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临床试验/NCT06579586
NCT06579586已完成不适用

The Relationship Between Parental Anxiety and Postoperative Pain and Complications in Children Undergoing Tonsillectomy ± Adenoidectomy

Sumeyra DOLUOGLU1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2024年8月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
145
试验地点
1
主要终点
Evaluation the relationship between parents' anxiety level in the preoperative period and pain perception and complications in children undergoing tonsillectomy ± adenoidectomy

研究概览

简要总结

It is aimed to understand whether high parental anxiety leads to increased pain in children undergoing tonsillectomy ± adenoidectomy surgery and whether it increases the development of complications.

研究设计

研究类型
Observational
观察模型
Family Based
时间视角
Prospective

入排标准

年龄范围
4 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 4-15 years old child patient
  • Willingness to participate in the study by the patient and/or parent
  • No history of psychiatric-mental illness or drug use in the patient and/or parents
  • The patient has no craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
  • No bleeding disorder or disease

排除标准

  • <4 years old, >15 years old paediatric patients
  • Not wanting to participate in the study at any stage of the study
  • History of psychiatric-mental illness or drug use in the patient and parents
  • The patient has craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
  • Having a bleeding disorder or disease

结局指标

主要结局

Evaluation the relationship between parents' anxiety level in the preoperative period and pain perception and complications in children undergoing tonsillectomy ± adenoidectomy

时间窗: 14 days

Pain perception in parents with high anxiety level and in children of these parents who underwent an operation such as adenotonsillectomy that may cause intense pain sensation was questioned by the parent and then by the child at postoperative 6th hour, 24th hour, 1st week and 2nd week.

Determination of preoperative anxiety level in parents of children undergoing tonsillectomy +/- adenoidectomy with State-Trait Anxiety Inventory

时间窗: 21 days

It is a scale consisting of two stages as state and trait anxiety levels. It consists of 40 questions in total, 20 questions each. State anxiety is used to define the level of anxiety in a particular situation, whereas trait anxiety is used to define the anxiety experienced independently of the situation the person is in. Each question is evaluated on a scale of at least 1 (never) and at most 4 points (always) and is expressed in scores ranging from 20-80 points. High scores indicate high levels of anxiety.

Determination of preoperative anxiety level in parents of children undergoing tonsillectomy +/- adenoidectomy with Anxiety Sensitivity Index-3

时间窗: 21 days

Anxiety sensitivity (AS) is characterised as 'an excessive fear of anxiety-related sensations and symptoms that are believed to have harmful physical and/or social consequences'. People with high AS tend to misinterpret sudden, relatively severe and unexplained physical symptoms of anxiety as dangerous, but often tend to avoid them. While '0' means very little, '4' means very much. The score that can be obtained from the scale is between 0-72. The practitioners are asked to indicate to what extent they agree with the statements in each item by taking into account their previous experiences related to the statements in each item, or if they have no experience with that item, they are asked to indicate how they would feel if they experienced that situation. There are no reverse items in the scale. A high score indicates high anxiety sensitivity.

Determination of preoperative anxiety level in parents of children undergoing tonsillectomy +/- adenoidectomy with Pain Catastrophising Scale for Parents

时间窗: 21 days

Pain catastrophising is the tendency to over-focus on and exaggerate the response to painful stimuli and their threat value, and to feel more helpless about the pain experience. It was developed because of the need to relate the degree to which parents catastrophise their children's suffering and the effects on their children's well-being and behaviour. It is assessed with a 5-point scale ranging from 0 (not at all) to 4 (very much). Items from the subscales are added to obtain a total score between 0 and 52; higher scores reflect higher levels of catastrophic thinking in parents.

次要结局

未报告次要终点

研究者

发起方
Sumeyra DOLUOGLU
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sumeyra DOLUOGLU

Principal Investigator

Saglik Bilimleri Universitesi

研究点 (1)

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