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临床试验/NCT04883866
NCT04883866Unknown不适用

Impact of Telephone Breastfeeding Support on Breastfeeding Outcomes for Mothers With Premature Babies: Randomized Controlled Study

Akdeniz University2 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
62
试验地点
2
主要终点
Breastfeeding Self-Efficacy Scale (short form)

研究概览

简要总结

It was observed that premature babies had the risk of insufficient milk intake and a lower rate of breastfeeding compared to term babies. Various problems may occur at home, especially after breastfeeding training in the hospital. After discharge, support and counseling should be provided to eliminate problems that may stop breastfeeding or to prevent events that may prevent breastfeeding. The aim of this study is to examine the effect of "Telephone Breastfeeding Support" given to mothers of premature babies discharged from the neonatal intensive care unit on breastfeeding results.

详细描述

The study was planned as a randomized, parallel two-group, controlled experimental design. This research will be conducted between June 2021 and June 2022 with premature baby mothers. The sample of the study will be mothers (n = 62) of premature babies discharged from Antalya Training and Research Hospital Neonatal Intensive Care Unit. The discharge routine procedures of all mothers participating in the study will be completed and a breastfeeding guide prepared for premature babies will be sent to the phone. On the 3rd day after discharge, a reminder message will be sent to support the mother in the intervention group (n = 31) and to encourage breast milk. Throughout the program, 21 messages will be sent to the mothers in the first month after discharge, via the messaging application (whatsapp, bip, telegram, etc.) In addition, seven phone calls will be made once a week in the first month after discharge, and once a month in the eighth, twelfth and sixteenth weeks. Data will be collected by Mother-Baby Introductory Information Form, Breastfeeding Self-Efficacy Scale (short form) (BSES), Infant Feeding Attitude Scale (IIFAS) and Breastfeeding Time Assessment Form. The pre-test will be taken with the Mother-Baby Descriptive Information Form, BSES and IIFAS during the discharge routine procedures, and the post-test will be taken with the BSES, IIFAS and Breastfeeding Time Assessment Form when the baby is six months old. Ethics Committee and Institutional Permission was obtained for the study. In addition, written consent will be obtained from the participants. Statistical analysis will be done using SPSS 23.0 and significance will be evaluated at p <0.05. Support will be received in the analysis phase of the Statistical Information Unit of Akdeniz University. It is anticipated that new information from research data will improve breastfeeding results of premature babies and guide new research.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

At the time of discharge, the participants will not know that they are in the intervention and control group. Participants will be blinded. In the evaluation of the data, the groups will not be coded as intervention and control groups, they will be coded as group A and group B, and their analysis will be evaluated and reported by an independent statistician. In addition, the statistician will be blind.

入排标准

性别
Female
接受健康志愿者

入选标准

  • Whose baby was born between 34 weeks + 0 days and 36 weeks + 6 days (late preterms),
  • Does not have severe congenital anomalies in her baby (according to hospital records),
  • Breastfeeding her baby,
  • Reading and writing,
  • Can speak and understand Turkish,
  • Mothers who agreed to participate in the study,
  • Mothers having a smartphone.

排除标准

  • Mothers with previous experience of breastfeeding a premature baby,
  • Plural baby,
  • Mother's breastfeeding disability (according to hospital records).

结局指标

主要结局

Breastfeeding Self-Efficacy Scale (short form)

时间窗: 0-6 months (During discharge routine procedures and when the baby is six months old)

The scale, which is valid and reliable in our country by Aluş Tokat, Okun and Dennis (2010), consists of 14 items and is a Likert type scale rated between 1 and 5. The minimum score that can be retrieved from the scale is 14 and the maximum is 70. As the score rises, high breastfeeding is an indicator of self-sufficiency.

Infant Feeding Attitude Scale

时间窗: 0-6 months (During discharge routine procedures and when the baby is six months old)

The scale was developed to evaluate women's attitudes towards breastfeeding and to predict breastfeeding duration as well as the choice of baby feeding method. The scale consists of 5-point Likert type and 17 items. The total attitude score ranges from 17 (showing a positive attitude to bottle feeding) to 85 (reflecting a positive attitude towards breastfeeding). The higher the score on the scale, the higher it indicates the higher breastfeeding attitude.

3. Breastfeeding Time Evaluation Form Breastfeeding Time Evaluation Form Breastfeeding Time Evaluation Form

时间窗: When the baby is six months old

Prepared by researcher to find out breastfeeding status when babies are 6 months old.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ezgi Boz

Principal Investigator

Akdeniz University

研究点 (2)

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