NCT05211076

Brief Summary

This study was planned as a randomized controlled study to examine the effect of music practice and Marmet Technique on lactation and maternal anxiety in mothers with premature babies in the neonatal intensive care unit.The research will be carried out with 32+0 and 36+6 weeks old preterms hospitalized in the Suleyman Yalçin City Hospital NICU.It will be held between January and December 2022 with mothers of premature babies born by cesarean section between weeks of gestation.The research will be carried out with three groups as music,Marmet Technique and control group.The sample number was calculated using the G\*Power program and the music group:22,the Marmet Technique:22,and the control group: 22 (n=66).It is planned to collect the data with the Introductory Information Form, the Breast Milk Follow-up Form, the State Anxiety Scale and the Maternal Satisfaction Evaluation Scale.Post-op with mothers on day 8-12. Information about the research will be given by meeting between hours and written and verbal consent will be taken.Randomization will be applied to the mothers who accepted the study.During the study,all mothers will be informed that music and Marmet Technique will be performed at 11:00 and 17:00, 2 sessions a day for 4 days,starting from the post-op day 1,and then the milking process will be performed,and the mothers will be provided to come to the breastfeeding room at the specified times.The State Anxiety Scale will be filled in by the mother,and then the music will be played for 15 minutes.In the 16th minute,milking will be performed manually by the researcher and the milking process will take at least 15 minutes.After the milking process,the mother will fill the State Anxiety Scale again.In the Marmet Technique group,the State Anxiety Scale will be filled first by the mother,and then massage and milking will be performed for 20-30 minutes in accordance with the protocol of the technique.After the milking process,the mother will fill in the State Anxiety Scale again.No application will be made to the control group. Breast milk will be provided manually by the researcher for at least 15 minutes.The data of the research will be evaluated using the SPSS program.In the evaluation of the data;descriptive statistics will be done with One Way Analysis of Variance Kruskal Wallis H Test.In order to determine the difference in milk amounts between groups,repeated measure covariance analysis will be applied.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
1.9 years until next milestone

Study Start

First participant enrolled

January 8, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

March 8, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

January 12, 2022

Last Update Submit

March 7, 2023

Conditions

Keywords

lactationmarmet techniquemusic therapymaternal anxietybreast milknonpharmacological method

Outcome Measures

Primary Outcomes (24)

  • amount of breast milk

    The amount of breast milk will be expressed manually for at least 15 minutes until no milk comes out. At the end of the milking process, the amount of milk accumulated in the container will be measured by the researcher with an injector and recorded in the Breast Milk Follow-up Form in milliliters and delivered to the newborn midwife/nurse.

    On the 1st postoperative day, at 11:00 am.

  • amount of breast milk

    The amount of breast milk will be expressed manually for at least 15 minutes until no milk comes out. At the end of the milking process, the amount of milk accumulated in the container will be measured by the researcher with an injector and recorded in the Breast Milk Follow-up Form in milliliters and delivered to the newborn midwife/nurse.

    On the 1st postoperative day, at 05:00 pm.

  • amount of breast milk

    The amount of breast milk will be expressed manually for at least 15 minutes until no milk comes out. At the end of the milking process, the amount of milk accumulated in the container will be measured by the researcher with an injector and recorded in the Breast Milk Follow-up Form in milliliters and delivered to the newborn midwife/nurse.

    On the 2st postoperative day, at 11:00 am.

  • amount of breast milk

    The amount of breast milk will be expressed manually for at least 15 minutes until no milk comes out. At the end of the milking process, the amount of milk accumulated in the container will be measured by the researcher with an injector and recorded in the Breast Milk Follow-up Form in milliliters and delivered to the newborn midwife/nurse.

    On the 2st postoperative day, at 05:00 pm.

  • amount of breast milk

    The amount of breast milk will be expressed manually for at least 15 minutes until no milk comes out. At the end of the milking process, the amount of milk accumulated in the container will be measured by the researcher with an injector and recorded in the Breast Milk Follow-up Form in milliliters and delivered to the newborn midwife/nurse.

    On the 3st postoperative day, at 11:00 am.

  • amount of breast milk

    The amount of breast milk will be expressed manually for at least 15 minutes until no milk comes out. At the end of the milking process, the amount of milk accumulated in the container will be measured by the researcher with an injector and recorded in the Breast Milk Follow-up Form in milliliters and delivered to the newborn midwife/nurse.

    On the 3st postoperative day, at 05:00 pm.

  • amount of breast milk

    The amount of breast milk will be expressed manually for at least 15 minutes until no milk comes out. At the end of the milking process, the amount of milk accumulated in the container will be measured by the researcher with an injector and recorded in the Breast Milk Follow-up Form in milliliters and delivered to the newborn midwife/nurse.

    On the 4st postoperative day, at 11:00 am.

  • amount of breast milk

    The amount of breast milk will be expressed manually for at least 15 minutes until no milk comes out. At the end of the milking process, the amount of milk accumulated in the container will be measured by the researcher with an injector and recorded in the Breast Milk Follow-up Form in milliliters and delivered to the newborn midwife/nurse.

    On the 4st postoperative day, at 05:00 pm.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Pre-intervention at 11:00 am on the postoperative 1st day.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Post-intervention at 11:00 am on the postoperative 1st day.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Pre-intervention at 05:00 pm on the postoperative 1st day.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Post-intervention at 05:00 pm on the postoperative 1st day.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Pre-intervention at 11:00 am on the postoperative 2st day.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Post-intervention at 11:00 am on the postoperative 2st day.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Pre-intervention at 05:00 pm on the postoperative 2st day.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Post-intervention at 05:00 pm on the postoperative 2st day.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Pre-intervention at 11:00 am on the postoperative 3st day.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Post-intervention at 11:00 am on the postoperative 3st day.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Pre-intervention at 05:00 pm on the postoperative 3st day.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Post-intervention at 05:00 pm on the postoperative 3st day.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Pre-intervention at 11:00 am on the postoperative 4st day.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Post-intervention at 11:00 am on the postoperative 4st day.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Pre-intervention at 05:00 pm on the postoperative 4st day.

  • State Anxiety Scale

    The scale, which consists of 20 questions in total, determines how the individual feels at the moment. Behaviors and emotions expressed in the items of the scale are marked as (1) none, (2) a little, (3) a lot, and (4) completely (Öner \& Le Compte, 1983). A total score is obtained and an evaluation is made over a minimum of 20 and a maximum of 80 points. In addition, there are reversed and direct/straight statements in the scale, and a 4 point answer in direct statements indicates high anxiety. In reversed statements, answers with 1 point indicate a high level of anxiety. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 are reversed statements. In these items, 1 point is given 4 points, 2 points 3 points, 3 points 2 points, 4 points 1 point. In the scoring of the scale, the level of anxiety increases as the scores increase, and 20 is considered the lowest level of anxiety and 80 the highest level of anxiety.

    Post-intervention at 05:00 pm on the postoperative 4st day.

Secondary Outcomes (1)

  • Maternal Satisfaction Rating Scale

    Post-intervention at 05:00 pm on the postoperative 4st day.

Study Arms (3)

Music Group

EXPERIMENTAL

In the selection of the music to be played,Rast,Uşşak,Kürdi,Muhayyer modes were chosen by taking expert opinion.Before starting the music application,the selected music will be sent to the mothers in this group by the researcher over the internet to the mother's phone and it will be ensured that the mother listens to the music transmitting the sound from her own phone in each session. * Music practice will take place in mothers' rooms or in the NICU. * The room will be quiet and your mother will be alone. * To make the mother listen to music;The mother will be asked to sit on the bed/seat in a comfortable position. * At the same time,the mother will be asked to close her eyes and be relaxed. * Later, music will be turned on from the mother's phone, allowing the mother to listen to music for 30 minutes * While the mother listening to the music,at the 16th minute of the music,researcher will manually express each breast separately for at least 15 minutes until no milk comes out

Other: Music Group

Marmet Technique Group

EXPERIMENTAL

Marmet Technique is one of the non-pharmacological methods used to increase milk production.The Marmet Technique is a combined method that includes breast massage and manual milking.The Marmet Technique will be performed in the mothers' rooms or in the Breastfeeding Room of the Neonatal Intensive Care Unit. It will be ensured that the mother is comfortable by paying attention to her privacy. Mothers will be manually milked into the hopper in their own milking set. In addition, the reservoir will be used after washing with hot water. This technique consists of two stages, these stages are emptying the milk ducts and stimulating the milk stroke reflex (massage).

Other: Marmet Technique Group

control group

EXPERIMENTAL

On the other hand, no application will be made to the control group, and the milking process will be carried out manually by the researcher for at least 15 minutes until the milk does not come.

Other: Control group

Interventions

The Introductory Information Form will be filled in by researcher using face-to-face interview technique.It will be ensured that the mother fills the State Anxiety Scale with her own statement.On the 1st day of the post-op,mothers will be able to listen to Classical Turkish Music works in the forms of Saz Semaisi,Peşrev,Medhal in Rast,Uşşak,Kürdi,Muhayyer makams for 30 minutes via their phone at 11:00am. While the mother continues to listen to the music,at the 16th minute,the researcher will manually milk the mother for at least 15 minutes until milk comes out.At the end of the milking process,the milk accumulated in the container will be measured by the researcher with injector,recorded in the Breast Milk Follow-up Form.At the end of the music session,it will be ensured that the mother fills in the State Anxiety Scale with her own statement. The same procedure will be applied to the mother atb05:00pm.This process will be carried out 8 times in total,at 11:00am and 05:00pm for 4days.

Music Group

Consent will be obtained from those who agree to participate in the study. The Introductory Information Form will be filled by the researcher using face-to-face interview technique. It will be ensured that the mother fills the State Anxiety Scale with her own statement. The Marmet Technique will be applied to the mothers at 11:00am for 20-30 minutes by the researcher. At the end of the milking process performed in accordance with the technique, the milk accumulated in the container will be measured with an injector and recorded in the Breast Milk Follow-up Form. Then, it will be ensured that the mother fills in the State Anxiety Scale with her own statement. At 05:00pm, the same procedure will be applied to the mother. At the end of the 4th day, the satisfaction of the mother will be evaluated on the Mother Satisfaction Evaluation Scale.This process will be carried out 8 times in total,at 11:00am and 05:00pm for 4days.

Marmet Technique Group

The Introductory Information Form will be filled by the researcher using face-to-face interview technique.It will be ensured that the mother fills the State Anxiety Scale with her own statement.The mothers will milk the mother manually by the researcher at 11:00am for at least 15 minutes until the milk does not come. At the end of the milking process, the milk accumulated in the container will be measured with an injector and recorded in the Breast Milk Follow-up Form in ml. Then, it will be ensured that the mother fills in the State Anxiety Scale with her own statement. At 05:00pm, the same procedure will be applied to the mother. At the end of the 4th day, the satisfaction of the mother will be evaluated on the Mother Satisfaction Evaluation Scale.This process will be carried out 8 times in total,at 11:00am and 05:00pm for 4days.

control group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • In the 18-35 age range,
  • Primiparous and multiparous,
  • Birth by cesarean section between 32+0 and 36+6 gestational weeks,
  • The baby is hospitalized in the Neonatal Intensive Care Unit,
  • Babies who cannot be breastfed, but fed and tolerated by gavage,
  • Willing to feed their baby with breast milk,
  • Able to speak and understand Turkish,
  • The mothers who agreed to participate in the study

You may not qualify if:

  • Having advanced congenital anomaly in her baby,
  • Babies with contraindications for breastfeeding (galactosemia, congenital anomalies, etc.),
  • Having any health problems (tuberculosis, HIV, cancer, etc.),
  • Having multiple pregnancies,
  • Body mass index over 30,
  • Those who became pregnant with infertility treatment,
  • Using drugs to increase breast milk, vitamins and additional supplements,
  • Having postpartum complications (bleeding, embolism, etc.),
  • The baby and/or own Covid-19 positive,
  • Mothers who smoke or drink alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Süleyman Yalçın City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Hüsnü Fahri OVALI, Prof. Dr.

    Goztepe Training and Research Hospital

    PRINCIPAL INVESTIGATOR
  • Ayla ERGİN, Ass.Prof.

    Kocaeli University

    STUDY DIRECTOR
  • Şeyma ÇATALGÖL, Instructor

    Uşak University

    STUDY CHAIR
  • Ebru Aktaş, Midwifery

    Goztepe Training and Research Hospital

    STUDY CHAIR

Central Study Contacts

Resmiye KAYA ODABAŞ, Res. Ass.

CONTACT

Ayla ERGİN, Ass.Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2022

First Posted

January 27, 2022

Study Start

January 8, 2024

Primary Completion

December 1, 2024

Study Completion

February 1, 2025

Last Updated

March 8, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations