Vaginal Penetration Alteration Questionnaire

NCT07080502 | Completed

• 1 other identifier: cquezada01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Assessment, Sexuality, Pain

Outcome Measures

Primary Outcomes (1)

• ✓ 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.

  5 months

Secondary Outcomes (3)

• Establish domains and items that will form the questionnaire for the evaluation of penetration disorders and genito-pelvic pain.

  30 days

• Evaluate the viability and feasibility in the samples of participants and professionals.

  45 days

• Evaluate the valid and reliable of the created questionnaire

  60 days

Interventions

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

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

University of Castilla-La Mancha

Toledo, Toledo, 45001, Spain

Location

MeSH Terms

Conditions

Sexuality; Pain

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Asunción Ferri Morales, PhD

  University of Castilla-La Mancha

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 23, 2025
• Study Start: June 1, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)