Evaluating the Effects of Symptom Monitoring on Physical & Emotional Outcomes During Menopause: A Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Menopausal symptom changes via the Daily Record Keeping (DRK) form
研究概览
简要总结
A recent systematic review suggested that symptom monitoring can result in reductions in menopausal symptoms and improvements in health-related behaviours. To date, no studies have experimentally investigated whether symptom monitoring could be beneficial as an intervention for menopausal women.
One hundred menopausal women were randomised into either a Monitoring-intervention or Control group. A mixed between/ within design was employed, with group membership (i.e., Monitoring-intervention or Control) as the between-subjects component, and time (i.e., baseline and 2-weeks follow-up) as the within-subjects component. Dependent variables included symptom reductions and emotional reactions. Secondary outcomes included help-seeking, communication, medical decision-making, health awareness, self-efficacy, and health anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Menopausal symptom changes via the Daily Record Keeping (DRK) form
时间窗: at baseline and after 2 weeks of symptom monitoring
Changes in menopausal symptom scores after 2-weeks of symptom monitoring, where reductions in symptoms would suggest a beneficial outcomes.
Emotional outcomes via the Daily Record Keeping (DRK) form
时间窗: at baseline and after 2 weeks of symptom monitoring
Changes in emotion scores after 2-weeks of symptom monitoring. The DRK assesses emotional outcomes via specific emotion subscales including Negative Emotions, Positive affect, Anxiety, Depression, Loneliness. Reductions in Negative Emotions, Anxiety, Loneliness, Depression after 2-weeks would suggest benefical effects, as would increases in Positive Affect.
次要结局
- Health Anxiety(at baseline and after 2 weeks of symptom monitoring)
- General Self Efficacy(at baseline and after 2 weeks of symptom monitoring)
- Decision making efficacy(at baseline after 2 weeks of symptom monitoring)
- Health Consciousness(at baseline and after 2 weeks of symptom monitoring)
- Coping preference(Measured at baseline to assess whether coping preference moderated symptom monitoring outcomes)
- Trait neuroticism(Measured at baseline to assess whether trait neuroticism moderated symptom monitoring outcomes)
- Help seeking intentions(at baseline and after 2 weeks of symptom monitoring)
- Health communication(at baseline after 2 weeks of symptom monitoring)