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临床试验/NCT05420389
NCT05420389已完成不适用

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

Seyma Ertugral2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Amount of Milk

研究概览

简要总结

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)

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • Failure to meet the inclusion criteria is the exclusion criteria.
  • Exclusion (Withdrawal) from the Study 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.

结局指标

主要结局

Amount of Milk

时间窗: Change from Amount of Milk 4 Days

Milk quantities measured in ml.

Satisfaction Rating

时间窗: 4th day

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

Level of Anxiety

时间窗: 4th day

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.

次要结局

未报告次要终点

研究者

发起方
Seyma Ertugral
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Seyma Ertugral

Principal Investigator

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

研究点 (2)

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