Pregnant WomenNCT06746662
The Effect of Hypno-Lactation Counseling on Breastfeeding Self-Efficacy and Breastfeeding Success in Adolescent Pregnant Women
A study testing Hypnobreastfeeding training and consultancy in people with Pregnant Women, run by Cukurova University.
Trial summary
This study aimed to investigate the effects of counseling based on hypno-breastfeeding philosophy on breastfeeding self-efficacy and breastfeeding success in pregnant adolescents. Read more about this study
- Who is it for?
- Ages 16 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Hypnobreastfeeding training and consultancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Between the ages of 16-19,
- Single pregnancy,
- Primiparous,
- Planning a normal vaginal birth,
- In the last trimester of pregnancy,
- No communication problems,
Show all 10Show fewer
- Can speak and understand Turkish,
- Can read and write, as the scales must be filled out by the individual,
- No condition preventing breastfeeding,
- Not receiving any training/counseling regarding breastfeeding during pregnancy
Who cannot join
- Women who have been diagnosed with a psychiatric disorder,
- Complications in the mother and baby (chronic disease in the mother that prevents breastfeeding; diabetes, hypertension, etc. fetal anomalies in the fetus, postpartum discomfort that will prevent breastfeeding),
- Women who develop a health problem during pregnancy during the training process,
- Women who want to withdraw from the study voluntarily
- Women who have any disability (hearing impairment, etc.) will be excluded from the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effect of Hypnobreastfeeding Philosophy-Based Counseling on Breastfeeding Self-Efficacy and Breastfeeding Success in Adolescent Pregnant Women
This study aimed to investigate the effects of counseling based on hypno-breastfeeding philosophy on breastfeeding self-efficacy and breastfeeding success in pregnant adolescents.
Research Hypotheses H1a: The intervention group\'s breastfeeding self-efficacy after hypno-breastfeeding counseling is different from the control group.
Read more
H1b: The intervention group\'s breastfeeding success after hypno-breastfeeding counseling is different from the control group.
This thesis is a randomized controlled experimental study. The study is planned to be conducted with two parallel groups, namely the intervention and control groups. Hypno-breastfeeding training will be applied to the intervention group, and standard breastfeeding training will be applied to the control group. The study will be conducted with pregnant adolescents who applied to the pregnancy clinic of Adıyaman University Training and Research Hospital between December 2024 and April 2025.
Read the detailed description
This study aimed to investigate the effects of counseling based on hypno-breastfeeding philosophy on breastfeeding self-efficacy and breastfeeding success in pregnant adolescents.
Place, type and time of the study This thesis study is a randomized controlled experimental study. The study is planned to be conducted with two parallel groups, the intervention and control groups. Hypno-breastfeeding training will be applied to the intervention group, and standard breastfeeding training will be applied to the control group. The study will be conducted with pregnant adolescents who applied to the pregnancy clinic of Adıyaman University Education and Research Hospital between December 2024 and April 2025.The Universe and Sample of the Study: The universe of the study consists of pregnant adolescents registered at the 400-bed Adıyaman University Training and Research Hospital.
Data Collection Tools Data will be collected using the Personal Information Form (Appendix 1), Breastfeeding Self-Efficacy Scale-Short Form (Appendix 2) and Breastfeeding Diagnostic Scale (LATCH) (Appendix 3) prepared by the researchers in line with the literature.
- Conditions
- Pregnant Women
- Being tested
- Hypnobreastfeeding training and consultancy
- Keywords
- Hypnobreastfeeding, breastfeeding self-efficacy, breast-feeding, Adolescent pregnant, breastfeeding success
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnobreastfeeding training and consultancyBehavioural
Hypno-breastfeeding Education Group
A counseling program based on hypno-breastfeeding philosophy, where 4-week education content will be presented to pregnant adolescents in their 28-30th week of pregnancy and applications will be made, will be implemented with 4 sessions and 6 follow-up
| Study group | Role | What they receive |
|---|---|---|
| Counseling based on the philosophy of hypnobreastfeeding | Experimental | Hypno-breastfeeding is a method that involves a natural effort to use subconscious energy so that the breastfeeding process can proceed comfortably and smoothly and the mother can produce enough breast milk for the baby's growth and development needs (AIMI, 2010; Sofiyanti et al., 2019). With hypno-breastfeeding, the breastfeeding process takes place comfortably and the mother subconsciously registers that breastfeeding is a natural and comfortable process (Sembırıng, 2017; Altıparmak, 2021; Kilçi Erciyas and Sevil, 2021). In the philosophy of hypno-breastfeeding, positive schemas for breastfeeding are created in the subconscious. By focusing on the use of the primitive brain, the stimulation of the neocortex with unnecessary information and stimuli is avoided (Aluş Tokat and Gökçe İsbir, 2023). This technique, which helps to facilitate a holistic look at the mind, body and soul of breastfeeding mothers, allows the mother to be more relaxed, calm and comfortable during breastfeeding Receives: Behavioral: Hypnobreastfeeding training and consultancy |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breastfeeding Self-Efficacy
The first form of the scale developed by Dennis and Faux was designed with 33 items, but after a second study, Dennis revised the scale and created a short form of 14 items (5). The Turkish validity and reliability study of the scale was conducted by Aluş Tokat and colleagues (6). The scale can be applied in the prenatal and postnatal periods and measures how adequate women feel about breastfeeding. The items of the five-point Likert-type scale are scored as not at all sure (1), not very sure (2), sometimes sure (3), sure (4), very sure (5). The lowest score that can be obtained from the entire evaluation scores of the scale is 14 and the highest score is 70. A low total score obtained from the scale indicates that the perception of breastfeeding self-efficacy is low.
Measured: Baseline, 4 week, and after the labour
Secondary outcomes (1)
Breastfeeding Success
The LATCH breastfeeding diagnosis and assessment scale is a diagnostic method used to assess breastfeeding success, first created in 1986 by resembling the APGAR scoring system in terms of scoring method . The average application time varies between 7-10 minutes. This measurement tool was developed to objectively diagnose breastfeeding, identify breastfeeding problems, create a common language among healthcare professionals and to be used in research (to determine breastfeeding success in longitudinal studies) . It consists of five evaluation criteria, and the abbreviation of the first letters of the English equivalents of these criteria constitutes the name of the scale.
Each item is evaluated between 0-2 points. The highest total score that can be obtained is 10, and a high score means a high breastfeeding success.
Measured: Baseline, 4 week, and after the labour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start15 Mar 2025 (estimated)
- Primary completion15 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Hypno-breastfeeding Education Group A counseling program based on hypno-breastfeeding philosophy, where 4-week education content will be presented to pregnant adolescents in their 28-30th week of pregnancy and applications will be made, will be implemented with 4 sessions and 6 follow-ups. A breastfeeding education booklet (Appendix 6) will be prepared in the implementation of the counseling service. Each session will last an average of 1 hour. The training sessions will be conducted face-to-face. The average number of pregnant women in each follow-up will consist of 3-5 people. During and after the training processes, pregnant women will be provided with regular information based on hypno-breastfeeding philosophy, affirmation, relaxation techniques and meditation materials (Appendix 6) and counseling based on hypno-breastfeeding philosophy. First follow-up (28-30th week of pregnancy - first encounter): This midwifery intervention will be performed on pregnant women in a suitable roo
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İpek TURAN, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746662
- Sponsor's protocol ID
- ipekt1
- Status last verified
- Feb 2025
- First submitted
- 3 Dec 2024
- Last updated
- 12 Feb 2025
- 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 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hypnobreastfeeding Philosophy-Based Counseling on Breastfeeding Self-Efficacy and Breastfeeding Success in Adolescent Pregnant Women
- ClinicalTrials.gov ID
- NCT06746662
- Acronym / sponsor ID
- ipekt1
- Conditions
- Pregnant Women
- Keywords
- Hypnobreastfeeding, breastfeeding self-efficacy, breast-feeding, Adolescent pregnant, breastfeeding success
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 24 Dec 2024 (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.
This study aimed to investigate the effects of counseling based on hypno-breastfeeding philosophy on breastfeeding self-efficacy and breastfeeding success in pregnant adolescents.
Research Hypotheses H1a: The intervention group\'s breastfeeding self-efficacy after hypno-breastfeeding counseling is different from the control group.
H1b: The intervention group\'s breastfeeding success after hypno-breastfeeding counseling is different from the control group.
This thesis is a randomized controlled experimental study. The study is planned to be conducted with two parallel groups, namely the intervention and control groups. Hypno-breastfeeding training will be applied to the intervention group, and standard breastfeeding training will be applied to the control group. The study will be conducted with pregnant adolescents who applied to the pregnancy clinic of Adıyaman University Training and Research Hospital between December 2024 and April 2025.
Detailed description
This study aimed to investigate the effects of counseling based on hypno-breastfeeding philosophy on breastfeeding self-efficacy and breastfeeding success in pregnant adolescents.
Place, type and time of the study This thesis study is a randomized controlled experimental study. The study is planned to be conducted with two parallel groups, the intervention and control groups. Hypno-breastfeeding training will be applied to the intervention group, and standard breastfeeding training will be applied to the control group. The study will be conducted with pregnant adolescents who applied to the pregnancy clinic of Adıyaman University Education and Research Hospital between December 2024 and April 2025.The Universe and Sample of the Study: The universe of the study consists of pregnant adolescents registered at the 400-bed Adıyaman University Training and Research Hospital.
Data Collection Tools Data will be collected using the Personal Information Form (Appendix 1), Breastfeeding Self-Efficacy Scale-Short Form (Appendix 2) and Breastfeeding Diagnostic Scale (LATCH) (Appendix 3) prepared by the researchers in line with the literature.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Hypno-breastfeeding Education Group A counseling program based on hypno-breastfeeding philosophy, where 4-week education content will be presented to pregnant adolescents in their 28-30th week of pregnancy and applications will be made, will be implemented with 4 sessions and 6 follow-ups. A breastfeeding education booklet (Appendix 6) will be prepared in the implementation of the counseling service. Each session will last an average of 1 hour. The training sessions will be conducted face-to-face. The average number of pregnant women in each follow-up will consist of 3-5 people. During and after the training processes, pregnant women will be provided with regular information based on hypno-breastfeeding philosophy, affirmation, relaxation techniques and meditation materials (Appendix 6) and counseling based on hypno-breastfeeding philosophy. First follow-up (28-30th week of pregnancy - first encounter): This midwifery intervention will be performed on pregnant women in a suitable roo
| Arm | Type | Receives |
|---|---|---|
| Counseling based on the philosophy of hypnobreastfeeding | Experimental | Behavioral: Hypnobreastfeeding training and consultancyHypno-breastfeeding is a method that involves a natural effort to use subconscious energy so that the breastfeeding process can proceed comfortably and smoothly and the mother can produce enough breast milk for the baby's growth and development needs (AIMI, 2010; Sofiyanti et al., 2019). With hypno-breastfeeding, the breastfeeding process takes place comfortably and the mother subconsciously registers that breastfeeding is a natural and comfortable process (Sembırıng, 2017; Altıparmak, 2021; Kilçi Erciyas and Sevil, 2021). In the philosophy of hypno-breastfeeding, positive schemas for breastfeeding are created in the subconscious. By focusing on the use of the primitive brain, the stimulation of the neocortex with unnecessary information and stimuli is avoided (Aluş Tokat and Gökçe İsbir, 2023). This technique, which helps to facilitate a holistic look at the mind, body and soul of breastfeeding mothers, allows the mother to be more relaxed, calm and comfortable during breastfeeding |
| Control | No intervention | – |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Between the ages of 16-19,
- Single pregnancy,
- Primiparous,
- Planning a normal vaginal birth,
- In the last trimester of pregnancy,
Key exclusion criteria (5 listed)
- Women who have been diagnosed with a psychiatric disorder,
- Complications in the mother and baby (chronic disease in the mother that prevents breastfeeding; diabetes, hypertension, etc. fetal anomalies in the fetus, postpartum discomfort that will prevent breastfeeding),
- Women who develop a health problem during pregnancy during the training process,
- Women who want to withdraw from the study voluntarily
- Women who have any disability (hearing impairment, etc.) will be excluded from the study.
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 |
|---|---|---|
| Hypnobreastfeeding training and consultancyHypno-breastfeeding Education Group A counseling program based on hypno-breastfeeding philosophy, where 4-week education content will be presented to pregnant adolescents in their 28-30th week of pregnancy and applications will be made, will be implemented with 4 sessions and 6 follow-up | Behavioural | Counseling based on the philosophy of hypnobreastfeeding |
Primary outcome
Breastfeeding Self-Efficacy
Time frame: Baseline, 4 week, and after the labour
The first form of the scale developed by Dennis and Faux was designed with 33 items, but after a second study, Dennis revised the scale and created a short form of 14 items (5). The Turkish validity and reliability study of the scale was conducted by Aluş Tokat and colleagues (6). The scale can be applied in the prenatal and postnatal periods and measures how adequate women feel about breastfeeding. The items of the five-point Likert-type scale are scored as not at all sure (1), not very sure (2), sometimes sure (3), sure (4), very sure (5). The lowest score that can be obtained from the entire evaluation scores of the scale is 14 and the highest score is 70. A low total score obtained from the scale indicates that the perception of breastfeeding self-efficacy is low.
1 secondary outcome
Breastfeeding Success
Time frame: Baseline, 4 week, and after the labour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnobreastfeeding training and consultancy in people with Pregnant Women, run by Cukurova University.
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 10 inclusion and 5 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: opening soon, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ipek T TURAN, Araştırma Görevlisi (90 - 05526310592, ipekturan02@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breastfeeding Self-Efficacy (time frame: Baseline, 4 week, and after the labour). 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 12 Feb 2025.