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

NCT ID: NCT06500767

Last Updated: 2024-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Physiological Stress HPV Infection Papilloma Viral Infection

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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counselling A

receiving counselling prior to surgery in person

No interventions assigned to this group

counselling B

receiving counselling prior to surgery via telephone and with a video

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Turin, Italy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ospedale Sant'Anna

Turin, TO, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Mario Preti, MD

Role: primary

3406175388

Other Identifiers

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University of Torino

Identifier Type: -

Identifier Source: org_study_id

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