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Breast Milk CollectionNCT05420389

Breast Massage and Hot Compress Application to Mothers With Premature Babies at Newborn Intensive Care University Effect on Milk Release and Anxiety

A study testing breast massage, hot compress and breast massage-hot compress in people with Breast Milk Collection and Breast Pumping, run by Seyma Ertugral 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
Search all trials

Trial summary

This research was carried out in order to determine the effect of breast massage and hot compresses on milk release and anxiety to mothers with premature babies in YYBU (Neonatal Intensive Care Unit) Read more about this study

Who is it for?
Ages 18 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
breast massage, hot compress and breast massage-hot compress
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2020to 1 Mar 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 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Who has agreed to participate in the research,
  • Without communication barriers, She gave birth by C-section.
  • Preterm infant mothers who give birth before the 37th gestational week,
  • With a birth weight of less than 2000 grams,
  • Severely chronic disease, pregnancy complications or non-previous breast surgery,
  • Preterm infant mothers treated in YYBU will be included in the study.

Who cannot join

  • Failure to meet the inclusion criteria is the exclusion criteria.
  • Failure to complete the data collection forms,
  • the participant's desire to leave at any time of the study,
  • the single-option information in the data collection forms,
  • the failure to communicate with the mother after discharge in the collection of the work data.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Etlik Zübeyde Hanım Kadın Hastalıkları Ve Doğum Hastanesi

    Ankara, Etlik, 06010

Other trials in Turkey (Türkiye)

About this study

Official title: Breast Massage and Hot Compress Application to Mothers With Premature Babies at Newborn Intensive Care University Effect on Milk Release and Anxiety: Randomized Controlled Study

This research was carried out in order to determine the effect of breast massage and hot compresses on milk release and anxiety to mothers with premature babies in YYBU (Neonatal Intensive Care Unit)

Read the detailed description

Participants who met the criteria for inclusion of the study were informed about the purpose of the research, the scales used, the data to be collected and the purposes of use of this data. Participants who agreed to participate voluntarily in the study were given a questionnaire form in an environment where they could respond without distraction in their clinic and responded under the supervision of the researcher. The answer to the questionnaire was completed in approximately 10-15 minutes. Suitable for the research group in which participants are included; control group, breast massage application group, hot compress group to the breast, massage to the breast and data collection form suitable for hot compress group.Participants were followed by the post op 48 hour researcher. A mother with 120 premature babies who met the criteria for inclusion in the study was taken. The applications carried out in the study were shown to the mother by the researcher in a hands-on manner, explained and given a brochure explaining the application. The mothers who were included in the control group were informed about the use of milking pumps in the routine application of the hospital, the data collection form and the condition anxiety scale were filled out on the first day. These mothers were told by the researcher how to fill out the breast milk follow-up form for 4 days as long as they were in the hospital. Milk amounts are measured in ml. On the last day, the situation anxiety scale has been filled.

The mothers who were included in the breast massage group were informed about the use of milking pumps in the routine application of the hospital, the data collection form and the condition anxiety scale were filled out on the first day. These mothers were shown breast massage during the use of milking pumps, they were provided with a brochure explaining the application. As long as the breast milk follow-up form to record the amounts of milk they milked was in the hospital, the researcher explained how to fill it out when discharged and was asked to fill out the last-day conditional anxiety scale (SATI-I). Milk amounts are measured in ml.

Mothers who were included in the hot application group were informed about the use of milking pumps in the routine application of the hospital and the condition anxiety scale (STAI-I) was filled out on the first day. These mothers were shown the hot application they would make during the use of milking pumps, they were provided with the application and a brochure was given explaining the application.

The hot chest compress to be used in this group will be used in the Lansinoh brand Thera°Pearl® Hot Breast Therapy pad, which is sold in medical medicines in pharmacies approved by the Ministry of Health.

The breast milk follow-up form, in which they will record the amounts of milk they milk, was explained by the researcher in the hospital and how to fill it out when they were discharged, and they were asked to fill out a last-day anxiety scale. Mothers who were included in the breast massage and hot application group were informed about the use of milking pumps in the routine application of the hospital, the data collection form and the condition anxiety scale were filled out on the first day. These mothers were shown breast massage and hot application during the use of milking pumps, they were provided with their own application and a brochure was given explaining the application. The breast milk follow-up form, in which they will record the amounts of milk they milk, was explained by the researcher in the hospital and how to fill it out when they were discharged, and they were asked to fill out a last-day anxiety scale.

In the study, a MANDELA type milking pump was used, which belongs to the hospital where the work was carried out to milk the mothers. The milking pump setting of the mothers who participated in the study was also adjusted to moderate level.

Where the research was carried out : The research was carried out in the cesarean clinic of Ankara Etlik Zubeyde Women's Obstetrics and Gynecology Education and Research Hospital.

Universe and Sampling of The Research: The universe of this research is made up of patients who meet the criteria for inclusion in the cesarean clinic at Ankara Etlik Zubeyde Women's Obstetrics and Gynecology Education and Research Hospital and who agree to participate in the research. The sample size required for the research question created to examine the reduction of anxiety by increasing the amount of milk of the mother of breast massage, hot compress, breast massage-hot compress application to premature baby was examined in groups of thirtysomethings. Accordingly, the sample size of 120 people was grouped as Massage group [n=30], Hot group [n=30], Massage and Hot group [n=30] and Control group[n=30] as individuals. Randomization of groups was carried out through the computer randomization program Random Allocation Software program.

Data Evaluation: The analysis was conducted through the IBM SPSS Statistics 23 package program. When evaluating the study data, frequency (number, percentage) for categorical variables and descriptive statistics (mean, standard deviation, median, minimum, maximum) are given for numerical variables. The assumptions of normality of numerical variables by groups were examined by shapiro wilk normality test and it was observed that some variables were not distributed normally. Therefore, both parametric and non-parametric statistical methods were used in the study.The relationships between the two Independent categorical variables are interpreted by The Square analysis. Fisher Exact test results were used in cases where the expected value assumption was not provided in the Square analysis. The differences between more than two independent groups were looked at with the Kruskal Wallis test for variables that showed normal distribution, one-way variance analysis (ANOVA) for variables that did not have normal distribution. The differences between the Dependent Sample T Test and more than two dependent numeric variables for variables with normal distribution between two dependent numeric variables were examined with Friedman's Analysis.The power of the work is calculated by the GPower package program. In the study, the effect width was found to be 0.62 and the strength of the study, which was completed with a total of 120 people including 30 massages, 30 hot applications, 30 massages and hot treatments and 30 controls, was found to be 80.1% at the 0.05 significant level. Statistical signation was interpreted as 0.05 in the analysis.

Data Collection Tools:The research data were collected using the Data Collection Form, Spielberger's Situational Anxiety Inventory and Breast Milk Follow-up Form, which includes questions and sociodemographic data determined by the researchers in accordance with the subject of the research in line with the literature information.

Being tested
breast massage, hot compress, breast massage-hot compress
Keywords
Breast Milk, Premature, Milking Pump, Hot Compress, Breast Massage, Anxiety, randomized controlled study
Medical subject headings
Breast Milk Expression, Premature Birth, Anxiety Disorders

What participants receive

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

  • breast massageOther

    Mothers who were included in the breast massage group who met the research criteria were informed about the use of milking pumps in the routine application of the hospital and the condition anxiety scale was filled out on the first day. These mothers were shown breast massage during the use of milking pumps, they were provided with their own application and a brochure was given explaining the application.As long as the breast milk follow-up form to record the amounts of milk they milked was in the hospital, the researcher explained how to fill it out when discharged and was asked to fill out the last-day conditional anxiety scale (SATI-I). Milk amounts are measured in ml.

  • hot compressOther

    Mothers who were included in the hot application group were informed about the use of milking pumps in the routine application of the hospital and the condition anxiety scale (STAI-I) was filled out on the first day. These mothers were shown the hot application they would make during the use of milking pumps, they were provided with the application and a brochure was given explaining the application.The hot chest compress to be used in this group will be used in the Lansinoh brand Thera°Pearl® Hot Breast Therapy pad, which is sold in medical medicines in pharmacies approved by the Ministry of Health.The breast milk follow-up form, in which they will record the amounts of milk they milk, was explained by the researcher in the hospital and how to fill it out when they were discharged, and they were asked to fill out a last-day anxiety scale.

  • breast massage-hot compressOther

    Mothers who were included in the breast massage and hot application group were informed about the use of milking pumps in the routine application of the hospital, the data collection form and the condition anxiety scale were filled out on the first day. These mothers were shown breast massage and hot application during the use of milking pumps, they were provided with their own application and a brochure was given explaining the application.As long as the breast milk follow-up form to record the amounts of milk they milked was in the hospital, the researcher explained how to fill it out when discharged and was asked to fill out the last-day conditional anxiety scale (SATI-I). Milk amounts are measured in ml.

Study groups in NCT05420389
Study groupRoleWhat they receive
breast massageExperimentalThe mothers who were included in the breast massage group were informed about the use of milking pumps in the routine application of the hospital, the data collection form and the state anxiety scale were filled out on the first day. These mothers were shown breast massage during the use of milking pumps, they were provided with their own application and a brochure was given explaining the application.As long as the breast milk follow-up form to record the amounts of milk they milked was in the hospital, the researcher explained how to fill it out when discharged and was asked to fill out the last-day state anxiety scale (SATI-I). Milk amounts are measured in ml.
Receives: Other: breast massage
hot compressExperimentalMothers who were included in the hot application group were informed about the use of milking pumps in the routine application of the hospital and the state anxiety scale (STAI-I) was filled out on the first day. These mothers were shown the hot application they would make during the use of milking pumps, they were provided with the application and a brochure was given explaining the application.The hot chest compress to be used in this group will be used in the Lansinoh brand Thera°Pearl® Hot Breast Therapy pad, which is sold in medical medicines in pharmacies approved by the Ministry of Health.The breast milk follow-up form, in which they will record the amounts of milk they milk, was explained by the researcher in the hospital and how to fill it out when they were discharged, and they were asked to fill out a last-day anxiety scale.
Receives: Other: hot compress
breast massage-hot compressExperimentalMothers who were included in the breast massage and hot application group were informed about the use of milking pumps in the routine application of the hospital, the data collection form and the state anxiety scale were filled out on the first day. These mothers were shown breast massage and hot application during the use of milking pumps, they were provided with their own application and a brochure was given explaining the application.The breast milk follow-up form, in which they will record the amounts of milk they milk, was explained by the researcher in the hospital and how to fill it out when they were discharged, and they were asked to fill out a last-day anxiety scale.
Receives: Other: breast massage-hot compress
control groupNo interventionThe mothers who were included in the control group were informed about the use of milking pumps in the routine application of the hospital, the data collection form and the state anxiety scale were filled out on the first day. These mothers were told by the researcher how to fill out the breast milk follow-up form for 4 days as long as they were in the hospital. Milk amounts are measured in ml. On the last day, the state anxiety scale has been filled.

What is being measured

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

  1. Amount of Milk

    Milk quantities measured in ml.

    Measured: Change from Amount of Milk 4 Days

  2. Level of Anxiety

    The state anxiety scale, the responses are classified as (1) Not at all, (2) A little, (3) A lot, and (4) Completely; Responses in the trait anxiety scale are classified as (1) almost never, (2) sometimes, (3) often, and (4) almost always. There are two kinds of statements (direct and reversed) in scales. While scoring these statements, those with a score of 1 turn into 4, and those with a score of 4 turn into 1. In direct statements, responses with a value of 4 indicate high anxiety. In reversed statements, responses with a value of 1 indicate high anxiety while those with a value of 4 indicate low anxiety. The scores obtained from both scales range from 20 to 80. The score obtained from the scales constitutes the individual's score to be interpreted at the level of anxiety. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    Measured: 1th day

  3. Level of Anxiety

    The state anxiety scale, the responses are classified as (1) Not at all, (2) A little, (3) A lot, and (4) Completely; Responses in the trait anxiety scale are classified as (1) almost never, (2) sometimes, (3) often, and (4) almost always. There are two kinds of statements (direct and reversed) in scales. While scoring these statements, those with a score of 1 turn into 4, and those with a score of 4 turn into 1. In direct statements, responses with a value of 4 indicate high anxiety. In reversed statements, responses with a value of 1 indicate high anxiety while those with a value of 4 indicate low anxiety. The scores obtained from both scales range from 20 to 80. The score obtained from the scales constitutes the individual's score to be interpreted at the level of anxiety. A high score indicates a high level of anxiety, and a low score indicates a low level of anxiety.

    Measured: 4th day

  4. Satisfaction Rating

    Massage is a scale from 1 to 10 to determine the satisfaction of mothers from hot compresses, hot-massage compress applications. High score indicates satisfaction, low score indicates dissatisfaction

    Measured: 4th day

Timeline

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

  1. First posted15 Jun 2022
  2. Study start1 Jan 2020
  3. Primary completion1 Nov 2020
  4. Study completion1 Mar 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
Model description
There will be 4 groups.three interventional and one control group.
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05420389
Sponsor's protocol ID
gülhane sbu
Status last verified
Jun 2022
First submitted
23 Apr 2022
Last updated
21 Jun 2022
Results posted
No
Data monitoring committee
No
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 breast massage, hot compress and breast massage-hot compress in people with Breast Milk Collection and Breast Pumping, run by Seyma Ertugral 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 6 inclusion and 5 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 21 Jun 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 Milk (time frame: Change from Amount of Milk 4 Days). The study lists 4 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 21 Jun 2022.

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