- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07528001
Hypno-Breastfeeding Education and Postpartum Outcomes
The Effect of Hypno-Breastfeeding-Based Education on Postpartum Anxiety, Self-Compassion, Breastfeeding Motivation, and Breastfeeding Self-Efficacy: A Randomized Controlled Trial
This randomized controlled trial aims to examine the effects of hypno-breastfeeding-based education on postpartum anxiety, self-compassion, breastfeeding motivation, and breastfeeding self-efficacy among mothers in the early postpartum period. The postpartum period is a critical phase characterized by significant physical and psychological changes. Primiparous mothers, in particular, may experience anxiety, lack of confidence, and reduced motivation for breastfeeding, which may negatively affect breastfeeding success and mother-infant bonding.
The study will be conducted with 102 primiparous mothers aged 18-40 years within the first 72 hours postpartum. Participants will be randomly assigned to intervention and control groups. The intervention group will receive hypno-breastfeeding-based education, while the control group will receive routine care. The educational program includes principles of hypnosis, breastfeeding knowledge, anxiety management, self-efficacy enhancement, and self-awareness techniques, supported by guided relaxation, breathing exercises, and positive suggestion methods.
Data will be collected using validated scales, including the Postpartum-Specific Anxiety Scale, Self-Compassion Scale, Breastfeeding Motivation Scale, and Breastfeeding Self-Efficacy Scale. Appropriate statistical analyses will be performed.
The findings are expected to contribute to the development of psychoeducational nursing interventions, reduce postpartum anxiety, improve breastfeeding outcomes, and strengthen maternal adaptation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized controlled trial is designed to evaluate the effects of hypno-breastfeeding-based education on postpartum anxiety, self-compassion, breastfeeding motivation, and breastfeeding self-efficacy in the early postpartum period. The postpartum period is a critical phase in which women undergo significant physiological recovery as well as psychological and social adaptation to motherhood. Primiparous mothers, in particular, frequently experience anxiety, perceived inadequacy, stress, and concerns related to breastfeeding, which may negatively affect breastfeeding practices and mother-infant bonding.
Postpartum anxiety is a significant psychological factor influencing maternal confidence, caregiving ability, and adaptation to breastfeeding. Breastfeeding motivation and self-efficacy are key determinants of successful initiation and continuation of breastfeeding. Mothers with higher self-efficacy tend to demonstrate greater persistence, lower anxiety levels, and more successful breastfeeding outcomes. In addition, self-compassion is considered a protective psychological construct that enhances emotional regulation and resilience by promoting self-kindness and reducing self-criticism.
Hypnosis-based approaches focus on accessing subconscious processes to promote relaxation, mental awareness, and positive cognitive restructuring. Previous studies have demonstrated the effectiveness of hypnosis in reducing anxiety, managing stress, and improving psychological well-being. However, there is limited evidence regarding the integration of hypnosis into breastfeeding-focused nursing interventions. Therefore, hypno-breastfeeding represents an innovative and holistic approach that may influence both psychological and behavioral outcomes in the postpartum period.
The study will be conducted at Zeynep Kamil Women's and Children's Training and Research Hospital in Istanbul. The sample will consist of 102 primiparous mothers aged 18-40 years within the first 72 hours postpartum. Participants will be randomly assigned to intervention and control groups. The intervention group will receive hypno-breastfeeding education, while the control group will receive routine care only.
The intervention consists of three sessions, each lasting approximately 60 minutes. The first session focuses on the fundamentals of hypnosis, the importance of breastfeeding, and correct breastfeeding techniques. The second session addresses postpartum anxiety, anxiety management, and hypnosis-based techniques to enhance self-efficacy. The third session emphasizes self-awareness, positive suggestion, and coping strategies for breastfeeding-related challenges. Guided relaxation, breathing exercises, and suggestion techniques are integrated throughout all sessions.
Data will be collected at baseline and post-intervention using validated instruments, including the Postpartum-Specific Anxiety Scale, Self-Compassion Scale, Breastfeeding Motivation Scale, and Breastfeeding Self-Efficacy Scale. Statistical analyses will be conducted using SPSS software, including descriptive statistics and appropriate comparative tests to evaluate within-group and between-group differences.
The findings of this study are expected to contribute to the development of psychoeducational nursing interventions, support maternal psychological well-being, improve breastfeeding outcomes, and strengthen mother-infant bonding. Furthermore, the study provides a novel interdisciplinary model integrating women's health and psychiatric nursing perspectives.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Beyzanur İşbay Aydemir, Msc
- Phone Number: +905456078994
- Email: bisbay94@hotmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primiparous mothers Aged between 18-40 years Within the first 72 hours postpartum Having a singleton birth Staying in the same room with the newborn (rooming-in) No medical condition preventing breastfeeding No chronic disease or pregnancy-related complications Did not receive breastfeeding education during pregnancy Able to understand and speak Turkish Willing to participate and provide informed consent
Exclusion Criteria:
- Use of medications that interfere with breastfeeding Having a newborn admitted to the neonatal intensive care unit Diagnosed psychiatric disorder or use of psychiatric medication Participation in less than 80% of the intervention sessions Withdrawal from the study at any stage
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hypno-Breastfeeding Education
The experimental group will receive hypno-breastfeeding-based education designed to reduce postpartum anxiety and improve breastfeeding outcomes.
The intervention consists of three sessions, each lasting approximately 60 minutes, including hypnosis-based relaxation techniques, breathing exercises, positive suggestion methods, and education on breastfeeding practices, anxiety management, self-awareness, and self-efficacy.
The sessions will be delivered during the early postpartum period.
|
The intervention consists of a structured hypno-breastfeeding-based educational program designed specifically for primiparous mothers in the early postpartum period. This program integrates principles of hypnosis with breastfeeding education to address both psychological and behavioral aspects of breastfeeding. The intervention is delivered in three sessions, each lasting approximately 60 minutes. The first session focuses on the fundamentals of hypnosis, the importance of breastfeeding, and correct breastfeeding techniques. The second session addresses postpartum anxiety, psychological factors affecting breastfeeding, and hypnosis-based methods to enhance self-efficacy. The third session focuses on self-awareness, development of positive behavioral patterns, and coping strategies for breastfeeding challenges. |
|
No Intervention: Routine Care (Control Group)
The control group will receive routine postpartum care without any additional educational intervention during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postpartum Anxiety
Time Frame: 1 month
|
Measured using the Postpartum-Specific Anxiety Scale (PSAS) to evaluate changes in anxiety levels among mothers.
Assessments will be conducted at baseline (within the first 72 hours postpartum) and after the intervention.
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-Compassion
Time Frame: 1 month
|
Measured using the Self-Compassion Scale to assess changes in mothers' self-kindness, mindfulness, and emotional regulation levels at baseline and post-intervention.
|
1 month
|
|
Breastfeeding Motivation
Time Frame: 1 month
|
Measured using the Breastfeeding Motivation Scale to evaluate mothers' willingness and psychological readiness to initiate and maintain breastfeeding.
|
1 month
|
|
Breastfeeding Self-Efficacy
Time Frame: 1 month
|
Measured using the Breastfeeding Self-Efficacy Scale to assess mothers' confidence in their ability to successfully breastfeed.
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Beyzanur İşbay Aydemir, Msc, İstanbul Aydın Üniversitesi
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Hypno-Breastfeeding
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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