The Effect of Pain Management Education on The Mothers on The Use of Nonpharmacological Practices and Anxiety Level in Heel Stick in Newborn
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- The mothers' use of non-pharmacological methods
研究概览
简要总结
The aim of this study was to determine the effect of non-pharmacological pain management education given to mothers on the use of non-pharmacological methods and anxiety levels of mothers during routine heel blood collection (guthrie screening test) in term newborns.
H0= There was no difference between the intervention group who received non-pharmacological pain management education and the control group's level of anxiety and use of non-pharmacological applications.
H1= The use of non-pharmacological methods is different between the intervention group and the control group that received non-pharmacological pain management education.
H2= Anxiety scores of the intervention group that received non-pharmacological pain management education and the control group were different.
H3= Some characteristics and anxiety levels of mothers have an effect on their use of non-pharmacological methods.
It was carried out between July - September 2021 at the Akşehir State Hospital Gynecology and Obstetrics Clinic, which serves in the Akşehir district of Konya province.
详细描述
In this study was to determine the effect of pain management education on mothers' use of non-pharmacological methods and anxiety levels during newborn heel blood screening.
This study was designed as parallel group, pre-test and post-test randomized controlled trial.
Based on 80% power and 95% confidence level, the sample size was calculated as 32 infants for each group, a total of 64 infants (G*Power 3.1.9.2).
Randomization In this study, stratified randomization method was applied. Eight blocks of four were created with the permutation-blocked randomization method.
With the computer program (randomized.org), the numbers from 1 to 6 were listed 8 times (6,3,5,2,2,6,6,5) and the combinations were sorted according to this group, and assignments were made to the intervention and control groups.
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
In order to avoid bias in the evaluation of the data, the analysis of the coded data in terms of groups was done by an independent statistician. After the statistical analyzes were completed and the research report was written, the researcher explained the coding of the intervention and control groups. In this way, single blindness was achieved.
入排标准
- 年龄范围
- 38 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For newborns;
- •Being a healthy term newborn (born at 38-42 weeks of gestation)
- •A blood sample will be taken for the Guthrie screening test.
- •Having the mother with the baby (Gynecology and Obstetrics Clinic) for mothers;
- •Volunteering to participate in the study
- •Ability to read and write Turkish
- •Being over 18 years old
排除标准
- •For newborns;
- •Having a congenital anomaly
- •Having received any analgesia before the procedure
- •IInability to draw blood in one go for mothers;
- •Rejection of heel blood collection voluntarily
- •Existence of any obstacle that may make communication difficult
结局指标
主要结局
The mothers' use of non-pharmacological methods
时间窗: After the process first 10 minute
The mothers' use of non-pharmacological methods during heel blood collection. These methods are; expressed breast milk, hugging, skin-to-skin contact, cuddling, calming sounds. The cases of using the methods were determined as yes and no for each method.
次要结局
- State anxiety level scores of mothers(Pre-test 5-10 minutes before the process and 10 minutes after the process)
研究者
Fatma Taş Arslan
Professor
Selcuk University