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

NCT07461428 | Enrolling By Invitation

• 1 other identifier: AnkaraYBU-SBF-BÖG-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Healthy Subjects; Healthy (Controls); Pregnancy; Breastfeeding; Breastfeeding Self-Efficacy; Hypno-breastfeeding Education; Information Motivation Behavioral Skills Model; Breastfeeding Motivation

Keywords

Hypno-breastfeeding; breastfeeding education; breastfeeding self-efficacy; breastfeeding motivation; breastfeeding philosophy; Information Motivation Behavioral Skills Model

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• The Demographic Information Form (TBF)

  4 MONTH

• Postpartum Observation Form (PGF)

  4 MONTH

• Breastfeeding Process Evaluation Form (ESDF)

  4 MONTH

Study Arms (2)

INTERVENTION GROUP RECEIVING BREASTFEEDING EDUCATION BASED ON HYPNOBREASTFEEDING PHILOSOPHY

EXPERIMENTAL

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

CONTROL GROUP WHO HAVE NOT RECEIVED BREASTFEEDING TRAINING.

NO INTERVENTION

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.

Interventions

breastfeeding education program based on hypnobreastfeeding philosophy BEHAVIORAL

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.

INTERVENTION GROUP RECEIVING BREASTFEEDING EDUCATION BASED ON HYPNOBREASTFEEDING PHILOSOPHY

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: PRİMİPAR PREGNANCY
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (2)

Ankara Yildirim Beyazit Üniversitesi Esenboğa Külliyesi

Ankara, Esenboğa, 06010, Turkey (Türkiye)

Location

Sivas Cumhuriyet Üniversitesi Sağlik Hizmetleri Uygulama Ve Araşturma Hastanesi

Sivas, Merkez, 58140, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Sena KAPLAN, PROF

  ataykaplan@yahoo.com

  STUDY DIRECTOR

• GÖZDE GÖKÇE İSBİR, PROF

  gozdegokce@gmail.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding is a methodological procedure in randomized controlled trials in which one or more individuals involved in the study remain unaware of participants' group assignments, specifically which group is the intervention and which is the control (Akın \& Koçoğlu, 2017). In the present study, statistical analyses will be performed under blinded conditions to minimize potential bias. Prior to the analysis, all participant data were anonymized, and group assignments were coded as 'A' for the intervention group and 'B' for the control group. These coded datasets were then provided to the statistician. The actual group identities will only be disclosed after the completion of all statistical analyses. Group assignment for each participant is determined according to the randomization list, which is applied only after the participant's enrollment in the study has been confirmed.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD STUDENT

Model Details: INTERVENTION GROUP RECEIVING BREASTFEEDING TRAINING BASED ON HYPNOBREASING PHILOSOPHY, AND CONTROL GROUP NOT RECEIVING TRAINING.

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 10, 2026
• Study Start: May 20, 2025
• Primary Completion (Estimated): August 14, 2026
• Study Completion (Estimated): August 14, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)