Construction and Evaluation of the Psychometric Properties of Vaginal Penetration Impairment Questionnaire
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- ✓ Build a valid and reliable instrument that is easy to apply for the evaluation of alterations in vaginal penetration and genito-pelvic pain.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
✓ Build a valid and reliable instrument that is easy to apply for the evaluation of alterations in vaginal penetration and genito-pelvic pain.
时间窗: 5 months
To achieve this goal it is necessary to meet the 3 sub-goals mentioned below.
次要结局
- 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)