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

Cystitis, Interstitial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05752344
• Other study ID #: 3499
• Status: Completed
• Start date: November 1, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: February 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 1, 2022
• Est. primary completion date: February 1, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Previous or current intellectual disability in accordance with the Diagnostic and Statistical Manual of Mental Disorders, DSM-5.

• Patients who are unable to express consent and who do not have a caregiver who can give it for them.

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial

Intervention

Other:
• Counseling
Professional Counseling is an activity that aims to improve the client's quality of life. Supporting his strengths and his ability to self-determination, Counseling offers a space for listening and reflection in which to explore difficulties, related to evolutionary processes, transition phase, states of crisis and reinforcement of the ability to choose or change.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Gemelli IRCCS	Rome	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastrointestinal Symptom Rating Scale (GSCG)	Administration of psychometric scales	12 months
Primary	Hospital Anxiety and Depression Scale (HADS)	Administration of psychometric scales	12 months
Secondary	Psychological General Well-Being Index (PGWBI)	Administration of psychometric scales	12 months