Effect of Hypnobreastfeeding Education in High-Risk Pregnant Women

December 1, 2025 updated by: Amasya University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey (Türkiye)
      • Amasya, Turkey (Türkiye), 05000
        • Recruiting
        • Amasya University
        • Contact:
          • Emine İBİCİ AKÇA
          • Phone Number: 0 358 211 50 05

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Experimental: Experimental group
Hypnobreastfeeding Education
Behavioral: Hypnobreastfeeding Education
Monitoring anxiety and breastfeeding intention in pregnancy, and assessing perception of insufficient milk supply, and breastfeeding adaptation in postpartum period

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At the end of the 1 months
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.
At the end of the 1 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Perception of Insufficient Milk Questionnaire
Time Frame: Postpartum 24-48 hours, postpartum 2nd week and postpartum 4th week
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.
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
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.
Postpartum 24-48 hours, postpartum 2nd week and postpartum 4th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amasya University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emine İbici Akça, PhD, Amasya University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025000162

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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