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临床试验/NCT06668285
NCT06668285尚未招募不适用

The Effect of Parental Presence on the Child's Comfort and Physiologic Parameters in PICU

Izmir Katip Celebi University0 个研究点目标入组 50 人开始时间: 2025年4月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
主要终点
comfort scale point

研究概览

简要总结

The study was planned to be conducted and completed within 6 months after ethics committee approval was obtained. The research is a prospective, quasi-experimental study.

The population of the study will consist of children hospitalized in the Pediatric Intensive Care Unit of SBU, Izmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. Randomization of children will be done to determine which children's data will be followed on the relevant visit day.

Physiologic parameters including respiratory rate, pulse rate, oxygen saturation, body temperature, blood pressure and comfort levels of the children will be evaluated just before, during and after the parental visit (1st minute and 5th minute) and compared with those before the parental visit. All observations will be made by the same nurse to avoid bias in the study.

详细描述

There is a growing concern about psychological sequelae in children after hospitalization in the PICU. Despite the prevalence of adverse outcomes such as post-traumatic stress disorder, anxiety and behavioral problems in children after NICU admission, interventions to promote children's comfort have been limited. Children are physically and emotionally vulnerable and exposed to highly harmful environmental stimuli in the PICU. In a study by Johnston et al. in which mothers attempted to touch and talk to children during invasive procedures to reduce children's pain, children recovered faster and mothers experienced reduced anxiety, helplessness and an increased sense of purpose in caring for their children. Melnyk et al. examined the effect of a maternal coping intervention and found less anxiety in mothers and children. Despite these findings, the role of the parent when a child is hospitalized in the PICU is poorly defined. Parents describe the role change in the PICU as a tremendous stressor and report feeling helpless, anxious and fearful at the bedside. They suggest that comforting approaches that mimic home routines may alleviate these feelings and benefit their child.The study is planned to be conducted and completed within 6 months after ethics committee approval was obtained. The research is a prospective, quasi-experimental study.

The population of the study will consist of children hospitalized in the Pediatric Intensive Care Unit of SBU, Izmir Dr. Behçet Uz Pediatric Diseases and Surgery Training and Research Hospital. Randomization of children will be done to determine which children's data will be followed on the relevant visit day.

Physiologic parameters including respiratory rate, pulse rate, oxygen saturation, body temperature, blood pressure and comfort levels of the children will be evaluated just before, during and after the parental visit (1st minute and 5th minute) and compared with those before the parental visit. All observations will be made by the same nurse to avoid bias in the study

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
0 Years 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

comfort scale point

时间窗: Baseline, and first minute of the visit and first/fifth minute after the visit

before, during and after the 1st and 5th minute of the visit

次要结局

  • heart rate(Baseline, and first minute of the visit and first/fifth minute after the visit)
  • saturation(Baseline, and first minute of the visit and first/fifth minute after the visit)
  • respiratory rate(Baseline, and first minute of the visit and first/fifth minute after the visit)
  • blood pressure(Baseline, and first minute of the visit and first/fifth minute after the visit)

研究者

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

ESRA ARDAHAN AKGUL

Asst. Prof.

Izmir Katip Celebi University

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