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临床试验/NCT07151131
NCT07151131尚未招募不适用

Cartoons and Reflexology for Postoperative Nausea, Pain, and Anxiety in Children

Sakarya University0 个研究点目标入组 105 人开始时间: 2025年9月1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
105
主要终点
Anxiety Tool: Preoperative Anxiety Scale

研究概览

简要总结

Preoperative anxiety arises as a physiological response of the body to stressors and is pathophysiologically associated with stimulation of the autonomic nervous system and increased catecholamine release (Durgut, 2021). As a result, elevated levels of cortisol and epinephrine in the body can cause cytotoxic effects at the cellular level. This physiological mechanism may lead to hypertension, arrhythmia, tachycardia, and tachypnea in children (Dehghan et al., 2019; Durgut, 2021).

Due to these effects, recent evidence-based studies have focused on the use of non-pharmacological approaches with fewer side effects to manage anxiety in children (Kavak et al., 2019). According to the literature, various techniques have been identified as effective interventions for reducing preoperative anxiety in children, including:

Listening to music,

Playing games,

Using dramatic puppets,

Interactive play,

Virtual reality applications,

Watching cartoons,

Playing favorite video games,

Video presentations,

Hospital clowns,

Storybooks,

Visual and auditory stimuli

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
Single (Outcomes Assessor)

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Participants were included in the study if they met all of the following conditions:
  • The child was hospitalized in the pediatric surgical clinic for a planned (elective) surgery,
  • The child was aged between 4 and 6 years,
  • The child was scheduled to receive general anesthesia,
  • Neither the child nor the primary caregiver had any visual, hearing, or cognitive impairments,
  • The child had no anatomical abnormalities or tissue integrity issues in the feet,
  • Verbal assent was obtained from the child,
  • Both parents provided written and verbal informed consent for participation,
  • Both the child and parents were willing and voluntarily agreed to participate in the study.

排除标准

  • Participants were excluded from the study if any of the following conditions occurred:
  • Postoperative bleeding tendency developed in the child,
  • The child required postoperative intensive care,
  • A high-risk complication developed after surgery,
  • The child failed to initiate spontaneous respiration postoperatively,
  • Intraoperative death (exitus) occurred,
  • The child experienced prolonged unconsciousness due to anesthesia,
  • The child underwent surgical procedures involving the feet.

结局指标

主要结局

Anxiety Tool: Preoperative Anxiety Scale

时间窗: Baseline, Postoperative 60th and 120th minutes

Pain Tool: Wong-Baker FACES Pain Rating Scale

时间窗: Postoperative 60th and 120th minutes

Nausea Tool: standardized observational nausea scale

时间窗: Postoperative 60th and 120th minutes

次要结局

未报告次要终点

研究者

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

öznur tiryaki

Associate Professor

Sakarya University

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