Clinical trial · Observational
Psycho-emotional Impact of Preoperative Counselling in Cervico-carcinoma Screening Programs
Psycho-emotional Impact of Preoperative Counselling in Cervico-carcinoma Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV Infection | — | UNRESOLVED | — |
| Papilloma Viral Infection | — | UNRESOLVED | — |
| Physiological Stress | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- counselling A
- description
- receiving counselling prior to surgery in person
- label
- counselling B
- description
- receiving counselling prior to surgery via telephone and with a video
Primary outcomes (5)
- measure
- DASS-21 (Depression Anxiety Stress Scales).
- timeFrame
- 3 to 6 months
- description
- 0 Did not apply at all 1 Applied to some degree 2 Applied to a considerable degree 3 Applied very much. I found it hard to wind down; I was aware of dryness of my mouth;I couldn't seem to experience any positive feeling at all I experienced breathing difficulty ; I found it difficult to work up the initiative to do things ;I tended to over-react to situations;I experienced trembling ;I felt that I was using a lot of nervous energy; I was worried about situations in which I might panic; I felt that I had nothing to look forward to; I found myself getting agitated; I found it difficult to relax ; I felt down-hearted and blue ; I was intolerant of anything that kept me from getting on with what I was doing ; I felt I was close to panic ; I was unable to become enthusiastic about anything ; I felt I wasn't worth much as a person ; I felt that I was rather touchy; I was aware of my heart in the absence of physical exertion ; I felt scared without reason; i felt that life was meaningless
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available