Hypno-breastfeeding EducationNCT05500313
The Effect of Education and Counseling Based on HypnoBreastfeeding
A study testing Hypno-breastfeeding Education and Experimental: Standart Breastfeeding Education in people with Hypno-breastfeeding Education, run by Mersin University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypno-breastfeeding Education
- What is being tested?
- Hypno-breastfeeding Education and Experimental: Standart Breastfeeding Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jul 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Complications,
- Psychological or psychiatric disorder,
- Un-available follow-upps
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education and Counseling Based on HypnoBreastfeeding Philosophy on Breastfeeding Status, Breastfeeding Self-Efficacy and Breastfeeding Motivation
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.
Read the detailed description
This is a non-randomized experimental study. Data were collected from 80 women who attended hypno-breastfeeding-based education or standart breastfeeding education from Turkey between September 2021 and February 2022. Participants who met the inclusion criteria were informed about the purpose of the study and hypno-breastfeeding-based education or standart breastfeeding education, informed consent was obtained from those who agreed to participate. Data were collected at the time of consent to the study, pre-education, post-education, 1 week and 8 weeks after birth. Collected by the first author. The CONSORT directive was followed in the planning, implementation and writing of the research.
- Conditions
- Hypno-breastfeeding Education
- Being tested
- Hypno-breastfeeding Education, Experimental: Standart Breastfeeding Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypno-breastfeeding EducationBehavioural
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 EducationBehavioural
The standard breastfeeding education program consists of 1 session and 3 hours. It contains only information and applications about breastfeeding.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Experimental: Standart Breastfeeding Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Postpartum 8 st week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start27 Jul 2021
- Primary completion15 Sep 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypno-breastfeeding EducationStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gozde Gokce Isbir, Mersin University
- Investigators
- Gozde Gokce Isbir, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500313
- Sponsor's protocol ID
- NS
- Status last verified
- Mar 2023
- First submitted
- 11 Aug 2022
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education and Counseling Based on HypnoBreastfeeding Philosophy on Breastfeeding Status, Breastfeeding Self-Efficacy and Breastfeeding Motivation
- ClinicalTrials.gov ID
- NCT05500313
- Acronym / sponsor ID
- NS
- Conditions
- Hypno-breastfeeding Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a non-randomized experimental study. Data were collected from 80 women who attended hypno-breastfeeding-based education or standart breastfeeding education from Turkey between September 2021 and February 2022. Participants who met the inclusion criteria were informed about the purpose of the study and hypno-breastfeeding-based education or standart breastfeeding education, informed consent was obtained from those who agreed to participate. Data were collected at the time of consent to the study, pre-education, post-education, 1 week and 8 weeks after birth. Collected by the first author. The CONSORT directive was followed in the planning, implementation and writing of the research.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypno-breastfeeding Education | Experimental | Behavioral: Hypno-breastfeeding EducationAn 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. |
| Standart Breastfeeding Education | Experimental | Behavioral: Experimental: Standart Breastfeeding EducationAn 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Complications,
- Psychological or psychiatric disorder,
- Un-available follow-upps
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypno-breastfeeding EducationThe 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. | Behavioural | Hypno-breastfeeding Education |
| Experimental: Standart Breastfeeding EducationThe standard breastfeeding education program consists of 1 session and 3 hours. It contains only information and applications about breastfeeding. | Behavioural | Standart Breastfeeding Education |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Individual participant dataSharing planned: No
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The Effect of Hypno-Lactation Counseling on Breastfeeding Self-Efficacy and Breastfeeding Success in Adolescent Pregnant Women
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gozde Gokce Isbir principal investigator
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypno-breastfeeding Education and Experimental: Standart Breastfeeding Education in people with Hypno-breastfeeding Education, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of breastfeeding self-efficacy (time frame: Between 28-34 weeks of pregnancy). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.