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Recruiting NCT06500767

NCT06500767 Psycho-emotional Impact of Preoperative Counselling in Cervico-carcinoma Screening Programs

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Clinical Trial Summary
NCT ID NCT06500767
Status Recruiting
Phase
Sponsor University of Turin, Italy
Condition Physiological Stress
Study Type OBSERVATIONAL
Enrollment 300 participants
Start Date 2022-06-01
Primary Completion 2025-05

Trial Parameters

Condition Physiological Stress
Sponsor University of Turin, Italy
Study Type OBSERVATIONAL
Phase N/A
Enrollment 300
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2022-06-01
Completion 2025-05

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Brief Summary

The communication of an altered Pap smear or positive HPV test has a strong impact on patients on a psychological level. HPV positive women are more likely to have higher level of stress, anxiety, depression and impaired sexual life. The examiner want to establish this impact through different surveys (DASS-21 (Depression Anxiety Stress Scales); PCL-5 (Posttraumatic Stress Disorder Checklist); DTS (Dyadic Trust Scale), CDDQ (Cervical Dysplasia Distress Questionnaire) and MPI (Match Patient Inventory) from the moment the patient receives the news until after completing treatment for her intraepithelial neoplasia.

Eligibility Criteria

Inclusion Criteria: * patients accessing our Colposcopy service from Prevenzione Serena program with an altered pap smear or a two-times positive HPV test * patients with biopsy result of HSIL * ability to fill in surveys via e-mail Exclusion Criteria: * previous access in our Colposcopy service * patients not enrolled in Prevenzione Serena * pregnant patients * inability to fill in surveys via email * partial or total language barrier * denied consent to participate

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