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Physiological StressNCT06500767

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

An observational study of Physiological Stress and HPV Infection, run by University of Turin, Italy at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
How many people
300 participants
Where
1 siteItaly
Study dates
1 Jun 2022to Jul 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: All the patients accessing our Colposcopy service from Prevenzione Serena program with an altered pap smear or a two-times positive HPV test

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Italy1 site, 1 recruiting

  • Ospedale Sant'Anna

    Turin, TO, 10126

    Mario Preti, MD, 3406175388, mario.preti@unito.it

    Recruiting

Other trials in Italy

About this study

Official title: Psycho-emotional Impact of Preoperative Counselling in Cervico-carcinoma Screening

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.

Medical subject headings
Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06500767
Study groupRoleWhat they receive
counselling Areceiving counselling prior to surgery in person
counselling Breceiving counselling prior to surgery via telephone and with a video

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DASS-21 (Depression Anxiety Stress Scales).

    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

    Measured: 3 to 6 months

  2. PCL-5 (Posttraumatic Stress Disorder Checklist);

    Not at all 0 A little bit 1 Moderately 2 Quite a bit 3 Extremely 4 Disturbing, unwanted memories of the stressful experience? Repeated dreams of it? Feeling or acting as if it were re-happening? Feeling very upset when reminded of it? Strong physical reactions when reminded? Avoiding memories or thoughts related to the experience? Avoiding external reminders? Trouble remembering important parts of it? Strong negative beliefs about yourself, others, or the world? Blaming yourself or others for the experience or its aftermath? Strong negative feelings like fear, horror, anger, guilt, or shame? Loss of interest in activities you used to enjoy? Feeling distant or cut off from others? Trouble experiencing positive feelings? Irritable behavior, angry outbursts, or acting aggressively? Taking too many risks or doing things that could harm you? Being "superalert"? Feeling easily startled? Difficulty concentrating? Trouble falling asleep?

    Measured: 3 to 6 months

  3. DTS (Dyadic Trust Scale)

    Strongly Disagree Disagree Neutral Agree Strongly Agree

    1 2 3 4 5

    Please rate the extent to which you agree or disagree with each statement:

    My partner is primarily interested in his/her own welfare. 1 2 3 4 5 There are times when my partner cannot be trusted. 1 2 3 4 5 My partner is perfectly honest and truthful with me. 1 2 3 4 5 I feel that I can trust my partner completely. 1 2 3 4 5 My partner is truly sincere in his/her promises. 1 2 3 4 5 I feel that my partner does not show me enough consideration. 1 2 3 4 5 My partner treats me fairly and justly. 1 2 3 4 5 I feel that my partner can be counted on to help me. 1 2 3 4 5 My partner behaves in a very consistent manner. 1 2 3 4 5 My partner is always honest with me.

    1 2 3 4 5

    Scoring:

    To determine the trust level, reverse score the negatively worded items (1, 2, and 6). For these items, change the scoring as follows: 1 becomes 5, 2 becomes 4, 3 stays the same, 4 becomes 2, and 5 becomes 1.

    Measured: 3 to 6 months

  4. CDDQ (Cervical Dysplasia Distress Questionnaire)

    Not at all A little bit Moderately Quite a bit Extremely 0 1 2 3 4

    Please rate how much you have been distressed by each of the following in the past week, including today:

    Worrying about the possibility of developing cancer. 0 1 2 3 4 Feeling anxious about future medical procedures. 0 1 2 3 4 Feeling down or depressed about your diagnosis. 0 1 2 3 4 Concerns about the impact of the diagnosis on your sexual relationships. 0 1 2 3 4 Feeling stressed about having to undergo regular follow-up tests. 0 1 2 3 4 Worrying about how others might react to your diagnosis. 0 1 2 3 4 Feeling upset about the uncertainty of your health status. 0 1 2 3 4 Concerns about fertility or future pregnancies. 0 1 2 3 4 Feeling isolated or alone in dealing with your diagnosis. 0 1 2 3 4 Experiencing intrusive thoughts about your condition. 0 1 2 3 4

    Measured: 3 to 6 months

  5. MPI (Match Patient Inventory)

    Strongly Disagree 1Disagree2Neutral3Agree 4Strongly Agree5Impossible to Evaluate6

    The doctor:

    Greeted me in a way that made me feel comfortable. Discussed the reason(s) that brought me here today.

    Encouraged me to express my thoughts about my health problem. Listened carefully to what I had to say.

    Understood what I had to say. the doctor explained what was done and why. Explained the necessary lab tests Discussed treatment options with me. Gave me all the information I wanted.Checked whether the treatment plan(s) were acceptable to me. Gave explanations regarding any medications, including possible side effects.

    Encouraged me to ask questions. Answered my questions and concerns. Involved me in decisions as much as I wanted. Discussed the next steps, including any follow-up plans. Made sure I understood everything.

    Showed interest and concern for me as a person. Spent the right amount of time with me. Overall, I am satisfied with today's visit with the doctor

    Measured: 3 to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2024
  2. Study start1 Jun 2022
  3. Primary completionMay 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06500767
Sponsor's protocol ID
University of Torino
Status last verified
Jul 2024
First submitted
16 Jun 2023
Last updated
15 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Physiological Stress and HPV Infection, run by University of Turin, Italy at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DASS-21 (Depression Anxiety Stress Scales). (time frame: 3 to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06500767.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2024.

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