跳至主要内容
临床试验/NCT05752344
NCT05752344已完成不适用

Interstitial Cystitis: Monitoring of the Psychic State and Counseling Intervention in the COVID-19 Era

Fondazione Policlinico Universitario Agostino Gemelli IRCCS1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年11月1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
50
试验地点
1
主要终点
Gastrointestinal Symptom Rating Scale (GSCG)

研究概览

简要总结

The target population of this observational study is made up of all patients belonging to the Interstitial Cystitis pathway of the Gemelli University Hospital Foundation - IRCCS, who have accepted to be subjected to remote monitoring and diagnostic investigation. The aim of the study is the evaluation of some outcome parameters at the time of enrollment (T0), and at the end (T1) of subjects affected by Intersitial Cystitis who have carried out a monitoring of the dimensions of the psychic sphere concerning: depression, trait anxiety, state anxiety , well-being, self-efficacy, resilience.The objective is also to evaluate the presence of evolutionary and maturational trends in the mental set-up of the people who participated in the individual counseling intervention.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Recruited subjects have a diagnosis of Interstitial Cystitis and are 18 years of age or older.

排除标准

  • Previous or current intellectual disability in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-
  • Patients who are unable to express consent and who do not have a caregiver who can give it for them.

结局指标

主要结局

Gastrointestinal Symptom Rating Scale (GSCG)

时间窗: 12 months

Administration of psychometric scales

Hospital Anxiety and Depression Scale (HADS)

时间窗: 12 months

Administration of psychometric scales

次要结局

  • Psychological General Well-Being Index (PGWBI)(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mazza Marianna

Medical Doctor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

研究点 (1)

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