Female Sexual DysfunctionCAPEVANCT07080502
Vaginal Penetration Alteration Questionnaire
An observational study of Female Sexual Dysfunction, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
Female sexual dysfunctions reach a prevalence of between 38 and 64%, where various factors are involved. One of the sexual dysfunctions that afflict women are those related to pelvic pain and penetration disorders that are closely related to feelings of anguish and anxiety. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Female Sexual Dysfunction
- What is being tested?
- Application for the creation of a questionnaire on alterations in vaginal penetration
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2023to 30 Oct 2023
- 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 to 60 years
- Women only
- Adult
Study population: This project is aimed at women with complaints of discomfort during vaginal penetration, either during sexual activity, when placing an intravaginal device, or difficulty performing an intracavitary gynecological examination.
Who may be able to join
- Women between the ages of 18 and 60 who present genito-pelvic pain and/or difficulty in sexual activities for a period of 3 months, incapacity and/or difficulty in penetrating some type of intravaginal device, presenting complaints or inability to intracavitary gynecological evaluation
Who cannot join
- Presence of urogynecological infections, vaginal postpartum less than 6 months and 3 months via cesarean section, pelvic surgeries less than 6 months old, cognitive alterations, having neurological problems, exclusive breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Construction and Evaluation of the Psychometric Properties of Vaginal Penetration Impairment Questionnaire
Female sexual dysfunctions reach a prevalence of between 38 and 64%, where various factors are involved. One of the sexual dysfunctions that afflict women are those related to pelvic pain and penetration disorders that are closely related to feelings of anguish and anxiety.
Due to the absence of specific, validated and reliable evaluation tools, the purpose of this work is to create an evaluation instrument for women who suffer from this dysfunction, which is self-administered and where the health professional can obtain clear and precise information about his patient. For this, an observational, multicenter study will be carried out in the city of Toledo, Spain, which consists of three large stages; The first will be the creation of domains and items through expert judgment, then a pilot will be carried out to analyze the viability and feasibility and finally the three psychometric properties will be analyzed: validity, confidence and sensitivity to change.
Read the detailed description
Questionnaires play an important role in practice and research, both as diagnostic clinical tools, measurement of treatment-induced changes, and as research tools when describing a study population and its sexual function. Having a specific, validated, reliable, self-reported tool could facilitate these areas and therefore improve the quality of life of women.
The main objective is:
To build a valid and reliable instrument that is easy to apply for the evaluation of alterations in vaginal penetration and genito-pelvic pain.
An observational, multicenter project is presented that consists of the construction and validation of a Questionnaire in Spanish on Results Perceived by Patients / Health-Related Patient Reported Outcomes.
In stage 1, 10 professionals will be invited to participate, constituting an expert judgment; In stage 2, the pilot will be carried out with 30 women and 2 professionals who can explain the questionnaire to the participants and who can answer questions; In stage 3, a sample size of 10 respondents per item prepared will be required.
- Conditions
- Female Sexual Dysfunction
- Being tested
- Application for the creation of a questionnaire on alterations in vaginal penetration
- Keywords
- Assessment, Sexuality, Pain
- Medical subject headings
- Sexuality, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application for the creation of a questionnaire on alterations in vaginal penetrationOther
Development of domains and items:
Through the judgment of 10 experts, the set of items of each domain will be identified.
Development of the scale:
A pilot will be carried out to guarantee the viability and feasibility of what was created in the previous stage; The questionnaire will be applied to 30. participants.
Evaluation of the scale:
At this stage, the Questionnaire will be applied to a larger sample: 10 participants for each item create. In the same way as the previous stage, the Female Sexual Function Index will be applied together with the created questionnaire.
What is being measured
The primary outcome is the main question the study is designed to answer.
✓ Build a valid and reliable instrument that is easy to apply for the evaluation of alterations in vaginal penetration and genito-pelvic pain.
To achieve this goal it is necessary to meet the 3 sub-goals mentioned below.
Measured: 5 months
Secondary outcomes (3)
Establish domains and items that will form the questionnaire for the evaluation of penetration disorders and genito-pelvic pain.
Through the judgment of 10 experts, the set of elements of each domain will be identified. These professionals will be physiotherapists, gynecologists, midwives and professionals who are experts in creating health scales or questionnaires. Twice as many items should be prepared as it is thought the questionnaire should have. It should be considered that the administration time of the questionnaire does not exceed 10 minutes. The response formats will be of 5 ordered categories where the patient will choose an alternative.
Measured: 30 days
Evaluate the viability and feasibility in the samples of participants and professionals.
A pilot test will be carried out to guarantee the viability and feasibility of what was created in the previous stage, in addition to ensuring that the questions are significant and understandable; The questionnaire will be applied to a small pre-established sample of participants (n=30) and the answers given will be analyzed to determine the optimal number of items/domains. In the same interview, the Female Sexual Function Index will be applied and a document called "Feasibility of the questionnaire for patients" will be given to them with questions about clarity, comprehensibility and adaptation to their condition. In addition to this, other documents will be delivered to the professionals: one called "Feasibility of the questionnaire for professionals" will be provided to the professionals who supervise the administration of the questionnaires to assess the time it has taken the participants to complete the questionnaire or difficulties that have had.
Measured: 45 days
Evaluate the valid and reliable of the created questionnaire
At this stage, the Questionnaire is applied to a larger sample: 10 participants for each item created.
Statistical tests will be applied to analyze the psychometrics of this instrument. The big aspects to analyze at this stage are reliability, validity and responsiveness.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start1 Jun 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asunción Ferri Morales, PhD, Principal investigator, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07080502
- Sponsor's protocol ID
- cquezada01
- Acronym
- CAPEVA
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Evaluation of the Psychometric Properties of Vaginal Penetration Impairment Questionnaire
- ClinicalTrials.gov ID
- NCT07080502
- Acronym / sponsor ID
- CAPEVA / cquezada01
- Conditions
- Female Sexual Dysfunction
- Keywords
- Assessment, Sexuality, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Female sexual dysfunctions reach a prevalence of between 38 and 64%, where various factors are involved. One of the sexual dysfunctions that afflict women are those related to pelvic pain and penetration disorders that are closely related to feelings of anguish and anxiety.
Due to the absence of specific, validated and reliable evaluation tools, the purpose of this work is to create an evaluation instrument for women who suffer from this dysfunction, which is self-administered and where the health professional can obtain clear and precise information about his patient. For this, an observational, multicenter study will be carried out in the city of Toledo, Spain, which consists of three large stages; The first will be the creation of domains and items through expert judgment, then a pilot will be carried out to analyze the viability and feasibility and finally the three psychometric properties will be analyzed: validity, confidence and sensitivity to change.
Detailed description
Questionnaires play an important role in practice and research, both as diagnostic clinical tools, measurement of treatment-induced changes, and as research tools when describing a study population and its sexual function. Having a specific, validated, reliable, self-reported tool could facilitate these areas and therefore improve the quality of life of women.
The main objective is:
To build a valid and reliable instrument that is easy to apply for the evaluation of alterations in vaginal penetration and genito-pelvic pain.
An observational, multicenter project is presented that consists of the construction and validation of a Questionnaire in Spanish on Results Perceived by Patients / Health-Related Patient Reported Outcomes.
In stage 1, 10 professionals will be invited to participate, constituting an expert judgment; In stage 2, the pilot will be carried out with 30 women and 2 professionals who can explain the questionnaire to the participants and who can answer questions; In stage 3, a sample size of 10 respondents per item prepared will be required.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- This project is aimed at women with complaints of discomfort during vaginal penetration, either during sexual activity, when placing an intravaginal device, or difficulty performing an intracavitary gynecological examination.
Key inclusion criteria (1 listed)
- Women between the ages of 18 and 60 who present genito-pelvic pain and/or difficulty in sexual activities for a period of 3 months, incapacity and/or difficulty in penetrating some type of intravaginal device, presenting complaints or inability to intracavitary gynecological evaluation
Key exclusion criteria (1 listed)
- Presence of urogynecological infections, vaginal postpartum less than 6 months and 3 months via cesarean section, pelvic surgeries less than 6 months old, cognitive alterations, having neurological problems, exclusive breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application for the creation of a questionnaire on alterations in vaginal penetrationDevelopment of domains and items: Through the judgment of 10 experts, the set of items of each domain will be identified. Development of the scale: A pilot will be carried out to guarantee the viability and feasibility of what was created in the previous stage; The questionnaire will be applied to 30. participants. Evaluation of the scale: At this stage, the Questionnaire will be applied to a larger sample: 10 participants for each item create. In the same way as the previous stage, the Female Sexual Function Index will be applied together with the created questionnaire. | Other | – |
Primary outcome
✓ Build a valid and reliable instrument that is easy to apply for the evaluation of alterations in vaginal penetration and genito-pelvic pain.
Time frame: 5 months
To achieve this goal it is necessary to meet the 3 sub-goals mentioned below.
3 secondary outcomes
Establish domains and items that will form the questionnaire for the evaluation of penetration disorders and genito-pelvic pain.
Time frame: 30 days
Evaluate the viability and feasibility in the samples of participants and professionals.
Time frame: 45 days
Evaluate the valid and reliable of the created questionnaire
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asunción Ferri Morales, PhD principal investigator
University of Castilla-La Mancha
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Sexual Dysfunction, run by University of Castilla-La Mancha at 1 site in Spain.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jul 2025. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
✓ Build a valid and reliable instrument that is easy to apply for the evaluation of alterations in vaginal penetration and genito-pelvic pain. (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2025.