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临床试验/NCT07660159
NCT07660159已完成不适用

THE EFFECT OF TWO DİFFERENT PAİN MANAGEMENT EDUCATİON METHODS PROVİDED FOR HEEL PRİCK PROCEDURES ON MOTHERS' USE OF NONPHARMACOLOGİCAL METHODS, ANXİETY LEVELS, AND NEONATAL PAİN

Kocaeli University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2025年2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
入组人数
75
试验地点
1
主要终点
mothers' anxiety

研究概览

简要总结

The aim of this research is to evaluate the effects of two different methods of education (verbal instruction + written brochure and verbal instruction + AI-assisted video presentation) given to new mothers on neonatal pain management, their use of non-pharmacological methods, anxiety levels, and neonatal pain, and to examine the relationship between them.

Research Questions Do two different pain management education methods affect mothers' use of nonpharmacological methods? Do two different pain management education methods affect mothers' anxiety levels? Do two different pain management education methods affect neonatal pain during heel prick procedures? Is there a difference between verbal instruction combined with a written brochure and verbal instruction combined with video demonstration in terms of mothers' use of nonpharmacological methods? Is there a difference between verbal instruction combined with a written brochure and verbal instruction combined with video demonstration in terms of maternal anxiety levels? Is there a difference between verbal instruction combined with a written brochure and verbal instruction combined with video demonstration in terms of neonatal pain during heel prick procedures? Is there a relationship between mothers' use of nonpharmacological methods and their anxiety levels? Is there a relationship between mothers' use of nonpharmacological methods and neonatal pain levels?

详细描述

The International Association for the Study of Pain has defined pain as "an unpleasant sensory and emotional experience associated with actual or potential injury" (IASP, 1979). However, it has been noted that this definition is insufficient in newborns, who lack verbal communication, as they cannot express pain and have no opportunity to refuse treatment (Anand & Craig 1996), and later, pain was redefined as an unpleasant sensory and emotional experience associated with or similar to actual or potential tissue damage (Raja et al. 2020). Newborns are frequently exposed to painful procedures during diagnostic and therapeutic processes such as routine newborn screenings, blood glucose measurement, and immunization (WHO, 2017). It has been reported that painful interventions experienced in early childhood can lead to short-term physiological changes as well as neurodevelopmental consequences (AAP 2016; Hatfield & Ely, 2015). Furthermore, it has been shown that exposure to painful stimuli in early life may be associated with stress responses and behavioral changes later in life (Taddio et al. 1997). The first step in pain management is the accurate assessment of pain. Therefore, it is important to use validated scales in the assessment of pain in newborns and to apply appropriate pain management methods (Costa et al. 2017; Rocha et al. 2021). Although pharmacological methods are frequently used in pain management in infants, interest in non-pharmacological methods has increased in recent years due to the physiological immaturity of newborns and possible side effects of drugs (Allegaert and van den Anker, 2017). Methods such as holding, non-nutritive sucking, breastfeeding, sucrose/glucose solutions, skin-to-skin contact, and swaddling are reported to be effective in reducing pain scores during short-term painful procedures (Mangat et al. 2018). The American Academy of Pediatrics recommends that families be actively involved in the prevention and management of pain in newborns (American Academy of Pediatrics, 2016). Within the framework of the family-centered care approach, parental participation in the care of their babies is encouraged, and it is reported that the education given to parents increases the use of pain management methods (Taddio et al. 2013; Campbell-Yeo et al. 2017; Chambers et al. 2020). However, studies that evaluate the effects of different education methods given to mothers during heel prick blood sampling, one of the frequently performed painful procedures in newborns, on mothers' anxiety levels, non-pharmacological method use, and newborn pain are limited. Therefore, this study aimed to determine mothers' approaches to pain management during heel prick blood sampling performed within the scope of newborn screening and to evaluate the effects of two different education methods given before the procedure on mothers' use of non-pharmacological methods, anxiety levels, and newborn pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 49 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Being 19 years of age or older Being a primiparous mother Voluntarily agreeing to participate in the study Not having a psychiatric diagnosis Having a healthy term newborn baby (born at 38-42 gestational weeks) Having a blood sample taken for the Guthrie screening test

排除标准

  • Lack of Turkish reading and comprehension skills in the participant Incomplete completion of the survey form Having a baby with a congenital anomaly Having received any analgesia before the procedure Refusal to have a blood sample taken for the Guthrie screening test History of the baby staying in intensive care

研究组 & 干预措施

Control Group

No Intervention

The mothers underwent the clinic's routine procedure.

verbal and brochure-based education

Experimental

Mothers were given training on non-pharmacological pain management through verbal and brochure education.

干预措施: verbal and brochure-based education (Other)

verbal and AI-assisted video training

Experimental

Mothers were given training in non-pharmacological pain management through verbal instruction and AI-assisted video training.

干预措施: verbal and AI-supported video training (Other)

结局指标

主要结局

mothers' anxiety

时间窗: between 24 and 72 hours after birth

Those scoring between 20 and 80 points indicate anxiety.

次要结局

  • Newborn Pain Scale (NIPS)(between 24 and 72 hours after birth)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sinem Öztürkler

Assist. Prof

Kocaeli University

研究点 (1)

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