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临床试验/NCT07106606
NCT07106606已完成不适用

The Effect of the Mandala Method in Reduction of Psychological Distress During Anogenital Examination of Sexually Abused Children Aged 9-12

Istanbul University - Cerrahpasa2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2024年5月10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
68
试验地点
2
主要终点
Findings on Anxiety Level

研究概览

简要总结

The goal of this study is evaluating the effectiveness of a mandala-coloring intervention in reducing psychological distress (fear, state anxiety, and related physiological indicators) during anogenital examinations among sexually abused children aged 9-12.

研究设计

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

入排标准

年龄范围
9 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Coming to anogenital examination for the first time,
  • The child and parents have native Turkish language skills and the ability to read and write.

排除标准

  • Sensory loss at a level that prevents communication with the child,
  • Intelligence quotient (IQ) of 55 and below in the records,
  • Has a mental or neurological disability that prevents communication.

结局指标

主要结局

Findings on Anxiety Level

时间窗: Baseline, half an hour before the anogenital examination and immediately after anogenital examination

State Anxiety Inventory for Children used in this study. It was developed by Spielberger to measure state and trait anxiety levels of children aged 9-12 years. Its adaptation into Turkish, validity and reliability study was conducted by Özusta (1993). It consists of two subscales, "state anxiety" and "trait anxiety", each consisting of 20 items. State anxiety subscale: Measures how the child feels "at that moment". Trait anxiety subscale: Measures how the child feels "in general". Both subscales give scores ranging from 20 to 60. In this study, since the change in state anxiety level before and after the anogenital examination will be evaluated, the "state anxiety" subscale was predominantly reflected in the findings. However, although trait anxiety was not examined in pre- and post-examination comparison, this subscale was also examined in the pre-test and post-test measurements. The Cronbach's alpha coefficient of state anxiety subscale was 0.82 and trait anxiety subscale was 0.81

Findings on Fear Level

时间窗: Baseline, half an hour before the anogenital examination and immediately after anogenital examination

Children's Fear Scale: It is a single-item scale consisting of 5 facial expressions. The first facial expression is scored as neutral (0) and the last facial expression as the highest fear (4). It is used to measure the fear level of children before and after the procedure (blood sampling, examination, etc.) (McMurtry et al., 2011). In this study, it was used to determine the change in fear level before and after anogenital examination. Since it includes a single scoring, the reliability coefficient was not calculated.

次要结局

  • Respiratory Rate Finding(Baseline, half an hour before the anogenital examination and immediately after anogenital examination)
  • Cardiac Pulse Finding(Baseline, half an hour before the anogenital examination and immediately after anogenital examination)

研究者

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

Nurgül Bozkurt

Principal Investigator

Istanbul University - Cerrahpasa

研究点 (2)

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