Clinical trial NCT05211076: The Effect of Music Practice and Marmet Technique on Lactation and Maternal Anxiety in Mothers With Premature Babies
Official title: The Effect of Music Practice and Marmet Technique on Lactation and Maternal Anxiety in Mothers With Premature Babies: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lactation
Keywords: lactation
marmet technique
music therapy
maternal anxiety
breast milk
nonpharmacological method
Lead sponsor: Kocaeli University
Sponsor class: OTHER
Collaborators: name: Goztepe Training and Research Hospital
name: Uşak University
First posted: 2022-01-27
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Primary aim: The primary purpose of the study is to examine the effects of music practice and Marmet Technique on lactation and maternal anxiety in mothers with premature babies.

Secondary aim: The secondary aim of the research is to contribute to the literature on music practice and Marmet Technique.

Hypotheses:

H0: There is no difference in the amount of breast milk between the music, Marmet Technique and control groups in mothers with premature babies in the neonatal intensive care unit.

H1: There is a difference in the amount of breast milk between the music, Marmet Technique and control groups in mothers with premature babies in the neonatal intensive care unit.

H0: There is no difference in maternal anxiety between music, Marmet Technique and control groups in mothers with premature babies in the neonatal intensive care unit.

H1: There is a difference in maternal anxiety between music, Marmet Technique and control groups in mothers with premature babies in the neonatal intensive care unit.

This study was designed as a randomized controlled experimental study. The study was conducted at the Suleyman Yalçin City Hospital from January to December 2022.

The universe of the research is Göztepe Prof. Dr. 32+0- and 36+6 patients hospitalized in the Newborn Intensive Care Unit of Suleyman Yalçin City Hospital. Mothers of premature babies born before the week of gestation will form. The research will be carried out with three groups as music, Marmet Technique and control group. Sample size, according to to examine the effect of listening to music on postpartum depression and lactation. The sample size of the study was calculated using the G\*Power 3.1.9.2 program and the mean, standard deviation and sample size values of the breast milk variable included in the related article were taken into account in calculating the effect size. In the music group, the mean and standard deviation values of the breast milk variable were 60.50±25.30 and n=30. In the control group, the mean and standard deviation values of the breast milk variable were 31.30±22.60 and n=30. Using the mean, standard deviation and sample number values of the related article, the mean standard deviation value was found to be 23.98, and as a result, the effect size was calculated as 0.60. The minimum number of individuals to be included in the sample of this study was calculated by taking G\*Power 3.1.9.2 and f: 0.60, α= 0.05, 1-β: 0.95, and the sample size was determined as at least 45 mother (15 mother for each group). In order to increase the analysis power, the number of samples was increased and n=22 was taken for each group (music group: 22, marmet technique group: 22 and control group: 22). In which group the mothers included in the study will be, will be determined from the website of the random number generation program "Research Lists", and they will be divided into three groups.

Randomization: The group that the mothers will be in is determined from the random number generation website called "Random Lists". The mothers were divided into three groups as the music group, the Marmet Technique group and the control group. Thus, each mother's number will be determined and recorded.

Research data, Descriptive Information Research data, Descriptive Information Form, Breast Milk Follow-up Form, State Anxiety Scale and Maternal Satisfaction Evaluation Scale will be collected.

Introductory Information Form: This form was prepared by the researchers in line with the literature.There are 26 questions in the form, including socio-demographic (5), obstetric characteristics (5), general health information (7), characteristics related to breast milk and breastfeeding (4), and newborn characteristics (5).

Breast Milk Follow-up Form: For each day, in this form prepared by the researchers; Information about the time elapsed since the last milking, the duration of milking, the amount of milk expressed, the daily sleep duration of the mother and the amount of fluid consumed by the mother are included.

State Anxiety Inventory: 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. 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 as the lowest level of anxiety and 80 as the highest level of anxiety.

Maternal Satisfaction Evaluation Scale: In this scale, which was prepared by the researchers, it was aimed to evaluate the satisfaction of mothers regarding the practices performed by scoring between 0-10. It is expressed as 0: "Not at all satisfied" and 10: "Very satisfied, satisfied".

Preliminary work will be done with five mothers before starting the study in order to assess whether the questions have been understood. As a result of the evaluation, it will be evaluated whether there is a need for editing in the data forms and adjustments will be made. Those included in the pilot application will not be included in the sample group.

Data Collection In order to carry out the study, after obtaining the permission of the ethics committee and the institution, the mothers who performed cesarean section will be met on the 0th post-op day by going to the institution. The mothers who meet the research criteria will be informed about the purpose, content and methods of the research and those who want to participate in the study will be determined. Then, in which group the mothers will be, they will be divided into three groups as music, Marmet Technique and control group through the random number generation program "Random Lists". Thus, each mother's number will be determined and recorded. Verbal and written consent will be obtained from those who accept the study. Since the mothers had pain on the post-op day 0, it is planned to start the study at 11:00 on the post-op 1st day.

In the study, the data will be filled in by the researcher working as a midwife in the Neonatal Intensive Care Unit in the same hospital, by face-to-face interview technique in the Breastfeeding Room of the Neonatal Intensive Care Unit. During the study, all mothers will be informed that music practice and Marmet Technique will be performed at 11:00 and 17:00, 2 sessions a day (8 sessions in total) for 4 days, and then the milking process will be performed, and it will be ensured that the mothers come to the breastfeeding room at the specified times. Depending on the mother's condition, the application and milking process will be carried out in the patient's room during the hospitalization, or in the Breastfeeding Room of the Neonatal Intensive Care Unit for those who can come to the breastfeeding room.

First of all, the State Anxiety Scale for the music group will be filled by the mother and then the music will be played for 15 minutes. While the music continues, milking will be performed manually by the researcher at the 16th minute and the milking process will take at least 15 minutes (music listening time will take 30 minutes in total). After the milking process, it will be ensured that the mother fills in the State Anxiety Scale again. In the Marmet technique group, the State Anxiety Scale will be filled by the mother first, 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 have to fill in the State Anxiety Scale again. On the other hand, no application will be made to the control group, and milking will be performed manually by the researcher for at least 15 minutes until the milk does not come.

It will be ensured that the mother completes the State Anxiety Scale before and after the milking process. Applications and milking process,

1. st day 2 times,
2. st day 2 times,
3. st day 2 times,
4. st day 2 times, The milking process will be carried out by performing music and Marmet Technique separately for each group, 8 times in total. No application will be made to the control group, and only the milking process and the filling of the forms will be carried out.

Eligibility 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

Primary outcomes:
measure: amount of breast milk
timeFrame: On the 1st postoperative day, at 11:00 am.
measure: amount of breast milk
timeFrame: On the 1st postoperative day, at 05:00 pm.
measure: amount of breast milk
timeFrame: On the 2st postoperative day, at 11:00 am.
measure: amount of breast milk
timeFrame: On the 2st postoperative day, at 05:00 pm.
measure: amount of breast milk
timeFrame: On the 3st postoperative day, at 11:00 am.
measure: amount of breast milk
timeFrame: On the 3st postoperative day, at 05:00 pm.
measure: amount of breast milk
timeFrame: On the 4st postoperative day, at 11:00 am.
measure: amount of breast milk
timeFrame: On the 4st postoperative day, at 05:00 pm.
measure: State Anxiety Scale
timeFrame: Pre-intervention at 11:00 am on the postoperative 1st day.
measure: State Anxiety Scale
timeFrame: Post-intervention at 11:00 am on the postoperative 1st day.
measure: State Anxiety Scale
timeFrame: Pre-intervention at 05:00 pm on the postoperative 1st day.
measure: State Anxiety Scale
timeFrame: Post-intervention at 05:00 pm on the postoperative 1st day.
measure: State Anxiety Scale
timeFrame: Pre-intervention at 11:00 am on the postoperative 2st day.
measure: State Anxiety Scale
timeFrame: Post-intervention at 11:00 am on the postoperative 2st day.
measure: State Anxiety Scale
timeFrame: Pre-intervention at 05:00 pm on the postoperative 2st day.
measure: State Anxiety Scale
timeFrame: Post-intervention at 05:00 pm on the postoperative 2st day.
measure: State Anxiety Scale
timeFrame: Pre-intervention at 11:00 am on the postoperative 3st day.
measure: State Anxiety Scale
timeFrame: Post-intervention at 11:00 am on the postoperative 3st day.
measure: State Anxiety Scale
timeFrame: Pre-intervention at 05:00 pm on the postoperative 3st day.
measure: State Anxiety Scale
timeFrame: Post-intervention at 05:00 pm on the postoperative 3st day.
measure: State Anxiety Scale
timeFrame: Pre-intervention at 11:00 am on the postoperative 4st day.
measure: State Anxiety Scale
timeFrame: Post-intervention at 11:00 am on the postoperative 4st day.
measure: State Anxiety Scale
timeFrame: Pre-intervention at 05:00 pm on the postoperative 4st day.
measure: State Anxiety Scale
timeFrame: Post-intervention at 05:00 pm on the postoperative 4st day.
Secondary outcomes:
measure: Maternal Satisfaction Rating Scale
timeFrame: Post-intervention at 05:00 pm on the postoperative 4st day.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Prof. Dr. Süleyman Yalçın City Hospital
Study officials:
affiliation: Goztepe Training and Research Hospital
name: Hüsnü Fahri OVALI, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kocaeli University
name: Ayla ERGİN, Ass.Prof.
role: STUDY_DIRECTOR
affiliation: Uşak University
name: Şeyma ÇATALGÖL, Instructor
role: STUDY_CHAIR
affiliation: Goztepe Training and Research Hospital
name: Ebru Aktaş, Midwifery
role: STUDY_CHAIR
References: