EVALUATİON OF THE EFFECTİVENESS OF A MODEL-BASED HYPNOBREASTFEEDİNG EDUCATİON PROGRAM GİVEN TO PRİMİPAROUS PREGNANT WOMEN

EVALUATİON OF THE EFFECTİVENESS OF A HYPNOBREASTFEEDİNG EDUCATİON PROGRAM BASED ON THE INFORMATİON-MOTİVATİON-BEHAVİORAL SKİLLS (IMB) MODEL İN PRİMİPAROUS WOMEN

This randomized controlled trial aimed to evaluate the effectiveness of an education program based on the Information-Motivation-Behavioral Skills (IMB) Model and grounded in the philosophy of hypnobreastfeeding provided to primiparous pregnant women.

Study Overview

• Status: Enrolling by invitation
• Conditions: Pregnancy; Healthy Subjects; Breastfeeding; Hypno-breastfeeding Education; Healthy (Controls); Breastfeeding Self-Efficacy; Information Motivation Behavioral Skills Model; Breastfeeding Motivation
• Intervention / Treatment: Behavioral: breastfeeding education program based on hypnobreastfeeding philosophy

Detailed Description

Throughout her life, a woman experiences numerous physiological processes, one of the most significant of which is the breastfeeding period. Breastfeeding is the natural and normative method of infant feeding; however, it encompasses far more than nutrition alone. By influencing all vital life processes, breastfeeding lays the foundations of both physical and psychological health and establishes an instinctive, epigenetic connection between mother and infant. Breast milk and breastfeeding, which are regarded as the gold standard in infant nutrition, provide all essential nutrients and energy required to support infant growth and development. In addition to being easily digestible, breast milk has high bioavailability and constitutes a natural and optimal source of nutrition. Breast milk and breastfeeding offer numerous benefits for both infants and mothers. Breastfeeding strengthens the infant's immune system, supports brain development, contributes to the maturation of the respiratory system and immature intestines, and reduces the risk of allergic reactions. Furthermore, infants who are breastfed have a lower risk of developing obesity and diabetes later in life. The continuation of breastfeeding is mediated by various physical and biological changes that contribute to the multiple advantages breastfeeding provides to mothers. Lactation represents a unique biological phase characterized by hormonal regulation, suppression of reproductive functions, and metabolic adaptations. Breastfeeding is associated with a reduced risk of maternal anemia, osteoporosis, depression, and ovarian and breast cancers.

Breast milk and breastfeeding have been identified as global health priorities within the World Health Organization's (WHO) 2030 Sustainable Development Goals. Consequently, breastfeeding-related strategies have gained increasing importance in national development agendas. The primary factors contributing to this emphasis include the widespread availability of infant formula due to technological advancements, shifts in lifestyle and cultural practices, and changes in economic conditions. Supporting and sustaining breastfeeding through policy initiatives is therefore essential to achieving sustainable development goals, as suboptimal breastfeeding practices negatively affect infant and child health in the short term and public health in the long term.

Globally, while approximately 70% of infants are breastfed during the first year of life, this rate declines to 45% during the second year, indicating that sustained breastfeeding remains below desired levels worldwide. The WHO and the United Nations Children's Fund (UNICEF) recommend initiating breastfeeding within the first half hour after birth, exclusively breastfeeding for the first six months, and continuing breastfeeding alongside complementary feeding until at least two years of age and beyond. Despite these recommendations, WHO data indicate that a substantial proportion of newborns in many countries are still not breastfed within the first hour after birth. Between 2007 and 2014, only 36% of infants aged 0-6 months worldwide were exclusively breastfed, and this rate increased to 44% according to WHO data published in 2021.

Although breastfeeding is a common practice in Türkiye, breastfeeding rates show a decline similar to global trends. The rate of breastfeeding within the first 24 hours after birth has been reported as 85.6%. According to the 2013 Türkiye Demographic and Health Survey (TDHS), 96% of infants were breastfed at some point during infancy; however, exclusive breastfeeding rates declined from 58% during the first two months to 10% by the fourth and fifth months. TDHS 2018 data revealed that although 98% of infants born within the preceding two years were breastfed, only 73% were breastfed within the first hour after birth, 86% within the first day, and 24% received supplementary feeding prior to breastfeeding. Exclusive breastfeeding rates declined with infant age, decreasing from 59% at 0-1 months to 45% at 2-3 months and 14% at 4-5 months.

In Türkiye, declining breastfeeding rates have been attributed to maternal age, educational level, income status, availability of social support, obstetric factors, breastfeeding-related myths, and maternal health problems. Additionally, maternal feelings of inadequacy and lack of access to appropriate support when encountering breastfeeding difficulties adversely affect breastfeeding continuation. Psychological factors such as maternal perceptions of breastfeeding, self-confidence, breastfeeding motivation, and self-efficacy play a significant role in breastfeeding outcomes.

Breastfeeding self-efficacy refers to a mother's belief in her ability to breastfeed her infant successfully. This belief influences whether a mother initiates breastfeeding, the effort she invests, and her thoughts and emotions related to breastfeeding. Mothers who do not perceive breastfeeding as valuable or who lack confidence in their ability to breastfeed are less motivated and more likely to discontinue breastfeeding early. Therefore, understanding maternal motivation-the driving force behind behavior-is essential for identifying the reasons underlying early breastfeeding cessation.

Maternal motivation, a key determinant of breastfeeding self-efficacy, has been shown to influence maternal behaviors and exclusive breastfeeding practices during the first six months postpartum. Breastfeeding motivation is shaped by emotional state, attitudes toward breastfeeding, self-confidence, self-efficacy, and family and environmental factors. Consequently, pregnant women may experience ambivalence regarding breastfeeding. Motivational interviewing, frequently used to resolve ambivalence, aims to correct misconceptions, enhance motivation, and strengthen self-efficacy in breastfeeding practices. Studies have demonstrated that motivational interviewing improves breastfeeding self-efficacy, motivation, and exclusive breastfeeding duration.

During pregnancy and the postpartum period, both pharmacological and non-pharmacological methods are employed to increase prolactin secretion and breast milk production. These methods support the continuation of breastfeeding. Non-pharmacological approaches include frequent breastfeeding or pumping, massage and compression, warm applications, acupuncture and acupressure, aromatherapy, music therapy, yoga, hypnobreastfeeding, oxytocin massage, and structured education and counseling.

Hypnobreastfeeding is a mind-body approach that enhances bodily awareness, fosters self-compassion, increases maternal confidence, and emphasizes mother-infant cooperation while adopting an instinctive perspective focused on the natural process of breastfeeding. This philosophy incorporates relaxation, positive suggestions, breathing techniques, emotional regulation, stress reduction, and affirmative guidance related to the maternal role, thereby facilitating breastfeeding continuation.

Although studies on hypnobreastfeeding remain limited, available evidence suggests that hypnobreastfeeding interventions increase breast milk volume, reduce anxiety, accelerate colostrum secretion, elevate prolactin levels, and enhance breastfeeding self-efficacy and motivation.

Breastfeeding education and counseling are known to play a critical role in improving breastfeeding outcomes. Contemporary approaches emphasize structured, theory-based counseling models, one of which is the Information-Motivation-Behavioral Skills (IMB) Model. Developed by Fisher et al. in 1992, the IMB Model provides a robust theoretical framework for behavior change by addressing knowledge, motivation, and behavioral skills components. According to this model, deficiencies in any of these components may hinder the adoption of health-promoting behaviors.

While studies grounded in the IMB Model have demonstrated effectiveness across various health behaviors, research integrating hypnobreastfeeding philosophy with the IMB Model in breastfeeding education is lacking. Nurses play a pivotal role in supporting and sustaining breastfeeding; thus, employing structured, model-based approaches supported by innovative philosophies is essential. The integration of hypnobreastfeeding philosophy with the IMB Model constitutes the originality and scientific value of the present study.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Esenboğa
    • Ankara, Esenboğa, Turkey (Türkiye), 06010
      • Ankara Yildirim Beyazit Üniversitesi Esenboğa Külliyesi
  • Merkez
    • Sivas, Merkez, Turkey (Türkiye), 58140
      • Sivas Cumhuriyet Üniversitesi Sağlik Hizmetleri Uygulama Ve Araşturma Hastanesi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• • Aged 18 years or older,

  • At least primary school graduates,
  • Between 27 and 28 weeks of gestation,
  • Primiparous,
  • Without high-risk pregnancies (e.g., gestational diabetes, epilepsy, preeclampsia, multiple pregnancy, etc.),
  • Without pre-existing health conditions prior to pregnancy (e.g., diabetes mellitus, hypertension, renal failure, epilepsy, etc.),
  • Without diagnosed psychiatric disorders (e.g., anxiety, mood disorders, depression, bipolar disorder, etc.),
  • Willing to participate voluntarily in the prenatal education program,
  • Not previously enrolled in a structured breastfeeding education program,
  • Turkish-speaking and without any communication barriers (e.g., cognitive, hearing, or visual impairments),
  • Not a member of a health sciences profession, and
  • Having access to the internet, a computer, or a smartphone.

Exclusion Criteria:

• • Incomplete completion of data collection forms,

  • Withdrawal from participation in the study,
  • Failure of pregnant women in the intervention group to fully participate in the educational program,
  • Lack of internet access,
  • Prior participation in a structured breastfeeding education program,
  • Discontinuation of breastfeeding by the mother after delivery, and
  • Any circumstances that would prevent the breastfeeding process or require mother and infant to be separated.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INTERVENTION GROUP RECEIVING BREASTFEEDING EDUCATION BASED ON HYPNOBREASTFEEDING PHILOSOPHY; According to the BMD model, pregnant women who receive training based on the philosophy of hypnotherapy will be given breastfeeding education between the 28th and 32nd weeks of pregnancy. Before the training, pregnant women will be administered the TBF, HFEBF, and Prenatal Breastfeeding Self-Efficacy Scale. The program consists of two equal sessions totaling 240 minutes. At the 34th week of pregnancy, they will complete a post-test including the HFEBT, the Visual Analog Scale of Prenatal Breastfeeding Motivation, and the Prenatal Breastfeeding Self-Efficacy Scale. At the behavioral level of the model, the women's postpartum and breastfeeding processes will be assessed in the first 24-48 hours and 6-8 weeks after delivery using the Postnatal Observation Form, Breastfeeding Self-Efficacy and Motivation Assessment, and the Postnatal Breastfeeding Self-Efficacy Scale Breastfeeding Process Assessment Form.	Behavioral: breastfeeding education program based on hypnobreastfeeding philosophy; Hypnobreastfeeding training and counseling will be provided by a researcher with certifications in Mindfulness and Self-Compassion Skills Development. The Hypnobreastfeeding Philosophy-Based Breastfeeding Training Program is planned for weeks 28-32 of pregnancy.The training will cover topics such as 'My dream breastfeeding, meeting information needs related to breastfeeding'. The first training session will last a total of 120 minutes.The second training session will be held in week 30 of pregnancy. In the second training session, topics such as mulberry meditation for conscious breastfeeding, affirmations for breastfeeding and Dr. Masaru Emoto's "The Effect of Thoughts on Water Molecules" experiment, emotional awareness exercise, Alfred and his shadow: a short film about emotions, feelings and emotions related to breastfeeding and the relationship between hormones and emotions: oxytocin and endorphin massage will be covered.
No Intervention: CONTROL GROUP WHO HAVE NOT RECEIVED BREASTFEEDING TRAINING.; Interviews will be conducted with women aged 28-32 weeks in the waiting room of the Obstetrics and Gynecology Outpatient Clinic. Pregnant women will undergo face-to-face TBF, HFEBF, and Antenatal Breastfeeding Self-Efficacy Scale tests. No training will be provided to the control group. At 34 weeks of gestation, a post-test including HFEBT, the Visual Analog Scale of Antenatal Breastfeeding Motivation, and the Antenatal Breastfeeding Self-Efficacy Scale will be completed. At the behavioral level of the model, women's postpartum and breastfeeding processes will be assessed using the Postpartum Observation Form, Breastfeeding Self-Efficacy and Motivation Assessment, and the Postpartum Breastfeeding Self-Efficacy Scale Breastfeeding Process Assessment Form within the first 24-48 hours and 6-8 weeks after delivery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypnobreastfeeding Philosophy-Based Breastfeeding Knowledge Test (HFEBT)	This test was prepared based on the literature, consisting of 50 items with 'Yes', 'No', and 'I don't know' options. To evaluate the representational power, comprehensibility, and content validity of the items in the HFEBT's pool of correct and incorrect statements, the opinions of 11 experts were sought. Based on the expert opinions, KGO (Knowledge Confidence Level) values were calculated. The lower limit for evaluating the KGO of the items, within a 5% margin of error, is 0.636. In line with the feedback from the experts, 5 items with KGO below 0.59 were removed from the test. Based on these results, the final form of the knowledge test consists of a total of 45 questions (Min=0 - Max=45). As the average score obtained from the HFEBT increases, it will be assumed that mothers' knowledge level of breastfeeding based on the Hypnobreastfeeding philosophy increases (KR20=0.757).	4 month
Antenatal Breastfeeding Self-Efficacy Scale (EÖYÖ)	The Antenatal Breastfeeding Self-Efficacy Scale was developed by Dennis (2003) as a shortened version of the Breastfeeding Self-Efficacy Scale (BSES). He suggested that the shortened version could also be used during pregnancy by using the "future tense" expression in its items. Following this suggestion, future tense expressions were used in the scale items, and reliability and validity studies were conducted to create the antenatal version of the scale. The Turkish validity and reliability study of the scale was conducted by Aluş Tokat (2009). The scale consists of 14 items that assess breastfeeding self-efficacy and uses a 5-point Likert scale. The items are rated from 1 = "not sure at all" to 5 = "always sure". The lowest possible score is 14, and the highest is 70. A higher score on the scale indicates higher breastfeeding self-efficacy. The Cronbach alpha value of the Turkish version of the Antenatal Breastfeeding Self-Efficacy Scale was found to be 0.87 (Aluş Tokat, 2009).	4 month
Postnatal Breastfeeding Self-Efficacy Scale (EÖYÖ)	The Postnatal Breastfeeding Self-Efficacy Scale was developed by Dennis (2003) and is a shortened version of the Breastfeeding Self-Efficacy Scale (PSES). Dennis states that the scale is suitable for use in the postpartum period (Dennis, 2003). The Turkish validity and reliability study of the scale was conducted by Aluş Tokat (2009). The scale consists of 14 items that assess breastfeeding self-efficacy and is a 5-point Likert type scale. The items of the scale are evaluated by rating them from 1 = 'not sure at all' to 5 = 'always sure'. The lowest possible score is 14, and the highest is 70. A higher score on the scale indicates higher breastfeeding self-efficacy. The Cronbach's alpha value of the Postnatal PSES was found to be 0.86, indicating that the scale is suitable for Turkish culture (Aluş Tokat, 2009).	4 MONTH
Primiparous Breastfeeding Motivation Scale (PEMÖ)	This scale was developed by Stockdale et al. in 2013 to determine breastfeeding motivation in first-time mothers (Stockdale, et al., 2013). The Turkish validity and reliability study was conducted by Akçay. The scale consists of 29 items. It is a seven-point Likert-type scale with four sub-dimensions. These sub-dimensions are: - Value given to breastfeeding (items 1, 2, 4, 6, 8, 10, 12, 14, 15, 20, 24, 25, 28) - Self-efficacy (items 9, 16, 17, 18, 19, 26, 29) - Midwifery support (items 21, 22, 23, 27) - Expectation of success (items 3, 5, 7, 11, 13). As the score obtained from each sub-dimension increases, the level of breastfeeding motivation for that sub-dimension also increases. The Cronbach's Alpha reliability coefficient of the scale was determined as 0.884 for the breastfeeding dimension, 0.825 for the self-efficacy dimension, 0.686 for the parental support dimension, and 0.873 for the success expectation dimension (Akçay, 2019).	4 MONTH

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Demographic Information Form (TBF)	This questionnaire was prepared by the researcher after reviewing the relevant literature. The Demographic Information Form consists of 13 questions in total, divided into three sections (Altıparmak, 2021; Eryılmaz, 2022; Aslantaş, 2022; Sergek, 2023; Durmuş, 2023). The first section includes questions related to sociodemographic characteristics (age, education level, marital status, etc.). The second section includes questions related to pregnancy (gestational week, voluntary pregnancy, etc.). The third section includes a visual analog scale for the mother's breastfeeding motivation and a significance-confidence scale to assess the importance and self-confidence she places on breastfeeding.	4 MONTH
Postpartum Observation Form (PGF)	This form was prepared by the researcher after reviewing the relevant literature (Altıparmak, 2021; Eryılmaz, 2022; Aslantaş, 2022; Sergek, 2023; Durmuş, 2023). The postpartum observation form includes 10 questions evaluating the postpartum period and breastfeeding (such as gestational age at birth, type of delivery, and breastfeeding status). The form will be completed by the researcher using information obtained from patient files within the first 24-48 hours postpartum.	4 MONTH
Breastfeeding Process Evaluation Form (ESDF)	This form was prepared by the researcher after reviewing the relevant literature (Altıparmak, 2021; Eryılmaz, 2022; Aslantaş, 2022; Sergek, 2023; Durmuş, 2023). The Breastfeeding Process Assessment Form includes 13 questions (such as uninterrupted breastfeeding, duration of breastfeeding) that assess the breastfeeding process in the 6-8th week postpartum. The form was presented to five experts for their opinions. After the expert opinions, Kendall's W (inter-rater agreement and reliability) analysis was performed. The inter-rater agreement was found to be at a good level, Kendall's Wa = 0.224 (p=0.329).	4 MONTH

Collaborators and Investigators

• Sponsor: Ankara Yildirim Beyazıt University
• Investigators: Study Director: Sena KAPLAN, PROF, ataykaplan@yahoo.com; Study Director: GÖZDE GÖKÇE İSBİR, PROF, gozdegokce@gmail.com

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2025
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): August 14, 2026

Study Registration Dates

• First Submitted: March 2, 2026
• First Submitted That Met QC Criteria: March 7, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: breastfeeding self-efficacy; Hypno-breastfeeding; breastfeeding education; Information Motivation Behavioral Skills Model; breastfeeding motivation; breastfeeding philosophy
• Additional Relevant MeSH Terms: Behavior; Feeding Behavior; Breast Feeding
• Other Study ID Numbers: AnkaraYBU-SBF-BÖG-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No