High-risk PregnancyNCT07281339
Effect of Hypnobreastfeeding Education in High-Risk Pregnant Women
A study testing Hypnobreastfeeding Education in people with High-risk Pregnancy and Breast Feeding, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
It is thought that hypnobreastfeeding training given to high-risk pregnant women will reduce anxiety levels, increase lactation, encourage breastfeeding, reduce the perception of insufficient milk, and facilitate adaptation to the postpartum breastfeeding process. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- High-risk Pregnancy, Breast Feeding
- What is being tested?
- Hypnobreastfeeding Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2025to 30 Jun 2026
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- High-risk primiparous pregnant women
- Those with 28-34 weeks of pregnancy
- Those who volunteered to participate in the study
- Those who can read and write Turkish
Who cannot join
- Those with communication disabilities
- Those with psychiatric and mental illnesses
- Those who have an obstacle to breastfeeding
- Those who have previously attended a birth preparation class
- Those who receive breastfeeding-related training and consultancy
- Those who gave birth prematurely
- Those with anomalies in their babies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Amasya University
Amasya, 05000
Emine İBİCİ AKÇA, 0 358 211 50 05
About this study
Official title: The Effect of Hypnobreastfeeding Education Given to High-Risk Pregnant Women on Anxiety Levels, Infant Feeding Intention, Postpartum Perception of Insufficient Milk, and Breastfeeding Adaptation
It is thought that hypnobreastfeeding training given to high-risk pregnant women will reduce anxiety levels, increase lactation, encourage breastfeeding, reduce the perception of insufficient milk, and facilitate adaptation to the postpartum breastfeeding process. According to the results of the power analysis, at least 68 high-risk pregnant women, 34 experimental and 34 control, should be included in the study. Data will be collected with the "Pregnancy Information Form", "Anxiety Assessment Scale", " Infant Feeding Intention Instrument", "Postpartum Information Form", "Perception of Insufficient Milk Questionnaire" and "Breastfeeding Adaptation Scale". In the research, hypnobreastfeeding training will be applied by the researcher to the high-risk pregnant women in the experimental group.
Read the detailed description
Hypnobreastfeeding training provided to high-risk pregnant women is believed to reduce anxiety, increase lactation, encourage breastfeeding, reduce the perception of insufficient milk supply, and facilitate postpartum breastfeeding adaptation. This will ensure the baby receives adequate and healthy nutrition and the mother's self-confidence increases. Furthermore, hypnobreastfeeding training will contribute to a more comfortable, informed, and peaceful breastfeeding experience for the mother. This will positively impact both the pregnancy and the health of both mother and baby. The study was planned to evaluate the effects of hypnobreastfeeding training given to high-risk pregnant women on anxiety levels, breastfeeding intentions, postpartum perception of insufficient milk, and breastfeeding adaptation. According to the results of the power analysis, at least 68 high-risk pregnant women, 34 experimental and 34 control, should be included in the study. Data will be collected with the "Pregnancy Information Form", "Anxiety Assessment Scale", " Infant Feeding Intention Instrument", "Postpartum Information Form", "Perception of Insufficient Milk Questionnaire" and "Breastfeeding Adaptation Scale". In the research, hypnobreastfeeding training will be applied by the researcher to the high-risk pregnant women in the experimental group.
- Conditions
- High-risk Pregnancy, Breast Feeding
- Being tested
- Hypnobreastfeeding Education
- Keywords
- Hypnobreastfeeding, Anxiety, Infant Feeding Intention, Perception of Insufficient Milk, Breastfeeding Adaptation
- Medical subject headings
- Breast Feeding, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnobreastfeeding EducationBehavioural
Monitoring anxiety and breastfeeding intention in pregnancy, and assessing perception of insufficient milk supply, and breastfeeding adaptation in postpartum period
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Hypnobreastfeeding Education Receives: Behavioral: Hypnobreastfeeding Education |
| Control group | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Assessment Scale
The minimum score that can be obtained from the scale is "10", the maximum score is "50", and as the score obtained from the scale increases, anxiety levels also increase.
Measured: At the end of the 1 months
Infant Feeding Intention Instrument
The minimum score that can be obtained from the scale is "0", the maximum score is "16", and as the score obtained from the scale increases, intention to exclusively breastfeed the baby levels also increase.
Measured: At the end of the 1 months
Secondary outcomes (2)
Perception of Insufficient Milk Questionnaire
The minimum score that can be obtained from the scale is "0", the maximum score is "50", and as the score obtained from the scale increases, perception of milk sufficiency levels also increase.
Measured: Postpartum 24-48 hours, postpartum 2nd week and postpartum 4th week
Breastfeeding Adaptation Scale
The minimum score that can be obtained from the scale is "27", the maximum score is "135", and as the score obtained from the scale increases, breastfeeding adaptation levels also increase.
Measured: Postpartum 24-48 hours, postpartum 2nd week and postpartum 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start15 Oct 2025
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk PregnancyStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emine İbici Akça, PhD, Principal investigator, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281339
- Sponsor's protocol ID
- 2025000162
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hypnobreastfeeding Education Given to High-Risk Pregnant Women on Anxiety Levels, Infant Feeding Intention, Postpartum Perception of Insufficient Milk, and Breastfeeding Adaptation
- ClinicalTrials.gov ID
- NCT07281339
- Acronym / sponsor ID
- 2025000162
- Conditions
- High-risk Pregnancy, Breast Feeding
- Keywords
- Hypnobreastfeeding, Anxiety, Infant Feeding Intention, Perception of Insufficient Milk, Breastfeeding Adaptation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Dec 2025 (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.
It is thought that hypnobreastfeeding training given to high-risk pregnant women will reduce anxiety levels, increase lactation, encourage breastfeeding, reduce the perception of insufficient milk, and facilitate adaptation to the postpartum breastfeeding process. According to the results of the power analysis, at least 68 high-risk pregnant women, 34 experimental and 34 control, should be included in the study. Data will be collected with the "Pregnancy Information Form", "Anxiety Assessment Scale", " Infant Feeding Intention Instrument", "Postpartum Information Form", "Perception of Insufficient Milk Questionnaire" and "Breastfeeding Adaptation Scale". In the research, hypnobreastfeeding training will be applied by the researcher to the high-risk pregnant women in the experimental group.
Detailed description
Hypnobreastfeeding training provided to high-risk pregnant women is believed to reduce anxiety, increase lactation, encourage breastfeeding, reduce the perception of insufficient milk supply, and facilitate postpartum breastfeeding adaptation. This will ensure the baby receives adequate and healthy nutrition and the mother's self-confidence increases. Furthermore, hypnobreastfeeding training will contribute to a more comfortable, informed, and peaceful breastfeeding experience for the mother. This will positively impact both the pregnancy and the health of both mother and baby. The study was planned to evaluate the effects of hypnobreastfeeding training given to high-risk pregnant women on anxiety levels, breastfeeding intentions, postpartum perception of insufficient milk, and breastfeeding adaptation. According to the results of the power analysis, at least 68 high-risk pregnant women, 34 experimental and 34 control, should be included in the study. Data will be collected with the "Pregnancy Information Form", "Anxiety Assessment Scale", " Infant Feeding Intention Instrument", "Postpartum Information Form", "Perception of Insufficient Milk Questionnaire" and "Breastfeeding Adaptation Scale". In the research, hypnobreastfeeding training will be applied by the researcher to the high-risk pregnant women in the experimental group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Hypnobreastfeeding EducationHypnobreastfeeding Education |
| Control group | No intervention | –Control group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- High-risk primiparous pregnant women
- Those with 28-34 weeks of pregnancy
- Those who volunteered to participate in the study
- Those who can read and write Turkish
Key exclusion criteria (7 listed)
- Those with communication disabilities
- Those with psychiatric and mental illnesses
- Those who have an obstacle to breastfeeding
- Those who have previously attended a birth preparation class
- Those who receive breastfeeding-related training and consultancy
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 EducationMonitoring anxiety and breastfeeding intention in pregnancy, and assessing perception of insufficient milk supply, and breastfeeding adaptation in postpartum period | Behavioural | Experimental group |
Primary outcome
Anxiety Assessment Scale
Time frame: At the end of the 1 months
The minimum score that can be obtained from the scale is "10", the maximum score is "50", and as the score obtained from the scale increases, anxiety levels also increase.
Infant Feeding Intention Instrument
Time frame: At the end of the 1 months
The minimum score that can be obtained from the scale is "0", the maximum score is "16", and as the score obtained from the scale increases, intention to exclusively breastfeed the baby levels also increase.
2 secondary outcomes
Perception of Insufficient Milk Questionnaire
Time frame: Postpartum 24-48 hours, postpartum 2nd week and postpartum 4th week
Breastfeeding Adaptation Scale
Time frame: Postpartum 24-48 hours, postpartum 2nd week and postpartum 4th week
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 15 Dec 2025.
Related trials for High-risk Pregnancy
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Not yet recruitingPhase 2
Pucotenlimab, Lenvatinib, and SBRT Before Surgery for Localized Clear Cell Renal Cell Carcinoma
Localized Clear Cell Renal Cell Carcinoma
Recruiting
Unravelling Tumour Biology In Ovarian Cancer With Precision Imaging
High Grade Serous Ovarian Cancer
RecruitingPhase 2
Immunotherapy Platform Study in Platinum Resistant High Grade Serous Ovarian Cancer
Ovarian Cancer
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
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.
Emine İbici Akça, PhD principal investigator
Amasya 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 Hypnobreastfeeding Education in people with High-risk Pregnancy and Breast Feeding, run by Amasya 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 15 Dec 2025. 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?
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 Emine İbici Akça (+90 (358) 211 50 05, emine.akca@amasya.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety Assessment Scale (time frame: At the end of the 1 months). The study lists 2 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 Dec 2025.