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LactationNCT05123183

Nonpharmacological Methods and Lactation

A study testing acupressure group and back massage group in people with Lactation, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Lactation
What is being tested?
acupressure group and back massage group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 May 2021to 30 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.),
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  • 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.

Who cannot join

  • • 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,
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  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Aydın Adnan Menderes University

    Efeler, Aydın, 09010

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Acupressure and Back Massage on Lactation in Cesarean Deliveries: A Randomized Controlled Trial

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.

Read the 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.

Conditions
Lactation
Being tested
acupressure group, back massage group, control group
Keywords
lactation, cesarean delivery, acupressure, back massage
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • acupressure groupOther

    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.

  • back massage groupOther

    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.

  • control groupOther

    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.

Study groups in NCT05123183
Study groupRoleWhat they receive
Acupressure groupActive comparatorAcupressure will be applied to ST36 and CV17 points.
Receives: Other: acupressure group
Back MassageActive comparatorBack massage will be applied.
Receives: Other: back massage group
Control GroupActive comparatorNo 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.
Receives: Other: control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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

    Measured: 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.

  6. 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

    Measured: 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.

  7. 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2021
  2. Study start15 May 2021
  3. Primary completion18 Jan 2022
  4. Study completion30 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05123183
Sponsor's protocol ID
Resmiye-01
Status last verified
Feb 2022
First submitted
23 Oct 2021
Last updated
16 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing acupressure group and back massage group in people with Lactation, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

amount of breast milk (time frame: The baby will be weighed 8-12 hours after the cesarean section.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2022.

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