Lactation Clinical Trial
Official title:
The Effect of Music Practice and Marmet Technique on Lactation and Maternal Anxiety in Mothers With Premature Babies: A Randomized Controlled Study
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.
Status | Not yet recruiting |
Enrollment | 66 |
Est. completion date | February 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Prof. Dr. Süleyman Yalçin City Hospital | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Resmiye KAYA ODABAS | Goztepe Training and Research Hospital, Usak University |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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. | |
Primary | 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 | Maternal Satisfaction Rating Scale | 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". | Post-intervention at 05:00 pm on the postoperative 4st day. |
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