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The Human Papilloma Virus Effect on Sexual Life (HPVandFSFI)

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ClinicalTrials.gov Identifier: NCT03837028
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Brief Summary:
Human Papilloma Virus (HPV) is one of the most common causes of sexually transmitted diseases and its link with malignancies is well established, especially with anogenital tract cancers (cervical, vaginal, vulvar, anal cancers). HPV 16 and 18 are the most commonly isolated HPV types in cervical cancer, however not all infections with HPV 16 or 18 progress to cancer. After the HPV test has been used in cervical cancer screening, there have been concerns about whether women carry this virus. Although HPV testing may cause negative emotional responses, adverse emotional responses are related to HPV infection rather than testing. In this respect, there were several studies which evaluated the quality of life and psychological responses of women with positive HPV test results and it is known that positive HPV test results cause additional anxiety, distress and negative emotional responses in women. We hypothesized that the awareness of having a sexually transmitted infection in women with HPV and, therefore, a close follow-up and the need for further investigation such as colposcopy can affect their sexual life. In this study, we aimed to observe the changes in sexual function and anxiety of the HPV positive women with validated objective tools after being informed about their co-test results.

Condition or disease Intervention/treatment
Human Papillomavirus Infection Other: FSFI

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Human Papilloma Virus Genotype on Women's Sexual Life
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort Intervention/treatment
HPV 16/18 (+), cytology normal

Women who have HPV 16/18 positivity and normal cytology results in their cervical cancer screening test (co-test) results.

The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.

Other: FSFI
Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.
Other Name: Female Sexual Function Index Questionnaire

HPV 16/18 (+), cytology abnormal
Women who have HPV 16/18 positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.
Other: FSFI
Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.
Other Name: Female Sexual Function Index Questionnaire

non-16/18 HPV (+), cytology abnormal
Women who have non- 16/18 high-risk HPV positivity and abnormal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.
Other: FSFI
Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.
Other Name: Female Sexual Function Index Questionnaire

non-16/18 HPV (+), cytology normal
Women who have non- 16/18 high-risk HPV positivity and normal cytology results in their cervical cancer screening test (co-test) results. The FSFI and BAI questionnaires were performed to the women in this group at the time of admission and two months later.
Other: FSFI
Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.
Other Name: Female Sexual Function Index Questionnaire




Primary Outcome Measures :
  1. Female Sexual Function Index (FSFI) Score [ Time Frame: change from initial overall FSFI and six domain scores at second months. ]
    This is a 19-item questionnaire that covers six domains: desire, arousal, lubrication, and orgasm, satisfaction, and pain. The ranges of the domain scores are as follows: for desire 1.2 - 6.0, for arousal, lubrication, orgasm and pain 0 - 6.0 and for satisfaction 0.8 - 6.0. The higher scores of the six domains indicate better sexual functioning about that domain. The overall FSFI score is obtained by summing the six domain scores. The overall FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning. The change between the initial and second months overall and six domain scores are our first primer outcomes.


Secondary Outcome Measures :
  1. Beck Anxiety Inventory (BAI) Score [ Time Frame: change from initial BAI scores at second months. ]
    The BAI has a total of 21 items. Respondents indicate how much they have been bothered by each symptom over the past week. Responses are rated on a 4-point Likert scale and range from 0 (not at all) to 3 (severely). The total score is calculated by finding the sum of the 21 items. The BAI scores range from 0 to 63 and higher scores are associated with high anxiety levels.



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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women who were attended to our gynecology outpatient clinic due to HPV positivity according to the cervical cancer screening programme were recruited in this study.
Criteria

Inclusion Criteria:

  • women aged between 30 and 50 years
  • sexually active women
  • women who were first diagnosed with high risk HPV positive (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 69, 82)

Exclusion Criteria:

  • postmenopausal women (defined as those with at least 12 consecutive months of amenorrhea with no other medical cause and a follicle- stimulating hormone (FSH) level of 40 mIU/mL)
  • women with chronic disease
  • women with Body Mass Index (BMI) > 30 kg/m2,
  • patients with antidepressant usage or patients with psychiatric disorders
  • women who did not agree to participate in the study after reading the informed consent form
  • women who admitted for follow up due to prior HPV infection
  • women with only low-risk HPV (HPV 6, 11) positivity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03837028


Locations
Turkey
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Turkey, 34147
Sponsors and Collaborators
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Investigators
Principal Investigator: Ismail Alay University Of Health Sciences Bakirkoy Sadi Konuk Training And Research Hospital

Responsible Party: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
ClinicalTrials.gov Identifier: NCT03837028     History of Changes
Other Study ID Numbers: BakirkoyDr.SadiKonuk
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The researchers in the study have not yet taken a decision on IPD sharing.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Papilloma
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
DNA Virus Infections
Virus Diseases
Tumor Virus Infections