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临床试验/NCT04894487
NCT04894487已完成不适用

The Effect of The Use of Baby Mobile Accompanied With Brhams Lullaby On The Infant's Physiologicak Parameters and Pain Level During Sternum Dressing

Okan University1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2020年8月25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
发起方
入组人数
76
试验地点
1
主要终点
The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's pain levels during sternum dressing

研究概览

简要总结

The study was conducted experimentally in a randomized controlled manner in order to determine the effect of the use of baby mobile accompanied by Brahms Lullaby on physiological parameters and pain level during sternum dressing in babies. The research was carried out with 76 babies followed up in the Pediatric Cardiovascular Surgery Intensive Care Unit between August 2020 and February 2021 (Baby Mobile Group accompanied by Brahms Lullaby: 38, Control Group: 38). Data were collected by using the "Baby Monitoring Form" and "FLACC Pain Scale".

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
1 Month 至 12 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Being 1-12 months
  • •Being volunteer for research
  • •Operated for Congenital Heart Disease
  • •Got Sternum incision
  • •No other chronic illness
  • •No similar surgical experiment before
  • •No visual impairment
  • •No hearing impairment
  • •No mental or neurological impairment
  • •Hospitalization experience

排除标准

  • 未提供

研究组 & 干预措施

Control Group

No Intervention

The babies have got sternum incision after the pediatric cardiac surgery. Experiment is about the dressing of the sternum incision. There is no extra intervention during sternum dressing at control group like routine of pediatric cardiovascular surgery intensive care clinic. Saved pain scores and physiological parameters and pain scores; just before the sternum dressing, just after sternum dressing and after the 15 minutes sternum dressing.

THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABIES GROUP

Experimental

Baby mobile and Brahms Lullaby started before the 10 minutes of sternum dressing process and controlled permanence of the baby mobile and Brahms Lullaby during sternum dressing. Saved pain scores and physiological parameters and pain scores; just before the sternum dressing, just after sternum dressing and after the 15 minutes sternum dressing.

干预措施: THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY (Behavioral)

结局指标

主要结局

The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's pain levels during sternum dressing

时间窗: 30 minutes

FLACC Pain Scale was used for determain pain level in this research. Scale got 0 to 10 points (0 (Bad) to 10 (Good)).

The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's SpO2 during sternum dressing

时间窗: 30 minutes

SpO2

The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's blood pressure sternum dressing

时间窗: 30 minutes

blood pressure- mmHg

The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's heart beat during sternum dressing

时间窗: 30 minutes

heart beat- bpm

The effects of the use of baby mobile accompanied with Brahms Lullaby on the baby's body temperature during sternum dressing

时间窗: 30 minutes

body temperature-- degrees centigrade

次要结局

未报告次要终点

研究者

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

Kamil KARAKAYA

Principal Investigator, RN, MSc

Okan University

研究点 (1)

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