Nonpharmacological Methods and Lactation

NCT05123183 | Completed DMC

• 1 other identifier: Resmiye-01
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lactation

Keywords

lactation; cesarean delivery; acupressure; back massage

Outcome Measures

Primary Outcomes (7)

• amount of breast milk

  The baby will be weighed before and after breastfeeding. The amount of milk will be calculated according to the difference in weight.

  The baby will be weighed 8-12 hours after the cesarean section.

• amount of breast milk

  The baby will be weighed before and after breastfeeding. The amount of milk will be calculated according to the difference in weight.

  Reported the use of baby weighing in postoperative period on 1.days at 8.00-12:00 am.

• amount of breast milk

  The baby will be weighed before and after breastfeeding. The amount of milk will be calculated according to the difference in weight.

  Reported the use of baby weighing in postoperative period on 1.days at 16.00-20:00 pm.

• amount of breast milk

  The baby will be weighed before and after breastfeeding. The amount of milk will be calculated according to the difference in weight.

  Reported the use of baby weighing in postoperative period on 2.days at 08.00-16:00 am.

• Visual Analogue Scale by which Mothers Evaluate Lactation Onset Signs

  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 onset symptoms, the more

  The Visual Analogue Scale, in which the Mothers Evaluate Lactation Onset Symptoms, will be filled in by the mothers between 8-12 hours of the cesarean section.

• Visual Analogue Scale by which Mothers Evaluate Lactation Onset Signs

  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 onset symptoms, the more

  The Visual Analogue Scale, in which the Mothers Evaluate Lactation Onset Symptoms, will be filled in by the mothers between in postoperative period on 1.days at 16.00-20:00 pm.

• Visual Analogue Scale by which Mothers Evaluate Lactation Onset Signs

  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 onset symptoms, the more

  The Visual Analogue Scale, in which the Mothers Evaluate Lactation Onset Symptoms, will be filled in by the mothers between in postoperative period on 2.days at 08.00-16:00 am

Study Arms (3)

Acupressure group

ACTIVE COMPARATOR

Acupressure will be applied to ST36 and CV17 points.

Other: acupressure group

Back Massage

ACTIVE COMPARATOR

Back massage will be applied.

Other: back massage group

Control Group

ACTIVE COMPARATOR

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.

Other: control group

Interventions

acupressure group OTHER

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.

Acupressure group

back massage group OTHER

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.

Back Massage

control group OTHER

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Between the ages of 18-35,
• Birth after 37 weeks of gestation,
• Caesarean section with regional anesthesia,
• Primiparous,
• No contraindications for breastfeeding (infection, contraindicated drug use, breast problems, etc.),
• Having no health problems (tuberculosis, HIV, cancer, etc.),
• Not using drugs to increase breast milk, vitamins and additional supplements,
• Does not have any problems preventing communication,
• At least primary school graduate,
• Able to speak and understand Turkish,
• Volunteer mothers who agree to participate in the study will be included.

You may not qualify if:

• The baby has contraindications for breastfeeding (galactosemia, congenital anomalies, etc.),
• Having postpartum complications (bleeding, embolism, etc.),
• Separated from her baby for any reason after birth (in cases where the mother or baby is referred, hospitalized in intensive care or isolated),
• Having complications during pregnancy (gestational diabetes, preeclampsia, Rh incompatibility, heart disease, etc.),
• Tissue integrity deteriorated in the area to be treated,
• Having lost her baby,
• Smoking or using alcohol,
• Those who test positive for Covid-19 will be excluded from the study.
• Those who want to leave the research at any stage of the research will be excluded from the research.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University

Efeler, Aydın, 09010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ayten Taşpınar, Prof. Dr.

  aytaspinar@yahoo.com

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: research assistant

Study Record Dates

• First Submitted: October 23, 2021
• First Posted: November 17, 2021
• Study Start: May 15, 2021
• Primary Completion: January 18, 2022
• Study Completion: January 30, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)