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临床试验/NCT05598372
NCT05598372已完成不适用

The Effect of Two Different Methods on Infant Pain During Vaccination and Maternal Anxiety: a Randomized Controlled Study

Ataturk University2 个研究点 分布在 2 个国家目标入组 90 人开始时间: 2022年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Newborn Infant Pain Scale (NIPS)

研究概览

简要总结

This research was planned to determine the effect of two different methods on infant pain during vaccination and mother anxiety.The study was planned as a randomized controlled trial. The universe of this research consists of parents and their babies who come to Hocabey Family Health Center in Erzincan Center to receive the hepatitis B dose between these dates according to the vaccination calendar. In this study, it is planned to apply shotblocker and lullaby.

详细描述

Type of Study The study was planned as a randomized controlled trial. Population and Sample The universe of this research consists of parents and their babies who come to Hocabey Family Health Center in Erzincan Center to receive the hepatitis B dose between these dates according to the vaccination calendar.

Data Collection Tools Demographic Data Form, Neonatal Pain Scale and State Anxiety Scale Newborn Infant Pain Scale (NIPS): The scale used in the assessment of newborn pain consists of 6 categories. It was developed in 1993 and its validity and reliability in our country was made in 1999. The score obtained from the scale varies between 0-7. Scale ; It consists of five behavioral indicators including facial expression, arm movement, leg movement, crying, alertness, and a physiological indicator that includes breathing.

State Anxiety Inventory: The State Anxiety Scale was developed in 1970, and its Turkish validity and reliability study in our country was conducted in 1994. There are a total of 40 statements in the scale. The first twenty items measure the level of anxiety related to the situation, and each statement is "Not at all" (1), "Somewhat" (2), "Very"(3), "Totally"(4). Reverse coded items; Items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20. Points are added and subtracted according to the reverse and direct coded items in the scale. He states that 0-19 points obtained from the scale mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.

Data Collection Ethics and institutional permissions After the data is received, it will be explained to the participants that the confidentiality of the data will be protected, that personal information will not be requested, that the study is on a voluntary basis, and they will be informed that they can terminate the study at any time. Adolescents who agree to participate in the study will fill in the data collection form, which will take approximately 10 minutes, based on personal notification.

Experimental process In this study, it is planned to apply shotblocker and lullaby. Shotblocker application is not a drug application, it is a small apparatus that performs the blocking process on peripheral nerves to reduce the pain with protruding shape. There is no harm in the application. Another application planned in the study is lullaby. In this application, it is aimed to reduce the baby's pain, which is the painful process, by making the mother who is closest to the baby sing a lullaby. It is very important to compare these two methods. Namely; The effectiveness of two natural and artificial applications will be compared. The fact that this study has not been done before will also provide an important data source to the literature. The planned study will be conducted with 30 lullabies, 30 shotblockers, and 30 babies who come to Hocabey Family Health Center to receive their 6th month Hepatitis B dose and their mothers as a control group to help measure the effectiveness of these two groups. In order to reduce the variables in the application, the nurse who performed the application will be kept constant. For the preliminary application, the principal researcher will be at the center for 1 week and will make observations.

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 (Investigator)

入排标准

年龄范围
1 Month 至 6 Months(Child)
性别
All
接受健康志愿者

入选标准

  • The child does not have a disorder in the cognitive developmental area.
  • It is time to apply the hepatitis B vaccine of the 6th month.
  • Parent giving consent to participate in the study voluntarily and for their child to participate.

排除标准

  • The child has a disorder in the cognitive developmental area.
  • Failure to apply the 6th month hepatitis B vaccine.
  • Parent's voluntarily participating in the study and not giving consent for the child's participation.

结局指标

主要结局

Newborn Infant Pain Scale (NIPS)

时间窗: 9 MONTHS

The scale used in the assessment of newborn pain consists of 6 categories. It was developed in 1993 and its validity and reliability in our country was made in 1999. The score obtained from the scale varies between 0-7. Scale ; It consists of five behavioral indicators including facial expression, arm movement, leg movement, crying, alertness, and a physiological indicator that includes breathing.

State Anxiety Inventory

时间窗: 9 MONTHS

The State Anxiety Scale was developed in 1970, and its Turkish validity and reliability study in our country was conducted in 1994. There are a total of 40 statements in the scale. The first twenty items measure the level of anxiety related to the situation, and each statement is "Not at all" (1), "Somewhat" (2), "Very"(3), "Totally"(4). Reverse coded items; Items 1, 2, 5, 8, 10, 11, 15, 16, 19, 20. Points are added and subtracted according to the reverse and direct coded items in the scale. She states that 0-19 points obtained from the scale mean no anxiety, 20-39 points mean mild, 40-59 points mean moderate, 60-79 points mean severe anxiety, and individuals with a score of 60 and above need professional help.

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

ARZU SARIALİOĞLU

Principal Investigator

Ataturk University

研究点 (2)

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