Understanding Factors Which Affect Willingness to Self-manage a Pessary for Pelvic Organ Prolapse: A Mixed Methods Study Aiming to Improve Access to Pessary Self-management.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Willingness to self-manage a pessary
研究概览
简要总结
Pessary self-management is defined as the patient's ability to remove and reinsert their pessary themselves at home. Previous research has suggested that some women may prefer being able to remove and reinsert their pessary as they wish rather than wait for clinic appointments. At the moment, not enough is known about pessary self-management, particularly what makes someone more or less likely to try pessary self-management. The investigators would like to understand this better to try to help women overcome barriers they might face. This study aims to collect data via both questionnaires and interviews to explore willingness to self-manage a pessary. Using findings from the questionnaires and interviews, a group of women who use pessaries and healthcare professionals who provide pessary care will work together to develop a better way to support women to feel able and willing to manage their pessary in future.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Quantitative phase exclusion criteria
- •Lacking capacity to give implied consent by completion of the questionnaire
- •Has a first or preferred language that is not English
- •Use a shelf, gell-horn or donut pessary
- •Qualitative phase exclusion criteria
- •Lacking capacity to give informed consent
- •First or preferred language that is not English or a language there is an available interpreter for
- •Intervention development phase exclusion criteria Pessary using women
- •Lacking capacity to give informed consent
- •Does not speak English Pessary practitioners
- •Lacking capacity to give informed consent
- •Does not speak English
- •Does not provide pessary care at a minimum of a monthly basis
- •Intervention pilot exclusion criteria
- •Lacking capacity to give informed consent, review the intervention and provide written and/or verbal feedback.
- •Does not speak English
- •Have prior experience self-managing a pessary (defined as previously removing or inserting their pessary, or receiving any pessary self-management teaching or support from a healthcare professional)
结局指标
主要结局
Willingness to self-manage a pessary
时间窗: Through study completion, an average of 1 appointment (1 day)
Women will be asked whether they are willing or not to self-manage a pessary for prolapse. This will be a binary yes, no or not sure answer.
次要结局
- Pessary(Through study completion, an average of 1 appointment (1 day))
- Female genital self-image score (FGSIS)(Through study completion, an average of 1 appointment (1 day))
- Comorbidities(Through study completion, an average of 1 appointment (1 day))
- Education status(Through study completion, an average of 1 appointment (1 day))
- Length of pessary management(Through study completion, an average of 1 appointment (1 day))
- Ethnicity(Through study completion, an average of 1 appointment (1 day))
- Post code(Through study completion, an average of 1 appointment (1 day))
- Age(Through study completion, an average of 1 appointment (1 day))
- Self-management experience(Through study completion, an average of 1 appointment (1 day))
- Self-management status(Through study completion, an average of 1 appointment (1 day))