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

NCT05420389 | Completed

• 1 other identifier: gülhane sbu
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Breast Milk Collection; Breast Pumping; Massage Therapy

Keywords

Breast Milk; Premature; Milking Pump; Hot Compress; Breast Massage; Anxiety; randomized controlled study

Outcome Measures

Primary Outcomes (4)

• Amount of Milk

  Milk quantities measured in ml.

  Change from Amount of Milk 4 Days

• 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.

  1th day

• 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.

  4th day

• 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

  4th day

Study Arms (4)

breast massage

EXPERIMENTAL

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 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.

Other: breast massage

hot compress

EXPERIMENTAL

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 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.

Other: hot compress

breast massage-hot compress

EXPERIMENTAL

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 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.

Other: breast massage-hot compress

control group

NO INTERVENTION

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 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.

Interventions

breast massage OTHER

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.

breast massage

hot compress OTHER

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.

hot compress

breast massage-hot compress OTHER

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.

breast massage-hot compress

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: 18 Years to 45 Years (Adult)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seyma Ertugral: lead

Study Sites (1)

Etlik Zübeyde Hanım Kadın Hastalıkları Ve Doğum Hastanesi

Ankara, Etlik, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Milk Expression; Premature Birth; Anxiety Disorders

Condition Hierarchy (Ancestors)

Breast Feeding; Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The volunteer who is in the latent phase of labor will not know which group she will be in before joining the study. After accepting to participate in the study, the volunteer will be informed about which group she will be in.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There will be 4 groups.three interventional and one control group.

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: June 15, 2022
• Study Start: January 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: March 1, 2022
• Last Updated: June 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)