The Use of Chaperone in Routine First Visit Anorectal Examination of Women
试验速览
- 阶段
- 不适用
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Preference to have or not chaperone during anorectal examination.
研究概览
简要总结
Background and aim: The use of chaperone in routine anorectal examination of women attending to Coloproctology clinics has not been studied to this date. The aim of this study is to compare the patients' perception and preference regarding the presence of a chaperone during their first anorectal examination. Patients and methods: adult women will be randomly selected to be examined with or without the presence of a female chaperone. After that, they will answer a questionnaire form about how they feel during the examination and whether or not they would prefer having or not a chaperone present in that clinical situation. The patients will prospectively enrolled in one of the two groups of this randomized trial during a period of two years.
详细描述
The use of chaperone in routine anorectal examination of women attending to Coloproctology clinics has not been studied to this date. However, there are some guidance saying says that doctors should offer the patient the option of a chaperone wherever possible before conducting an intimate examination. The aim of this study is to compare the female patients' perception and preference regarding the presence of a chaperone during their first anorectal examination conduct by a male physician. Adult women will be investigated during their first visit to a Coloproctology Clinic at University Hospital. Only senior professionals will be examining the patients. This will be a prospectively randomized trial. Patients will be selected to be examined with or without the presence of a female chaperone. After that, they will answer a questionnaire form about how they feel during the examination and whether or not they would prefer having or not a chaperone present during the anorectal examination. The enrollment period will be two years from July 2018. Sample size estimated for the study is 188 patients (94 in each study group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adult female patients;
- •first visit to our Coloproctology clinic;
- •signed consent form
排除标准
- •patients previously submitted to anorectal examination;
- •refusal of participation.
结局指标
主要结局
Preference to have or not chaperone during anorectal examination.
时间窗: Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).
Assessed by the question: "Would you rather have taken the exam in the (without) presence of another person (woman)?". There are 3 possible answers: yes, no, indifferent.
次要结局
- Degree of comfort during anorectal examination.(Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).)
- Evaluation of the anorectal examination according to the presence or absence of a chaperone(Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).)
- Preference to have a chaperone in a future anorectal examination(Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).)
- Patients's feeling about having or not chaperone during anorectal examination.(Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).)
- Feeling of protection during anorectal examination according to the presence or absence of a chaperone(Only one assessment by a questionnaire right at the end of clinical visit (1 minute after completing the visit).)