Enhancing Men's Awareness of Testicular Diseases (E-MAT): A Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Testicular Self-Examination Behaviour Questionnaire
研究概览
简要总结
Hypothesis: Is it feasible to conduct a definitive trial to test the effect of E-MATVR compared to E-MATE on primary and secondary outcomes among Gaelic Athletic Association (GAA) members (players and coaches)?
The overall aim of this study is to examine the feasibility of conducting a definitive trial to test the effect of an educational intervention to Enhance Men's Awareness of Testicular diseases using Virtual Reality (E-MATVR) among male GAA members.
The effect of E-MATVR will be compared to E-MATE (control) which involves using the same information as E-MATVR delivered as plain text (e.g., PDF) with still images from E-MATVR.
详细描述
- Overall aim
To examine the feasibility of conducting a definitive trial to test the effect of E-MATVR (intervention) compared to Electronic information only, E-MATE (control) on testicular knowledge and testicular self-examination behaviours among male Gaelic Athletic Association (GAA) members (i.e., players and coaches) over three months. 2. Design
According to Eldridge and colleagues, "feasibility study" is an umbrella term including randomised/non-randomised pilot studies and/or other feasibility studies aimed to determine whether a definitive trial can be done, should be done, and if so, how? To answer these questions, we the investigators will conduct a feasibility study comprising a feasibility trial, a study within a trial (SWAT), process evaluation and economic evaluation. This registration only contains the detailed description of the protocol for the feasibility trial.
A Study Within A Trial (SWAT) will be conducted prior to the feasibility trial to determine which recruitment method (Twitter, Facebook or Quick Response [QR] code [via distributed leaflet]) is more efficient and cost effective for recruiting men to this feasibility study. A protocol for the SWAT is available in the SWAT Repository hosted at Queen's University Belfast (insert once available).
A mixed- method process evaluation will be conducted to explore participants' experiences of E-MATVR and E-MATE and potential sources of intervention failure. A protocol for the process evaluation is available in HRB Open Research (insert once available)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Given the differences between the two arms, participants will be aware of the arm they have been randomised into. Outcome assessments will be self-reported and returned to research staff with no information on allocation. Blinding will be maintained throughout data analysis. Unblinding will be facilitated by the independent statistician following completion of the protocol-specified data analysis.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Biological males.
- •Members of the target GAA clubs (GAA players and coaches) since testicular injuries are common in field sports like hurling.
- •Residing in Ireland.
- •Aged 18-50 years (age group at risk for testicular diseases).
排除标准
- •History of seizures.
- •History of motion sickness.
结局指标
主要结局
Testicular Self-Examination Behaviour Questionnaire
时间窗: T0 (baseline), T2 (three months post-test)
Change in participants' behaviours in relation to feeling their own testes and advising at least one man to do the same as assessed by the Testicular Self-Examination Behaviour Questionnaire comprising 3 'Yes' and 'No' type questions. All items are dichotomous: "Yes=1" and "No=0."
Testicular Knowledge Questionnaire
时间窗: T0 (baseline), T1 (immediately post-test), T2 (three months post-test)
Change in participants' knowledge of the normal testes, testicular symptoms, testicular self-examination, and testicular diseases as assessed by the Testicular Knowledge Questionnaire comprising 8 multiple choice questions and 4 'True' and 'False' type questions. All 12 items are dichotomised into "Correct=1" and "Incorrect/Don't know=0." Scores range between 0 and 12. Higher scores indicate greater knowledge.
次要结局
- Testicular Awareness Scale(T0 (baseline), T1 (immediately post-test), T2 (three months post-test))
- Implementations Intentions Scale(T0 (baseline), T1 (immediately post-test), T2 (three months post-test))
- Perceived Risk Item(T0 (baseline), T1 (immediately post-test), T2 (three months post-test))
- General Help-Seeking Questionnaire(T0 (baseline), T1 (immediately post-test), T2 (three months post-test))
研究者
Mohamad Saab
Lecturer
University College Cork