The Effect of Skin-to-Skin Contact After Elective Cesarean Section on Pain and Stress Levels of the First Intramuscular Injection of the Newborn
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- ALPS-Neo Neonatal Pain and Stress Rating Scale
研究概览
简要总结
This study is carried out to examine the effect of skin-to-skin contact on the pain and stress level of the first intramuscular injection after elective cesarean section. The universe of the research will be women who have had elective cesarean section at Darıca Farabi Training and Research Hospital. The sample size of the study was calculated using the G*Power 3.1.9.2 program. The minimum number of individuals to be included in the sample of this study was calculated by taking G*Power 3.1.9.2, effect size: 1.42 α= 0.05, power: 0.95, and the sample size was determined as at least 14 mothers and their newborns in each group (skin skin-to-skin contact group: 14, non-skin-to-skin contact group: 14). In the study, possible data losses will be foreseen and 60 newborns and mothers, 30 of which will be in the intervention group and 30 in the control group, will be taken. The group of the participants included in the research will be divided into two groups by determining the random number generation program on the website called "Random List". (https://www.randomlists.com/). After obtaining the necessary ethics committee and institutional permissions for the implementation of the study, participants who had a cesarean delivery and who met the inclusion criteria of the study will be interviewed by going to the institution. Those who accept and want to participate in the research will have the Voluntary Consent Form read and their signatures will be taken. Term newborns meeting the criteria will be divided into intervention and control groups. The data will be collected by the researcher working in the delivery room of the hospital through face-to-face interviews. In the study, newborns who received skin-to-skin contact during the first IM injection will be included in the intervention group, and newborns who have been routinely injected intramuscularly in the delivery room will be included in the control group. In the study, all the steps of the intervention and control group newborns before and after the application will be carried out by the researcher.
详细描述
Aim: This study will be carried out to examine the effect of skin-to-skin contact after elective cesarean section on the pain and stress level of the first intramuscular injection given to the newborn.
Research hypothesis:
Hypothesis (H0): Skin-to-skin contact has no effect on the level of pain and stress felt during the first intramuscular injection in newborns after elective cesarean section.
Hypothesis (H1): Skin-to-skin contact has an effect on the level of pain and stress felt during the first intramuscular injection in newborns after elective cesarean section.
Type of Study: This study was designed as a randomized controlled experimental study.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able to speak and understand Turkish,
- •Conceiving naturally,
- •At the end of the gestational week (37-42 weeks),
- •Will have an elective cesarean delivery,
- •In cesarean delivery, only spinal anesthesia is applied,
- •No hearing problem,
- •Women willing to participate in the research,
- •Not having a risky pregnancy,
- •Single fetus,
- •A first-minute APGAR score (scoring system that shows the newborn's health status) is 7 and above (healthy newborn that does not require any intervention),
- •No congenital anomaly,
- •Does not require observation in neonatal intensive care,
- •Newborns with a birth weight between 2500 - 4000 g.
排除标准
- •Those who do not have sufficient mental health to fill out the questionnaire,
- •Newborns who need oxygen support or dead newborns
- •Exposed to any painful stimulus (Venous-capillary sample),
- •Those who may refuse to receive the hepatitis B vaccine, vitamin K or any injections
- •Women and newborns with any maternal and/or neonatal risk conditions in the early postpartum period will not be included in the study.
结局指标
主要结局
ALPS-Neo Neonatal Pain and Stress Rating Scale
时间窗: This scala will be evaluated after administering the intramuscular injection.
The scale is a 0-1-2, 3-point Likert type scale consisting of 5 items in one dimension, including the newborn's facial expression, breathing pattern, tone of the extremities, hand and foot activities, and activity level. Measurements are made by observation. A minimum of 0 and a maximum of 10 points are obtained from the scale. As a result of the evaluation, 3-5 points indicate the presence of mild pain and stress, and more than 5 points indicate the presence of severe pain and stress. The higher the stress and pain, the higher the score.
次要结局
未报告次要终点
研究者
sena dilek
Principal Investigator
Kocaeli University