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临床试验/NCT06404879
NCT06404879已完成不适用

The Relationship Between Pre-operative Parental Anxiety Level and the Child's Anxiety Level and Its Effect on Postoperative Pain in Children Aged 2-6 Years Who Will Undergo Inguinal Area Surgery.

Giresun University2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2025年1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
81
试验地点
2
主要终点
Pain levels of children undergoing surgery

研究概览

简要总结

The aim of this prospective study is to investigate whether the anxiety levels of parents of children aged 2-6 years who will undergo inguinal area surgery have an effect on the child's preoperative anxiety level and postoperative pain level.

详细描述

Hospitalization of children for any health problem or treatment is a complex and difficult process that negatively affects the child and his family and creates stress. Surgical treatment in children can be planned or unplanned, minor or major, invasive or non-invasive, but every type of surgery is considered a stressful experience. Studies have shown that by controlling the anxiety and fear experienced in the preoperative period, children can achieve faster recovery in the postoperative period, better pain tolerance and earlier discharge. For this reason, we aim to contribute to the literature by investigating whether the anxiety levels of the parents of children aged 2-6 who will undergo inguinal area surgery affect the child's preoperative anxiety level and postoperative pain level.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • The child is between the ages of 2-6
  • Patients scheduled for surgery under general anesthesia due to inguinal area pathology
  • Surgery performed as planned
  • There is no mental or neurological disorder in both the mother and the child.
  • There are no vision, hearing or speech problems in both the mother and the child.
  • Parents and children who volunteer to participate in the research
  • Children with ASA I

排除标准

  • Not volunteering to participate in the study (those for whom parental consent cannot be obtained)
  • Those who underwent surgery with a pathology other than the inguinal area
  • Having emergency surgery
  • Children at risk with ASA 2 and above
  • Having a pathology that may cause difficulty in communicating with both the family and the child (such as mental retardation, neurological problem).

研究组 & 干预措施

children group

Are between the ages of 2-6, are planned to undergo surgery under general anesthesia due to inguinal area pathology, No mental or neurological disorders in both mother and child No vision, hearing or speech problems in both mother and child Parents and children who volunteer to participate in the research will be included in the study.

Those who did not volunteer to participate in the study, Undergoing surgery with a pathology other than the inguinal area, Having emergency surgery Children with pathologies (mental retardation, neurological problems, etc.) that may cause difficulty in communicating with both the family and the child will not be included in the study.

干预措施: determining scores with tests (Other)

结局指标

主要结局

Pain levels of children undergoing surgery

时间窗: postoperative period

Pain levels of all children taken to the recovery unit will be measured with the FLACC (Face, Legs, Activity, Cry, Consolabilityscale) score at the 5th, 10th, 20th and 30th minutes.

Anxiety level of the child undergoing surgery

时间窗: preoperative and intraoperative period

According to the m-YPAS (modified Yale Preoperative Anxiety) scale, children's anxiety levels will be calculated in the preoperative waiting room (T1) and when the anesthesia ventilation mask is shown (T4).

Anxiety level of parents

时间窗: preoperative period

It will be measured with STAI-I and STAI-II (State-Trait Anxiety Scale) scale forms.

次要结局

  • heart rate(up to 8 hour postoperative)
  • complication(up to 24 hour postoperative)
  • heart rate(intraoperative period)

研究者

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

Dilek Yeniay

Anesthesiology and Reanimation physician

Giresun University

研究点 (2)

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