnoBreastfeeding
The Effect of Education and Counseling Based on HypnoBreastfeeding Philosophy on Breastfeeding Status, Breastfeeding Self-Efficacy and Breastfeeding Motivation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Mersin, Turkey, 33180
- Gozde Gokce Isbir
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Complications,
- Psychological or psychiatric disorder,
- Un-available follow-upps
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hypno-breastfeeding Education
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.
|
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.
|
|
Experimental: Standart Breastfeeding Education
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.
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The standard breastfeeding education program consists of 1 session and 3 hours.
It contains only information and applications about breastfeeding.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Level of breastfeeding self-efficacy
Time Frame: Between 28-34 weeks of pregnancy
|
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
Time Frame: Between 30-36 weeks of pregnancy
|
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
Time Frame: Postpartum 1st week
|
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
Time Frame: Postpartum 1st week
|
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
|
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Breastfeeding Process Evaluation Form
Time Frame: Postpartum 1st week
|
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
Time Frame: Postpartum 8 st week
|
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
Time Frame: Postpartum 8 st week
|
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
Time Frame: Postpartum 8 st week
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- NS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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