AzTrials
AzTrials

StressBRESTINNCT06876051

Breastfeeding, Early Prenatal Stress Intervention, and Infant Neurodevelopment

A study testing Relaxation & Breastfeeding Education and Active comparator in people with Stress and Relaxation, run by National and Kapodistrian University of Athens at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trial is to determine whether antenatal maternal stress management using relaxation techniques improves breastfeeding effectiveness and neonatal neurodevelopmental outcomes. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Stress, Relaxation, Breastfeeding
What is being tested?
Relaxation & Breastfeeding Education and Active comparator
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
1 siteGreece
Study dates
1 Feb 2018to 10 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primiparous pregnant women
  • 14-20 weeks of Gestational Age
  • Intention to give birth at the specific maternity hospital
  • Greek women or foreigners who know the Greek language very well
  • Place of residence: Greece

Who cannot join

  • Use of benzodiazepines, major neuroleptics, or psychostimulant medications.
  • Pregnant women diagnosed with incurable physical or mental diseases.
  • Pregnant women carrying fetuses or newborns with major congenital anomalies or criteria for perinatal asphyxia.
  • Pregnant women with stillbirths or newborns who do not survive.
  • All mothers and their newborns born before 34 weeks of gestation or requiring hospitalization in the Neonatal Intensive Care Unit (NICU) for more than 7 days.

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Maternity Hospital "ELENA VENIZELOU"

    Athens, Attica, 11521

Other trials in Greece

About this study

Official title: The Impact of Prenatal Stress Management Program on Maternal Breastfeeding and Neonatal Neurodevelopmental Parameters

The goal of this clinical trial is to determine whether antenatal maternal stress management using relaxation techniques improves breastfeeding effectiveness and neonatal neurodevelopmental outcomes. It is hypothesized that reducing maternal stress during pregnancy will enhance the initiation and continuation of exclusive breastfeeding until six months postpartum.

The management of antenatal maternal stress is expected to be reflected in both the newborn's behavior and proteins associated with neurodevelopment, such as Brain-Derived Neurotrophic Factor (BDNF) and Reelin.

Read more

The main research questions of this study include the following:

  1. Does stress management in pregnant women using relaxation techniques increase the likelihood of exclusive breastfeeding at one and six months postpartum?
  2. Does it impact neonatal and infant growth and behavior?
  3. Does it alter neurotrophin levels in the fetus? This trial will provide insight into the potential benefits of prenatal stress reduction for both maternal and infant health outcomes.
  4. "If prenatal stress management leads to changes in neurotrophins in the fetus, could these changes be linked to the success and duration of breastfeeding, as well as the infant's growth and behavior?
Read the detailed description

METHODOLOGY Researchers will compare three groups of pregnant women who will receive three different types of information during pregnancy.

  • The first group, or intervention group (IG), will be trained in 8-10 structured individual sessions of relaxation techniques that they will apply throughout the pregnancy, along with structured information about breastfeeding.
  • The second group, or Active Control group (ACG), will receive 8 individual structured educational courses about breastfeeding, childbirth and the needs of the newborn, and
  • The third group, or Control Group (CG), will receive a standard use information provided by the hospital midwife stuff about childbirth and breastfeeding in 3-4 group meetings .

Participants will be primipara pregnant women native speaking of the Greek language and they will be included in the study after randomization based on the electronic system random.org , between the 15th and 20th week of gestation They will be studied in 4 time periods (phases) .

  • The first phase, will be prenatally at the beginning of the study between 15th -20th week of gestation,
  • the second phase, will be prenatally at the end of the study between the 34th and 36th week of gestation,
  • the third phase, will be in the first month after childbirth and
  • the fourth phase, will be in the 6th month of their baby's life. The study as well, will include the newborns of the participants in the third and fourth phase of the study, corresponding them to the group of their mothers.

Comparisons will be in each group and between the groups investigating the alteration of stress, anxiety and depression during the four time periods pre and postnatally . Concurrently the change in the belief of successful breastfeeding during the two first periods of time (phase 1 and 2 ) , prenatally, will be compared with the real outcome at the phase 3 and 4.

For each participant, the following data will be recorded:

Phases 1 and 2:

  1. Demographic data
  2. Pregnancy stress, assessed using the Prenatal Experience Brief Scale
  3. Pregnancy anxiety, assessed using the Pregnancy Anxiety Questionnaire
  4. Prenatal breastfeeding self-efficacy, assessed using the Prenatal e. Breastfeeding Self-Efficacy Scale

Phases 1, 2, 3, and 4:

  1. Perceived stress, assessed using the Perceived Stress Scale-14 (PSS-14)
  2. Postpartum depression, assessed using the Edinburgh Postpartum Depression Scale (EPDS)
  3. Anxiety, assessed using the Spielberger State-Trait Anxiety Inventory (STAI)

Phases 3 and 4:

  1. Breastfeeding self-efficacy, assessed using the Breastfeeding Self-Efficacy Scale
  2. Breastfeeding-related questions from the Pregnancy Risk Assessment Monitoring System (PRAMS) of the CDC

Phase 4 only :

  1. Maternal attachment, assessed using the Maternal Attachment Scale
  2. Infant behavior, assessed using the Infant Behavior Questionnaire

For each newborn, the following data will be recorded:

  1. Anthropometric measurements at birth (3rd phase) and at six months of age (4th phase).
  2. Neonatal behavior, assessed between the 4th and 7th day of life (3rd phase) using the Neonatal Behavioral Assessment Scale (NBAS). The evaluation will be conducted by a healthcare professional trained and familiar with the use of this specific behavioral assessment tool.
  3. Developmental milestones at six months of age (4th phase).
  4. Infant behavior assessment at six months of age (4th phase), conducted using the Infant Behavior Questionnaire, which will be completed by the parents based on their own observations and assessment

Biological Markers Collection and Analysis

The collection of biological markers is structured according to the study phase:

  • In phases 1 and 2, salivary cortisol will be measured in pregnant participants. Participants will be asked to collect saliva using Salivettes (Sarstedt), following specific instructions provided by the manufacturer.
  • In phases 1 and 3, maternal serum neurotrophins (BDNF and Reelin) will be analyzed. Additionally, in phase 3, umbilical cord serum neurotrophins will be measured.

Saliva Collection and Analysis

Saliva collection will be conducted at four time points throughout the day to assess the circadian rhythm of each pregnant participant:

  • Morning, immediately upon awakening
  • 30 minutes after awakening
  • Afternoon, before lunch (around 3:00 PM)
  • Night, before bedtime (around 12:00 AM) Pregnant participants will store the collected samples in the refrigerator until they bring them to the laboratory the following day. At the laboratory, the samples will undergo centrifugation followed by measurement using Chromatography/Mass Spectrometry.. The saliva samples will be centrifuged for 2 minutes at 1,000 × g, following the manufacturer's instructions.

Neurotrophin Measurement (BDNF \& Reelin) - Phases 1 and 3

The measurement of BDNF and Reelin neurotrophins will be performed on serum blood samples collected at three time points:

  1. Phase 1: At the start of the intervention (between 15-20 weeks of gestation) - maternal blood serum.
  2. Phase 3: Before delivery (at hospital admission, marking the end of the prenatal intervention) - maternal blood serum.
  3. Phase 3: During delivery - umbilical cord serum only. All blood samples will undergo centrifugation at 3500 rpm for 5-6 minutes. The separated serum will then be transferred into Eppendorf tubes and stored at -80°C until further analysis. Neurotrophin levels (BDNF \& Reelin) will be measured using the ELISA method.
Being tested
Relaxation & Breastfeeding Education, Active comparator, control group
Keywords
breastfeeding, BDNF, Reelin, pregnancy, relaxation techniques, stress management
Medical subject headings
Breast Feeding, Infant Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Relaxation & Breastfeeding EducationBehavioural

    Also called Prenatal relaxation techniques, prenatal stress management, prenatal educational breastfeeding programme, diaphragmatic breathing

    Pregnant women in this group will be trained in 10 individual interactive sessions, focusing on relaxation techniques and breastfeeding including:

    1. Diaphragmatic breathing
    2. Progressive muscle relaxation (PMR) - tailored for pregnant women.
    3. Guided imagery
    4. the analysis of the concept of stress and stress management strategies for pregnancy including Cognitive-behavioral approach (CBT principles)
    5. Mindfulness-based pregnancy adaptation including positive thinking and wellbeing during pregnancy .
    6. Pregnancy stages.
    7. Benefits of breastfeeding.
    8. Breastfeeding guide and practical applications.
    9. Labor stages and childbirth preparation.
    10. Newborn and infant needs at home Every relaxation technique training will last 20 minutes practice in every session Additionally pregnant women will be practiced at least 3 times weekly during pregnancy

  • Active comparatorBehavioural

    Also called prenatal Breastfeeding Education, Infant cues on breastfeeding, breastmilk benefits, breastfeeding guide

    Participants in this group will receive only interactive online education, focusing exclusively on breastfeeding and newborn care. The Programme included ten remote sessions:

    1. Pregnancy stages.
    2. Benefits of breastfeeding.
    3. Skin-to-skin contact and rooming-in during the first days.
    4. The role of breastfeeding in maternal emotional well-being.
    5. Breastfeeding guide and practical applications.
    6. Maternal nutrition during breastfeeding.
    7. Common breastfeeding challenges.
    8. The father's role in breastfeeding support.
    9. Labor stages and childbirth preparation
    10. Newborn and infant needs at home.

  • control groupOther

    Also called Routine Maternity Care, Baby Friendly Hospital Initiative

    This group will received only standard prenatal and postnatal care at a Baby-Friendly Hospital, which adheres to WHO and UNICEF guidelines for breastfeeding support. They did not participate in additional structured educational programs or relaxation training.

Study groups in NCT06876051
Study groupRoleWhat they receive
Behavioral: Relaxation & Breastfeeding EducationExperimentalParticipants in the intervention group (primiparous pregnant women) receive: 1. Training in relaxation techniques, including guided breathing exercises, progressive muscle relaxation, and visualization methods. 2. Breastfeeding education, covering topics such as proper latching, milk production, and infant feeding schedules. The intervention consists of 8-10 structured sessions, beginning in the second trimester (gestational weeks 15-20) and continuing until the 36th week of gestation. Sessions are conducted in a structured format by trained professionals.
Receives: Behavioral: Relaxation & Breastfeeding Education
Behavioral : Breastfeeding Education AloneActive comparatorParticipants in the Active Comparator group receive 8-10 individual lessons covering: Pregnancy education, Breastfeeding techniques and best practices, Childbirth preparation, Newborn care essentials, Understanding infant cues and responses. These sessions are delivered in a structured format by trained professionals. No relaxation techniques are included in this intervention.
Receives: Behavioral: Active comparator
Standard Maternity Care (Control Group)OtherParticipants in the control group receive only the standard maternity care provided by health services during pregnancy. The maternity hospital is designated as a Baby-Friendly Hospital and follows its established guidelines and principles. Standard care includes routine prenatal check-ups and general health services. The hospital also offers psycho-prophylactic preparation for normal childbirth and one breastfeeding course, both led by midwife trainers. No additional intervention, such as relaxation techniques or structured breastfeeding education, is provided to this group.
Receives: Other: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prenatal Breastfeeding Self-Efficacy Across Study Groups

    This outcome will assess maternal confidence in breastfeeding and actual breastfeeding before childbirth using the Prenatal Breastfeeding Self-Efficacy Scale (PBSES), a validated tool that measures prenatal maternal perceived ability to breastfeed successfully. The PBSES consists of 20 items rated on a 5-point Likert scale, with a SUM score ranging from 20 (minimum) to 100 (maximum). Scores will be recorded without a cutoff point, with higher scores indicating greater prenatal maternal confidence in breastfeeding. Comparisons will be conducted among the three study groups to evaluate differences in PBSES scores based on the intervention received.

    Statistical analysis will include the comparisons across study groups using ANOVA or non-parametric equivalents. Regression models to explore potential predictors of higher or lower prenatal self-efficacy.

    Measured: 1) between 15 - 20 week of gestation and 2) between 35-38 weeks gestation before child birth

  2. Breastfeeding Self-Efficacy across the study groups and the time frames

    Maternal breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale (BSES), a validated questionnaire measuring maternal confidence in breastfeeding. The BSES consists of 14 items, each rated on a 5-point scale (1 = Strongly Disagree, 5 = Strongly Agree). The final score is calculated as the sum of all item scores, with higher scores indicating greater breastfeeding self-efficacy. Minimum Value is 14 (lowest BSES score) and Maximum Value is70 (highest BSES score) Comparative analyses will be conducted across the three study groups to evaluate differences in self-efficacy levels.

    Measured: At 1 and 6 months postpartum

  3. Breastfeeding Outcomes Across Study Groups

    Breastfeeding outcomes will be derived from responses to selected PRAMS questions, which indirectly indicate exclusivity. Breastfeeding success will be numerically categorized (1 = Exclusive breastfeeding, 2 = Any breastfeeding, 3 = No breastfeeding) to allow for statistical comparison with Breastfeeding Self-Efficacy Scale (BSES) scores. The analysis will examine whether higher BSES scores are associated with exclusive or any breastfeeding.

    Measured: at 1 and 6 Months Postpartum

  4. Neurotrophin Levels as Neurodevelopmental Parameters in Maternal Serum and Umbilical Cord Blood across the study groups

    The levels of neurotrophins, specifically brain-derived neurotrophic factor (BDNF) and Reelin, will be assessed as neurodevelopmental biomarkers in maternal serum at 15-20 weeks and 36-37 weeks of gestation, and in umbilical cord blood at birth.

    Neurotrophin quantification will be performed using the Enzyme-Linked Immunosorbent Assay (ELISA) method, following standardized protocols.

    Results will be expressed in picograms per milliliter (pg/mL), and comparative analyses will be conducted to evaluate differences across the three study groups and at different time points.

    Measured: In Maternal serum: 1) between the 15th -20th weeks of gestation and 2) at 36-37 weeks of gestation .Additionally Neurotrophins will be measured In Umbilical cord blood: At birth

  5. Neonatal Behavioral Assessment Across Study Groups

    Neonatal behavior will be assessed using the Neonatal Behavioral Assessment Scale (NBAS), conducted by a personnel trained in administering and scoring the instrumental tool . NBAS contains a large number of individual items scored on a 9-point scale and reflexes scored on a 4-point scale . The evaluated items will be categorized into eight clusters, with scores representing the mean of the item scores within each cluster. The clusters and the number of items per cluster are: 1. Habituation (4 items) , 2. Social -Interactive (7 items) , 3. Motor System (5 items), 4. State Organization(4 items), 5. State Regulation (4 items), 6. Autonomic System (3 items) , 7. Reflexes (18 items), 8. Supplementary Items (7 items)-Additional behavioral observations.

    Measured: 4-7 days postpartum

  6. Infant Behavioral Assessment Across Study Groups

    Infant behavior will be assessed using the Infant Behavior Questionnaire-Revised Short Form (IBQ-R SF), completed by parents. The IBQ-R SF consists of 91 items, each rated on a 7-point Likert scale (1 = Never, 7 = Always). Scores are averaged within each of the 14 behavioral subscales, which are further grouped into three broad temperament dimensions. The final score for each subscale or dimension is calculated as the mean of the corresponding item scores, providing a standardized numerical measurement of infant temperament for comparative analyses across the three study groups.

    Measured: IBQ-R SF will be measured at 6 months postpartum

Secondary outcomes (16)

  1. Correlation Between Maternal age and Breastfeeding success

    This outcome measure will assess the correlation between maternal age (in years) and breastfeeding success across the three study groups.

    Breastfeeding success will be categorized as:

    1. = No breastfeeding
    2. = Any breastfeeding
    3. = Exclusive breastfeeding Data will be collected using structured PRAMS-based questions.

    Statistical analysis:

    Pearson's or Spearman's correlation coefficient (r-value) will be used to assess the relationship between maternal age and breastfeeding success.

    Chi-square tests (χ²) will be used for categorical comparisons.

    Multivariate regression analysis will adjust for potential confounders.Unit of Measure:

    Maternal age: Years (continuous variable) Breastfeeding success: Categorical classification (1, 2, 3)

    Higher Scores Mean:

    For maternal age: Not applicable (continuous variable) For breastfeeding success: Higher values (3) indicate better outcomes (exclusive breastfeeding)

    Measured: breastfeeding outcomes : at 1 and 6 month postpartum.

  2. Correlation Between Maternal Socioeconomic Status and Breastfeeding success

    This outcome measure will assess the correlation between household income and breastfeeding success across the three study groups. Household income will be categorized into six levels based on self-reported data collected between the 15th and 20th week of gestation: 1 = Indigent, 2 = <10,000, 3 = 10,000-20,000, 4 = 20,000-30,000, 5 = 30,000-40,000, and 6 = >40,000. Breastfeeding success will be categorized as 1 = No breastfeeding, 2 = Any breastfeeding, and 3 = Exclusive breastfeeding, based on structured PRAMS-based questions. Statistical analysis will include Spearman's correlation coefficient (r-value) to assess the relationship between household income and breastfeeding success. Chi-square tests (χ²) will be used for categorical comparisons, and multivariate regression analysis for potential confounders. Unit of Measure: Household income will be recorded as an ordinal variable (1-6), and breastfeeding success as a categorical variable (1-3)

    Measured: Household income will be assessed between the 15th and 20th week of gestation, while breastfeeding outcomes will be measured at 1 and 6 months postpartum.

  3. correlation of maternal Body Mass Index (BMI) and Breastfeeding success across the three study groups.

    Maternal BMI will be calculated as weight (kg) divided by height squared (m²) and recorded at two time points: before pregnancy (self-reported) and at the time of delivery (measured clinically). Maternal BMI: kg/m²

    Breastfeeding success will be assessed using structured PRAMS-based questions, categorizing success as 1 = No breastfeeding, 2 = Any breastfeeding, 3 = Exclusive breastfeeding. Statistical analyses will assess correlations between maternal BMI and breastfeeding outcomes using Spearman's or Pearson's correlation coefficients, while regression models will adjust for confounders such as maternal age, socioeconomic status, and delivery mode.

    Measured: BMI assessment: Pre-pregnancy (self-reported) and at delivery (clinically measured) Breastfeeding outcomes assessment: 1 and 6 months postpartum

  4. Correlation Between Anxiety and Breastfeeding success

    Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), a validated self-report questionnaire measuring state and trait anxiety, with each subscale consisting of 20 items rated on a 4-point Likert scale, leading to a SUM score range of 20-80 per subscale.

    Breastfeeding success will be categorized using PRAMS-based structured questions as 1 = No breastfeeding, 2 = Any breastfeeding, 3 = Exclusive breastfeeding. Statistical analyses will assess correlations between STAI scores and breastfeeding success using Spearman's or Pearson's correlation coefficients, while regression models will adjust for confounders such as maternal age, socioeconomic status, and delivery mode.

    Measured: STAI assessment: prenatally at 15-20 and 35-38 weeks of gestation . Postnatally, Breastfeeding outcomes assessment: at 1 and 6 months postpartum.

  5. Correlation Between Pregnancy-Related Anxiety (PRAQ-R2) and Breastfeeding Success across study groups

    Pregnancy-related anxiety will be assessed using the Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2), a validated self-report questionnaire consisting of 11 items rated on a 5-point Likert scale (1 = Not at all relevant, 5 = Completely relevant), resulting in a SUM score ranging from 11 (lowest anxiety) to 55 (highest anxiety).

    Breastfeeding success will be categorized using PRAMS-based structured questionnaires as 1 = No breastfeeding, 2 = Any breastfeeding, 3 = Exclusive breastfeeding. Statistical analyses will assess correlations between PRAQ-R2 scores and breastfeeding success using Spearman's or Pearson's correlation coefficients, while regression models will adjust for confounders such as maternal age, socioeconomic status, and delivery mode.

    Measured: PRAQ-R2 assessment: Between 15-20 and 35-38 weeks of gestation Breastfeeding outcomes assessment: 1 and 6 months postpartum

  6. Influence of Neonatal Behavior on Breastfeeding Outcomes

    This outcome measure examines how neonatal behavior influences breastfeeding success across study groups. Neonatal behavior will be assessed using the Neonatal Behavioral Assessment Scale (NBAS) between the 3rd and 7th day postpartum, evaluating responses to stimuli, alertness, and sucking reflex. Breastfeeding success will be categorized as exclusive, partial, or no breastfeeding, based on structured breastfeeding questionnaires. Additional data will capture early neonatal feeding behaviors, such as skin-to-skin contact, first latch attempts, and initial feeding difficulties. Comparative analyses will assess differences between study groups, while correlation and regression models will explore whether more adaptive neonatal behaviors are associated with higher breastfeeding success rates.

    Measured: NBAS is evaluating between the first 4-7 days of life. Breastfeeding assessment will be at 1 and 6 months postpartum

  7. Correlation Between Neurotrophin Levels and Breastfeeding Self-Efficacy across the study groups

    This outcome measure examines the correlation between neurotrophin levels (BDNF, Reelin) and maternal breastfeeding self-efficacy across the three study groups. Neurotrophin levels will be measured in maternal serum and in umbilical cord blood using ELISA (pg/mL). Breastfeeding self-efficacy will be measured using the Breastfeeding Self-Efficacy Scale (BSES) with SUM score (Range: 14-70) Statistical analyses will include Spearman's or Pearson's correlation coefficients, with regression models adjusting for confounders.

    Measured: Neurotrophin levels: Maternal serum (15-20 and 36-37 weeks gestation), Umbilical cord blood (at birth) Breastfeeding self-efficacy: 1 and 6 months postpartum

  8. Correlation between Prenatal Breastfeeding Self-Efficacy and Breastfeeding Outcomes Across Study Groups

    Maternal breastfeeding self-efficacy will be assessed prenatally using the Prenatal Breastfeeding Self-efficacy Scale (PBSES), consisting of 20 items rated on a 5-point Likert scale (SUM score range: 20-100), to assess maternal confidence in breastfeeding during pregnancy. There are no cut-off points. As the scores get higher, the prenatal breastfeeding self-efficacy increases. Breastfeeding success will be categorized numerically as: 1 = No breastfeeding , 2 = Any breastfeeding, 3 = Exclusive breastfeeding. Statistical analyses will examine correlations between prenatal breastfeeding self-efficacy, and breastfeeding success.

    For PBSES: Higher scores indicate greater prenatal breastfeeding For breastfeeding success: Higher values indicate greater breastfeeding success.

    Measured: PBSES assessment: 15-20 weeks and 35-38 weeks of gestation Breastfeeding outcomes assessment: 1 and 6 months postpartum

  9. Correlation between Postnatal Breastfeeding Self-Efficacy and Breastfeeding Outcomes Across Study Groups

    Postnatal breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale (BSES), a validated questionnaire consisting of 14 items rated on a 5-point Likert scale (SUM score range: 14-70).

    Breastfeeding outcomes will be evaluated using structured PRAMS-based questions, categorizing success as 1 = No breastfeeding, 2 = Any breastfeeding, 3 = Exclusive breastfeeding. Statistical analyses will assess correlations between postnatal BSES scores and breastfeeding outcomes using Spearman's or Pearson's correlation coefficients, while regression models will adjust for confounders.

    Measured: BSES assessment: 1 and 6 months postpartum Breastfeeding outcomes assessment: 1 and 6 months postpartum

  10. Correlation between Salivary Cortisol levels and Breastfeeding outcomes across the study groups

    Salivary cortisol will be measured prenatally, using Salivette (Sarstedt) devices and analyzed via Chromatography/Mass Spectrometry (nmol/L).

    Breastfeeding outcomes will be evaluated using structured PRAMS-based questions, categorizing success as 1 = No breastfeeding, 2 = Any breastfeeding, 3 = Exclusive breastfeeding. Statistical analyses will assess correlations between prenatal maternal cortisol levels and breastfeeding outcomes using Spearman's or Pearson's correlation coefficients, while regression models will adjust for confounders.

    Measured: Salivary cortisol levels at 35-38 week of gestation . Breastfeeding success at 1 month postpartum

  11. Correlation Between Infant Behavior and Breastfeeding Success across the three study groups

    Infant behavior will be assessed at 6 months postpartum using the Infant Behavior Questionnaire-Revised Short Form (IBQ-R SF), a validated parental-report measure of temperament. Breastfeeding success will be categorized as 1 = No breastfeeding, 2 = Partial breastfeeding, 3 = Exclusive breastfeeding, based on structured breastfeeding questionnaires. Unit of Measure: IBQ-R SF score: Mean score per subscale (temperament domains) Breastfeeding success: Categorical classification (1 = No breastfeeding, 2 = Partial breastfeeding, 3 = Exclusive breastfeeding) Statistical analyses will assess correlations between IBQ-R SF scores and breastfeeding success using Spearman's or Pearson's correlation coefficients, while regression models will adjust for confounders.

    Measured: IBQ-R SF assessment: 6 months postpartum Breastfeeding outcomes assessment: 6 months postpartum

  12. correlation between newborn hospitalization and breastfeeding success across the study groups

    This outcome measure examines the correlation between neonatal hospitalization (Yes/No) and breastfeeding success across the three study groups. Neonatal hospitalization will be defined as admission to the Neonatal Intensive Care Unit (NICU) or other specialized care units after birth, and recorded as a binary variable (Yes = 1, No = 0).

    Breastfeeding success will be categorized based on structured PRAMS-based questions as 1 = No breastfeeding, 2 = Any breastfeeding, 3 = Exclusive breastfeeding. Statistical analyses will assess associations between neonatal hospitalization and breastfeeding success using Chi-square tests (χ²) for categorical comparisons, while logistic regression models will adjust for potential confounders such as gestational age, birth weight, and maternal health factors. For neonatal hospitalization: Not applicable (binary variable) For breastfeeding success: Higher values indicate greater breastfeeding success

    Measured: Neonatal hospitalization assessment: At birth Breastfeeding outcomes assessment: 1 and 6 months postpartum

  13. Correlation of Breastfeeding difficulties and postpartum breastfeeding support with breastfeeding success across the study groups

    Breastfeeding difficulties will be assessed using 11 PRAMS-based questions, where each item is answered as Yes (2) or No (1), resulting in a SUM score ranging from 11 (minimum difficulties) to 22 (maximum difficulties).

    Postpartum breastfeeding support from maternity hospital staff will be evaluated using 12 PRAMS-based questions, where each item is answered as Yes (2) or No (1), leading to a SUM score ranging from 12 (lowest support) to 24 (highest support).

    Breastfeeding success will be categorized based on PRAMS-based structured questionnaires, as 1 = No breastfeeding, 2 = Any breastfeeding, 3 = Exclusive breastfeeding. Statistical analyses will assess correlations between breastfeeding difficulties, postpartum support, and breastfeeding success using Spearman's or Pearson's correlation coefficients, while regression models will adjust for confounders such as maternal age, socioeconomic status, and delivery mode.

    Measured: Assessment of breastfeeding difficulties and postpartum support: 4 days postpartum Breaffeidng success at 1 and 6 months after birth

  14. Correlation Between Mode of Delivery and Breastfeeding Success across the study groups

    This outcome measure examines the correlation between mode of delivery and breastfeeding success across the three study groups. Mode of delivery will be categorized as follows:

    1 = Cesarean section 2 = Vaginal delivery 3 = Vaginal delivery with induction 4 = Induction attempted for vaginal delivery but resulted in cesarean section 5 = Cesarean section with general anesthesia 6 = Emergency cesarean section Breastfeeding success will be categorized using PRAMS-based structured questionnaires as 1 = No breastfeeding, 2 = Any breastfeeding, 3 = Exclusive breastfeeding. Statistical analyses will assess correlations between mode of delivery and breastfeeding success using Spearman's or Pearson's correlation coefficients, while logistic regression models will adjust for confounders such as maternal age, socioeconomic status, and gestational age at birth.

    Units of Measure are Mode of delivery: Categorical classification (1-6) Breastfeeding success: Categorical classification (1 - 3)

    Measured: Mode of delivery assessment: At birth Breastfeeding outcomes assessment: 1 and 6 months postpartum

  15. Correlation Between Postpartum Depression (EPDS) and Breastfeeding Success across the study groups

    Postpartum depression symptoms will be assessed using the Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report questionnaire, where each item is rated on a 4-point Likert scale (0-3), resulting in a SUM score ranging from 0 (no depressive symptoms) to 30 (severe depressive symptoms). Cutoff point will be 10 .

    Breastfeeding success will be categorized using PRAMS-based structured questionnaires as 1 = No breastfeeding, 2 = Any breastfeeding, 3 = Exclusive breastfeeding. Statistical analyses will assess correlations between EPDS scores and breastfeeding success using Spearman's or Pearson's correlation coefficients, while regression models will adjust for confounders such as maternal age, socioeconomic status, and mode of delivery.

    Measured: EPDS assessment: postnatally 1 and 6 months postpartum nad prenatally at 35-38 week of gestation Breastfeeding outcomes assessment: 1 and 6 months postpartum

  16. Correlation Between Stressful Life Events (Holmes and Rahe Stress Scale) and Breastfeeding Success

    Stressful life events will be assessed using the Holmes and Rahe Stress Scale, a validated tool that assigns weighted scores to 43 life events during the last year based on their relative stress impact. The total score is calculated as a SUM score, with higher values indicating greater exposure to stress and increased health risk. Breastfeeding success will be categorized using PRAMS-based structured questionnaires as 1 = No breastfeeding, 2 = Any breastfeeding, 3 = Exclusive breastfeeding. Statistical analyses will assess correlations between Holmes and Rahe Stress Scale scores and breastfeeding success using Spearman's or Pearson's correlation coefficients, while regression models will adjust for confounders such as maternal age, socioeconomic status, and mode of delivery.Unit of Measure: Holmes and Rahe Stress Scale score: SUM score (higher values indicate greater exposure to stress) and Breastfeeding success: Categorical classification (1-3)

    Measured: Assessment of stressful life events: During pregnancy for the last year . Breastfeeding outcomes assessment: 1 and 6 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2025
  2. Study start1 Feb 2018
  3. Primary completion15 Dec 2023
  4. Study completion10 Sep 2024

Resources

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
Model description
Primipara Pregnant women are randomly assigned to one of three groups: (1) an intervention group receiving relaxation techniques combined with breastfeeding education, (2) an active control group receiving only breastfeeding education, and (3) a control group receiving standard maternity care.
Masking
None (open label)
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06876051
Sponsor's protocol ID
1617031875 / 04-07-17
Other IDs
ID 126/04-09-17, 1617031875/2017
Acronym
BRESTIN
Status last verified
Mar 2025
First submitted
9 Feb 2025
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) collected during this study will not be shared with other researchers outside the study team. The data will be used exclusively for statistical analysis by the designated statistician. Data access will remain restricted until the completion, approval, and first official publication of the doctoral dissertation at the university.

Publications

  • Liang IJ. The wonders of mind-body practices during pregnancy: A topical review. Taiwan J Obstet Gynecol. 2024 Jul;63(4):486-491. doi: 10.1016/j.tjog.2024.04.007.

    PubMed 39004474

  • Alshammari M, Lee RLT, Stubbs M, Chan SW. Effectiveness of psychoeducation interventions for pregnant women with gestational diabetes mellitus: an integrative review. BMC Public Health. 2024 Oct 22;24(1):2929. doi: 10.1186/s12889-024-20428-6.

    PubMed 39438847

  • D'Angelo A, Ceccanti M, Petrella C, Greco A, Tirassa P, Rosso P, Ralli M, Ferraguti G, Fiore M, Messina MP. Role of neurotrophins in pregnancy, delivery and postpartum. Eur J Obstet Gynecol Reprod Biol. 2020 Apr;247:32-41. doi: 10.1016/j.ejogrb.2020.01.046. Epub 2020 Jan 30.

    PubMed 32058187

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Questions about this trial

What is this clinical trial studying?

A study testing Relaxation & Breastfeeding Education and Active comparator in people with Stress and Relaxation, run by National and Kapodistrian University of Athens at 1 site in Greece.

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 5 inclusion and 5 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: finished, as of the sponsor's last update on 10 Aug 2026. 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 Greece. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prenatal Breastfeeding Self-Efficacy Across Study Groups (time frame: 1) between 15 - 20 week of gestation and 2) between 35-38 weeks gestation before child birth). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06876051, which also lists 31 linked publications.

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 10 Aug 2026.

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