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临床试验/NCT07304037
NCT07304037
Enrolling By Invitation
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The Effect of Skin-to-Skin Contact Applied in the Early Postpartum Period on Maternal Pain, Birth Satisfaction, and Maternal Vital Signs Dynamics

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2025年5月12日最近更新:

概览

阶段
不适用
状态
Enrolling By Invitation
发起方
Istanbul University - Cerrahpasa
入组人数
68
试验地点
1
主要终点
Visuel Analog Scale -Pain

概览

简要总结

Skin-to-skin contact (STSC) initiated within the first hour after birth is a fundamental practice that supports both the mother's and the newborn's physiological and psychological adaptation (Çelik & Kök, 2022). The World Health Organization recommends at least 90 minutes of uninterrupted SKC immediately after birth and defines this practice as a mandatory component of care under the Baby-Friendly Hospital Initiative (World Health Organization, 2024; Abdulghani et al., 2018; Sharma, 2016). The positive effects of TTT on maintaining the newborn's temperature, glucose regulation, physiological stability, and mother-infant bonding have been proven (Sezici & Yiğit, 2020; Safar et al., 2018). In addition, it has been reported that it can shorten the third stage of labor by increasing maternal oxytocin release and reduce maternal stress and anxiety (Püsküllüoğlu et al., 2022; Harati Kabir et al., 2024).

In the study, mothers in the intervention group will receive one hour of uninterrupted TTT immediately after delivery; routine midwifery care will continue in the control group. In both groups, maternal pain levels, birth satisfaction, and vital signs (body temperature, oxygen saturation, heart rate, and blood pressure) will be assessed immediately after delivery, and at 30, 60, and 90 minutes.

The sample size was calculated using GPower, and a total of 68 participants (34 in each group) will be included in the study. Inclusion criteria include women aged 18 years or older who have had a full-term vaginal delivery and have a single, uncomplicated pregnancy. The data collection tools used will be the Demographic Information Form and the Visual Analog Scale (VAS).

The findings of the study are expected to enhance the quality of midwifery care by supporting the integration of TTT into clinical practice in early postpartum care.

详细描述

H1: There is a difference in pain scores measured using the Visual Analog Scale (VAS) between the group that received uninterrupted skin-to-skin contact for one hour after birth and the control group immediately after birth, at 30, 60, and 90 minutes.

H1: There is a difference in birth satisfaction scores measured using the Visual Analog Scale (VAS) between the group that received uninterrupted skin-to-skin contact for one hour after birth and the control group immediately after birth, at 30, 60, and 90 minutes.

H1: There is a difference between the group that received uninterrupted skin-to-skin contact for one hour after birth and the control group in terms of maternal body temperature, oxygen saturation, heart rate, and blood pressure measurements taken immediately after birth and at 30, 60, and 90 minutes.

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
Triple (Participant, Care Provider, Outcomes Assessor)

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

  • Voluntarily agree to participate in the study
  • Be able to read, understand, and write in Turkish
  • Be 18 years of age or older
  • Have given birth vaginally
  • Have given birth to a single baby
  • Be at term (between 38-42 weeks of gestation)
  • Have given birth vaginally in vertex presentation
  • Estimated fetal weight between 2500-4000 grams
  • Not having received any analgesia or anesthesia to relieve pain and fatigue during labor
  • Having a pregnancy without maternal or fetal complications

排除标准

  • Multiple pregnancies
  • High-risk pregnancies with complications

结局指标

主要结局

Visuel Analog Scale -Pain

时间窗: At 30, 60, and 90 minutes after birth

Min: 0- Max:10

Visuel Analog Scale- Birth satisfaction

时间窗: At 30, 60, and 90 minutes after birth

Min:0-Max:10

次要结局

未报告次要终点

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasemin Dincel

Researcher Assistant

Istanbul University - Cerrahpasa

研究点 (1)

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