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临床试验/NCT04225962
NCT04225962已完成不适用

Intimacy of Women With Cystic Fibrosis

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 211 人开始时间: 2019年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
211
试验地点
1
主要终点
Assessment of specific intimate disorders of patients with cystic fibrosis

研究概览

简要总结

The intimate life of patients with cystic fibrosis has not been the subject of specific research, it is even left behind in favor of respiratory, digestive or endocrinological dysfunctions endangering these patients. After 16 years of practice, it is significant that this subject is problematic, painful but difficult to tackle; No doubt just as much on the side of caregivers: this question has never found its way into team exchanges, it seems to be evaded doubtless difficult or too intimate to welcome. These disorders arise from the effects of the disease on the health of the mucous epithelial tissues also located in the genital area. These difficulties are more closely approached by the difficulties of procreation; PMA allows them to get around them, nevertheless making it possible to be a parent, with the residual frustration of a satisfactory sex life: a deaf "addition", adding to many care constraints.

It is therefore in terms of sexual health and quality of sexual life that it is desirable to shed light on this aspect of cystic fibrosis in women.

Bibliographic research confirms this approach: this subject is not explored, the rare publications concern the vulnerability of the cervix or the difficulty on both sides of tackling this subject.

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
Female
接受健康志愿者

入选标准

  • Major women with cystic fibrosis
  • Tracked in the various CRCMs in France,
  • Having or having had sexual intercourse,
  • Having previously been informed of the aims and confidentiality of this research and not having opposed their participation.

排除标准

  • Major women with cystic fibrosis whose state of health (acute episode of their disease or worsening phase) does not lend itself to such a collection
  • Adult women with cystic fibrosis who are unable to receive the information and make a non-objection

结局指标

主要结局

Assessment of specific intimate disorders of patients with cystic fibrosis

时间窗: 12 months

Passing a questionnaire to assess patients' intimate quality of life. The responses to binary qualitative variables will be described by proportions. The responses to the 5-modality ordinal qualitative variables will be described by the median and the range (minimum and maximum). Continuous quantitative variables will be described by the mean and its standard deviation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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