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The Effect of Music Practice and Marmet Technique on Lactation and Maternal Anxiety in Mothers With Premature Babies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05211076
Recruitment Status : Recruiting
First Posted : January 27, 2022
Last Update Posted : June 1, 2022
Sponsor:
Collaborators:
Goztepe Training and Research Hospital
Uşak University
Information provided by (Responsible Party):
Resmiye KAYA ODABAŞ, Kocaeli University

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.

Condition or disease Intervention/treatment Phase
Lactation Other: Music Group Other: Marmet Technique Group Other: Control group Not Applicable

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Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Music Practice and Marmet Technique on Lactation and Maternal Anxiety in Mothers With Premature Babies: A Randomized Controlled Study
Actual Study Start Date : January 8, 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : February 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Music Group

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

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.


Experimental: Marmet Technique Group
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

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.


Experimental: control group
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

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.





Primary Outcome Measures :
  1. amount of breast milk [ Time Frame: On the 1st postoperative day, at 11:00 am. ]

    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.


  2. amount of breast milk [ Time Frame: On the 1st postoperative day, at 05:00 pm. ]

    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.


  3. amount of breast milk [ Time Frame: On the 2st postoperative day, at 11:00 am. ]

    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.


  4. amount of breast milk [ Time Frame: On the 2st postoperative day, at 05:00 pm. ]

    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.


  5. amount of breast milk [ Time Frame: On the 3st postoperative day, at 11:00 am. ]

    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.


  6. amount of breast milk [ Time Frame: On the 3st postoperative day, at 05:00 pm. ]

    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.


  7. amount of breast milk [ Time Frame: On the 4st postoperative day, at 11:00 am. ]

    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.


  8. amount of breast milk [ Time Frame: On the 4st postoperative day, at 05:00 pm. ]

    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.


  9. State Anxiety Scale [ Time Frame: Pre-intervention at 11:00 am on the postoperative 1st day. ]
    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.

  10. State Anxiety Scale [ Time Frame: Post-intervention at 11:00 am on the postoperative 1st day. ]
    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.

  11. State Anxiety Scale [ Time Frame: Pre-intervention at 05:00 pm on the postoperative 1st day. ]
    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.

  12. State Anxiety Scale [ Time Frame: Post-intervention at 05:00 pm on the postoperative 1st day. ]
    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.

  13. State Anxiety Scale [ Time Frame: Pre-intervention at 11:00 am on the postoperative 2st day. ]
    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.

  14. State Anxiety Scale [ Time Frame: Post-intervention at 11:00 am on the postoperative 2st day. ]
    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.

  15. State Anxiety Scale [ Time Frame: Pre-intervention at 05:00 pm on the postoperative 2st day. ]
    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.

  16. State Anxiety Scale [ Time Frame: Post-intervention at 05:00 pm on the postoperative 2st day. ]
    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.

  17. State Anxiety Scale [ Time Frame: Pre-intervention at 11:00 am on the postoperative 3st day. ]
    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.

  18. State Anxiety Scale [ Time Frame: Post-intervention at 11:00 am on the postoperative 3st day. ]
    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.

  19. State Anxiety Scale [ Time Frame: Pre-intervention at 05:00 pm on the postoperative 3st day. ]
    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.

  20. State Anxiety Scale [ Time Frame: Post-intervention at 05:00 pm on the postoperative 3st day. ]
    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.

  21. State Anxiety Scale [ Time Frame: Pre-intervention at 11:00 am on the postoperative 4st day. ]
    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.

  22. State Anxiety Scale [ Time Frame: Post-intervention at 11:00 am on the postoperative 4st day. ]
    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.

  23. State Anxiety Scale [ Time Frame: Pre-intervention at 05:00 pm on the postoperative 4st day. ]
    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.

  24. State Anxiety Scale [ Time Frame: Post-intervention at 05:00 pm on the postoperative 4st day. ]
    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.


Secondary Outcome Measures :
  1. Maternal Satisfaction Rating Scale [ Time Frame: Post-intervention at 05:00 pm on the postoperative 4st day. ]
    In this scale prepared by the researchers, it was aimed to evaluate the satisfaction of the mothers regarding the practices performed by scoring between 0-10. 0: "Not at all satisfied" and 10: "Very satisfied".



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05211076


Contacts
Layout table for location contacts
Contact: Resmiye KAYA ODABAŞ, Res. Ass. +90 544 648 99 34 resmiye.odabas@gmail.com
Contact: Ayla ERGİN, Ass.Prof. +90 532 723 19 53 ayla.ergn@gmail.com

Locations
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Turkey
Prof. Dr. Süleyman Yalçın City Hospital Recruiting
İstanbul, Turkey
Contact: Ebru AKTAŞ, Midwifery    +90535 879 1580    ebruaktas.eak@gmail.com   
Sponsors and Collaborators
Resmiye KAYA ODABAŞ
Goztepe Training and Research Hospital
Uşak University
Investigators
Layout table for investigator information
Principal Investigator: Hüsnü Fahri OVALI, Prof. Dr. Goztepe Training and Research Hospital
Study Director: Ayla ERGİN, Ass.Prof. Kocaeli University
Study Chair: Şeyma ÇATALGÖL, Instructor Uşak University
Study Chair: Ebru Aktaş, Midwifery Goztepe Training and Research Hospital
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Responsible Party: Resmiye KAYA ODABAŞ, Principal Investigator, Kocaeli University
ClinicalTrials.gov Identifier: NCT05211076    
Other Study ID Numbers: resmiye-0001
First Posted: January 27, 2022    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Resmiye KAYA ODABAŞ, Kocaeli University:
lactation
marmet technique
music therapy
maternal anxiety
breast milk
nonpharmacological method
Additional relevant MeSH terms:
Layout table for MeSH terms
Premature Birth
Anxiety Disorders
Mental Disorders
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications