Evaluation of the Correlation Between Psychological Intervention, Including Providing Knowledge and Tools for Problems Solving, and the Anxiety Level of Female Patients Arriving to ACTH LRH Test - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Anxiety Questionnaire
研究概览
简要总结
Over 20% of the population is reporting on "white coat syndrome", manifested as anxiety symptoms and elevated BP during interaction with medical staff. It is estimated that, throughout the life span of children, approximately 15-20% will suffer from some form of a trauma relating to an interaction with health provider. The proposed study aims is to evaluate the correlation between a single preliminary psychological intervention, including providing knowledge and tools for problems solving, and the anxiety level in female patients arriving to Adrenocorticotropic Hormone (ACTH) and Lutenising Releasing Hormone (LRH) test in comparison to the anxiety in patients arriving to the same test without psychological intervention. 20 female patients arriving to ACTH LRH test for puberty stage assessment (performed as part of routine medical care) will be recruited to the study and will be randomized to one of 2 groups. Participants in the intervention group (10 patients) will be required to arrive with their parents an hour prior to the test and will receive a preliminary psychological intervention. The control group will arrive to the ACTH LRH test on the scheduled time and will not receive psychological intervention
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
- 7 Years 至 12 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Girls referred to ACTH LRH or LRH test
- •Age 7-12 years old
- •Ability to answer questionnaire independently (hebrew language only)
排除标准
- •Mental disability
- •Girls who were referred to the test in purpose of evaluation of the pituitary adrenal axis after prolong steroids therapy.
- •Girls with chronic disease that required frequent hospitalization (over 4 times per year)
结局指标
主要结局
Anxiety Questionnaire
时间窗: Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours
次要结局
- Parents Treatment Satisfaction Questionnaire(Baseline (Visit 1), At the end of the ACTH LRH test, 2 hours)