Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-01-09 @ 12:59 PM
Study NCT ID:
NCT07080502
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2025-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaginal Penetration Alteration Questionnaire
Sponsor:
University of Castilla-La Mancha
Organization:
Study Overview
Official Title:
Construction and Evaluation of the Psychometric Properties of Vaginal Penetration Impairment Questionnaire
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPEVA
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: