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Vaginal Penetration Alteration Questionnaire

NCT07080502 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-07-23

No results posted yet for this study

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.

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.

Conditions

  • Female Sexual Dysfunction

Interventions

OTHER

Application for the creation of a questionnaire on alterations in vaginal penetration

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.

Sponsors & Collaborators

  • University of Castilla-La Mancha

    lead OTHER

Principal Investigators

  • Asunción Ferri Morales, PhD · University of Castilla-La Mancha

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-01
Primary Completion
2023-10-30
Completion
2023-10-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07080502 on ClinicalTrials.gov