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临床试验/NCT05903846
NCT05903846已完成不适用

The Effect of Oketani Massage on Breastfeeding Success and Breast Engorgement in Mothers Delivering by Cesarean Section: A Randomized Controlled Study

Agri Ibrahim Cecen University1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2022年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
116
试验地点
1
主要终点
LATCH breastfeeding diagnostic scale

研究概览

简要总结

The aim of this study was to examine the effect of octani massage on breastfeeding success and breast engorgement in mothers who gave birth by cesarean section. The research was carried out in the gynecology service of Ağrı Training and Research Hospital between November 2022 and April 2023. The universe of the study consisted of mothers who were hospitalized in the gynecology service of Ağrı Training and Research Hospital between November 2022 and April 2023 and gave birth by cesarean section. The Open Epi calculation tool was used to determine the sample of the study. The sample calculation was made on the average score differences in the Open Epi info program. Accordingly, it was planned to include 106 mothers, 53 of whom were in the control group and 53 in the massage group. Considering the sample loss to be experienced during data collection, a total of 116 mothers, 58 in the control group and 58 in the massage group, were included in the study. Randomization of the groups participating in the study was made as simple randomization using the www.random.org site. Introductory Characteristics Questionnaire, oketany massage follow-up form, breast engorgement assessment scale and LATCH breastfeeding diagnostic measurement tool were used to collect the research data.

详细描述

The research was carried out in two groups, namely the octopus massage group and the control group.

Oketani Massage Group: According to the Ministry of Health, the follow-up period for mothers after cesarean section in Turkey is 48 hours. After the mothers in the massage group were taken to the service, oketani massage was applied three times a day for an average of 15-20 minutes, starting before breastfeeding. Massage was applied to the Oketani massage group by a midwife working in the clinic. Before the mothers were discharged, the breast engorgement and breastfeeding status of the mothers were evaluated using the breast fullness assessment scale and the LATCH breastfeeding diagnostic scale. Control Group: No intervention was made in the control group and routine follow-up of mothers and babies will be performed after cesarean section. No intervention was made regarding the breastfeeding process of the mothers, other than the breastfeeding counseling given by the breastfeeding consultant according to the hospital protocol. Before the mothers were discharged, the breast engorgement a and breastfeeding status of the mothers were evaluated using the breast fullness assessment scale and the LATCH breastfeeding diagnostic 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 (Outcomes Assessor)

盲法说明

Massage was applied to the Oketani massage group by a midwife working in the clinicThe outcome assessor does not know who the groups are.

入排标准

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

入选标准

  • for the study:
  • Delivery by cesarean section
  • Single and live birth,
  • 38-40 Giving birth between weeks
  • Not having a mental or physical disability that prevents breastfeeding,
  • The baby does not need neonatal intensive care
  • The baby does not have a condition that prevents breastfeeding
  • Sharing the same room with the baby
  • Agreeing to participate in the research

排除标准

  • from the study:
  • Refusal to participate in the study
  • Giving birth normally
  • Giving birth prematurely
  • Having a mental and physical disability that prevents breastfeeding
  • Being 18 years of age or younger
  • Transferring the baby to the neonatal intensive care unit
  • Having a condition that prevents breastfeeding

研究组 & 干预措施

Oketani massage group

Experimental

According to the Ministry of Health, the follow-up period for mothers after cesarean section in Turkey is 48 hours. After the mothers in the massage group were taken to the service, oketani massage was applied three times a day for an average of 15-20 minutes, starting before breastfeeding. Massage was applied to the Oketani massage group by a midwife working in the clinic. Before the mothers were discharged, the breast fullness and breastfeeding status of the mothers were evaluated using the breast engorgement assessment scale and the LATCH breastfeeding diagnostic scale.

干预措施: Oketani massage (Other)

Control group

No Intervention

No intervention was made in the control group and routine follow-up of mothers and babies will be performed after cesarean section. No intervention was made regarding the breastfeeding process of the mothers, other than the breastfeeding counseling given by the breastfeeding consultant according to the hospital protocol. Before the mothers were discharged, the breast fullness and breastfeeding status of the mothers were evaluated using the breast fengorgement assessment scale and the LATCH breastfeeding diagnostic scale.

结局指标

主要结局

LATCH breastfeeding diagnostic scale

时间窗: postpartum 48 hours from birth

by observing breastfeeding; It is an assessment tool that is quick and easy to apply, created to detect problems that may occur during breastfeeding. Scoring is done between 0-2 and the maximum score that can be obtained is 10. In the non-breakpoint measurement tool, a high score indicates successful breastfeeding.

Breast engorgement assessment scale

时间窗: postpartum 48 hours from birth

The scale is scored from 1 to 6. On the scale, "1" is evaluated as no soft change, while "6" is expressed as very hard and very sensitive. If the score from the scale is higher than 4, it means that there is breast fullness.

次要结局

未报告次要终点

研究者

发起方
Agri Ibrahim Cecen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emine Serap ÇAĞAN

assistant professor

Agri Ibrahim Cecen University

研究点 (1)

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