The Assessment of Preoperative Anxiety in Cancer Patients: Validation, Observational, Descriptive Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- To assess the content validity of the SAQ translation
研究概览
简要总结
The study stems from the need to have available effective tools for detecting the anxiety of the cancer patient who has to undergo surgery.
The period leading up to surgery, is characterized by strong emotions that create an upheaval in the work, family and social life of the patient as well as concern about the unknown.
It would be crucial to ensure a personalized nursing care by having scales of assessment specific to the clinical-surgical oncology setting in order to collect the patient's emotions, concerns and fears.
Despite the numerous scales available, many of them have limitations concerning the issues they go to investigate but also concerning the timeframes for compilation, which are often long and laborious so they are difficult to apply.
The study aims to validate in the Italian context the Surgical Anxiety Questionnaire (SAQ) questionnaire, already translated and validated in multiple languages, to detect which factors are the most influential in increasing preoperative anxiety, with the aim of implementing education of the patient and implement strategies and interventions that can reduce anxiety.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In ordinary hospitalization, day surgery, day hospital
- •Age ≥ 18 years
- •Signature of consent participation in the study and personal data collection and processing
- •Good understanding of the Italian language
排除标准
- •Age < 18 years
- •Diagnosis of cognitive dysfunction and psychiatric disorders, or uncooperative patient
- •Difficulty in understanding the Italian language
结局指标
主要结局
To assess the content validity of the SAQ translation
时间窗: up to 1 year
The content validity will be assessed by a panel of 5 experts and rated on a Content Validity Index (CVI). A CVI score \>=0.78 will indicate excellent content validity
To assess criterion validity of the SAQ translation
时间窗: up to 1 year
Criterion validity will be assessed by calculating the correlation between the translated SAQ total score and a validated Hamilton Rating for Anxiety (HAM-A)
To assess the reliability of the SAQ translation
时间窗: up to 1 year
Internal consistency will be measured with Cronbach alpha
To assess the construct validity of the SAQ translation
时间窗: up to 1 year
Confirmatory Factor Analysis will be carried out to assess construct validity. Factor loadings, eigenvalues and explained variance will be reported
次要结局
- Measuring the level of preoperative anxiety in patients undergoing surgery at the Centro di Oncology Reference Center-IRCCS of Aviano (IRCCSCRO Aviano)(up to 1 year)