Nonpharmacological Methods and Lactation
Condition: Lactation
Study type: Interventional

Summary: 
      Primiparous mothers after cesarean section often encounter insufficient milk production
      during breastfeeding. This study was planned as a randomized controlled study to examine the
      effect of acupressure and back massage on lactation in cesarean deliveries. The research will
      be carried out between July 2021 and July 2023 with mothers who had a cesarean section at
      Kocaeli University Research and Application Hospital and Health Sciences University Derince
      Training and Research Hospital. The research will be carried out with three groups as
      acupressure, back massage and control group. The sample number was calculated using the
      G*Power 3.1.9.2 program and the acupressure group: 24, the back massage group: 24, and the
      control group: 24. In order to increase the analysis power, the number of samples was
      increased by 25% and n=30 for each group (acupressure group: 30, back massage group: 30, and
      control group: 30). It is planned to collect the data with the Introductory Information Form,
      the Newborn Follow-up Form, the Mother's Follow-up Form, and the Visual Analogue Scale by
      which the Mothers Evaluate Lactation Onset Symptoms. The mothers will be given acupressure 4
      minutes acupressure group, back massage group 3 minutes back massage, and no application will
      be made to the control group, once in the post-op 0th day, 2 times in the post-op 1st day and
      once in the post-op 2nd day. 15 minutes after the applications, the baby will be weighed
      while hungry and will be breastfed under the control of the researcher. Babies will be
      weighed again after breastfeeding. The data of the research will be evaluated using the
      Statistical Package for the Social Sciences 20.0 program. In the evaluation of the data;
      descriptive statistics will be given as percentage, arithmetic mean±standard deviation,
      median and minimum-maximum values, independent two-sample t-test for normally distributed
      variables and Mann-Whitney U test for non-normally distributed variables. Repeated measure
      covariance analysis will be applied to reveal the difference between the milk amounts of the
      mothers between the groups. Statistical significance level will be accepted as p<0.05.
    

Detailed description: 
      Objective: The aim of this study is to examine the effects of acupressure and back massage on
      lactation in cesarean deliveries.

      Hypotheses:

      H01: There is no difference in the amount of breast milk between the acupressure, back
      massage group and the control group in cesarean deliveries.

      H02: There is no difference between the acupressure, back massage group and the control group
      in terms of lactation onset symptoms in cesarean deliveries.

      This study was designed as a randomized controlled experimental study. The study was carried
      out in Kocaeli University Research and Application Hospital and Health Sciences University
      Derince Training and Research Hospital obstetrics service between July 2021 and July 2023.
      planned to be carried out.

      Primiparous mothers who performed cesarean section at Kocaeli University Research and
      Application Hospital and Health Sciences University Derince Training and Research Hospital
      will constitute the research population. The sample size was calculated based on the research
      conducted by Arumsari et al. 2018 to examine the effect of acupressure and relaxation
      exercise combination on breast milk production and breastfeeding self-efficacy. 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. The mean and standard deviation
      values of the breast milk variable in the experimental group were 30.1±16.9 and n=12. In the
      control group, the mean and standard deviation values of the breast milk variable were
      17.6±7.4 and n=12. The effect size was calculated as 0.47 by using the mean, standard
      deviation and sample number values of the related article. 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
      effect size: 0.47, α= 0.05, power: 0.95, and the sample size was at least 72 mothers (n= 24
      for each group). ) was determined. In order to increase the analysis power, the number of
      samples was increased by 25% and n=30 for each group (acupressure group: 30, back massage
      group: 30, and control group: 30). The random number generation program in which group the
      mothers included in the study would be in was determined from the website called "Research
      Team Generator" and divided into three groups. Thus, each mother's group number was
      determined and recorded. Thus, each mother's number and group number would be determined and
      recorded.

      Data Collection Tools Introductory Information Form: This form was prepared by the researcher
      in line with the literature. The form includes 38 questions including socio-demographic,
      obstetric characteristics, information about general health, and characteristics related to
      breast milk and breastfeeding.

      Newborn Follow-up Form: It contains introductory information about the newborn, weight
      follow-up, feeding frequency and number of stools, and bilirubin values. Within the scope of
      the study, blood will not be taken from the newborn, and the existing bilirubin values will
      be used.

      Mother Follow-up Form: This form, prepared by the researcher, contains the estimated amount
      of milk according to the difference in weight of the baby in the morning and evening, the
      average daily sleep duration of the mother and the amount of fluid consumed by the mother.

      The Visual Analog Scale by which the Mothers Evaluate Lactation Onset Symptoms: The Visual
      Analog Scale used in the study of Mauri et al. 2015 will be used in the assessment. Tension,
      temperature increase and pain in the breasts, which are the signs of starting lactation, will
      be scored between 0-10. 0 "None", 1-2 "Too little", 3-4 "A little too much", 5-6 "Too much",
      7-8 "Too much" and 9-10 "Too much, unbearable" and what is the total score? it will be
      understood that the higher the lactation initiation symptoms, the more.

      Pre-Application In order to assess whether the questions have been understood, a preliminary
      study will be conducted with five mothers before starting the study. 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 preliminary study will not be included in the
      sample group.

      Data Collection After obtaining the permissions of the ethics committee and the institution,
      the study can be performed by going to the institutions and performing a cesarean section
      between the first 8-12 hours on the 0th postoperative day. Mothers who are between working
      hours will be welcomed. Mothers who meet the research criteria will be informed about the
      purpose, content and method of the research and those who want to participate in the research
      will be determined.

      To mothers;

        -  1 time on post-op day 0,

        -  Post-op 1st day 2 times,

        -  Acupressure and back massage will be applied 4 times in total, once on the 2nd post-op
           day. No application will be made to the control group.

      If the baby weighing process;

        -  Post-op 2 times on day 0,

        -  Post-op 1st day 4 times,

        -  Post-op will be done 2 times on the 2nd day, 8 times in total. After 15 minutes (min) of
           the applications, the baby will be weighed and breastfed while hungry (before
           breastfeeding). It will be weighed again to measure the average value of the amount of
           breast milk taken immediately after breastfeeding. The scale will have a sensitivity of
           5 grams and will be provided by the researcher.

      Acupressure Application Technique A suitable environment will be prepared for mothers in
      terms of warmth and light, where privacy can be protected. The application points will be
      determined with the acu-point device by choosing the most comfortable position for the
      mother, leaving the application points exposed. The most preferred points ST36 and CV17 were
      selected from the points reported to affect lactation by examining the literature on the
      points to be applied. Acupressure will be applied to CV17 point (single point) and ST36 point
      (bidirectional, right and left) for 2 minutes for a total of 6 minutes. Light pressure will
      be applied with the thumb of the practitioner's hand. Immediately after applying pressure for
      2 minutes for each point, it will be moved to the other point in the symmetrical region and
      the application will be made without interruption. While practicing, the researcher will
      control the time using a digital wrist watch with a stopwatch.

      The assistant researcher received acupressure training on 13.05.2021 and the principal
      researcher also has acupressure training.

      Acupressure Application Points:

      ST 36 point: The Stomach Meridian 36 point is located on the front of the leg and above the
      tibialis anterior muscle. It increases blood flow and plays a role in milk production.

      CV17: Conception Vessel 17 point is located between the nipples, in the midline of the
      sternum, in the 4th intercostal space. This point stimulates blood circulation and stimulates
      milk production.

      Back Massage Application Technique:

      The mother sits in the chair and, leaning forward, puts her arms on the table at her level
      and rests her head on her arms. The mother's breasts are naked and freely released. The
      researcher massages the mother from top to bottom on both sides of the spine between the
      scapula bones. At this time, his fists are clenched and the thumb is open. While pressing
      firmly with his fists, small circular friction movements are made with his thumb. From the
      neck to the scapula, both sides of the spine are rubbed at the same time for 3 minutes. While
      practicing, the researcher will control the time using a digital wrist watch with a
      stopwatch.

      Evaluation of Data The data of the study will be evaluated using the Statistical Package for
      the Social Sciences (SPSS) 22.0 program. All data will first be evaluated with
      Kolmogorov-Smirnov for conformity to normal distribution and then analyzed according to
      fitness for normal distribution. For descriptive statistics, percentages will be used in
      general, arithmetic mean±standard deviation for those that are suitable for normal
      distribution, median and minimum-maximum values for those that are unsuitable. Comparisons
      between groups for numerical variables of sociodemographic and clinical characteristics will
      be made with an independent two-sample t-test for normally distributed variables, and
      Mann-Whitney U test for non-normally distributed variables. Repeated measure covariance
      analysis will be applied to reveal the difference between the milk amounts of the mothers
      between the groups. Statistical significance level will be accepted as p<0.05.
    

Intervention name(s): acupressure group; back massage group; control group
Intervention type(s): Other; Other; Other
Intervention description(s): A suitable environment will be prepared for mothers in terms of warmth and light, where privacy can be protected. The application points will be determined with the acu-point device by choosing the most comfortable position of the mother, leaving the application points exposed. The most preferred points ST36 and CV17 were selected from the points reported to affect lactation by reviewing the literature on the points to be compressed. Acupressure will be applied to CV17 point (single point) and ST36 point (bidirectional, right and left) for 2 minutes for a total of 6 minutes. Light pressure will be applied with the thumb of the practitioner's hand. Immediately after applying pressure for 2 minutes for each point, it will be moved to the other point in the symmetrical region and the application will be made without interruption. While practicing, the researcher will control the time using a digital wrist watch with a stopwatch.; The mother sits in the chair and leans forward, placing her arms on the table at her level and resting her head on her arms. The mother's breasts are naked and freely released. The researcher massages the mother from top to bottom on both sides of the spine between the scapula bones. At this time, his fists are clenched and the thumb is open. While pressing firmly with his fists, small circular friction movements are made with his thumb. From the neck to the scapula, both sides of the spine are rubbed at the same time for 3 minutes. While practicing, the researcher will control the time using a digital wrist watch with a stopwatch.; No application will be made to the mothers in this group, and the amount of milk will be measured by weighing the baby before and after breastfeeding.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: lactation; cesarean delivery; acupressure; back massage