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
- 1
- 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
- •Reporting at least 2 menopausal hot flushes per day
- •Self-reported peri- or post-menopausal status.
排除标准
- •Under age 18
- •Reported fewer than 2 hot flushes per day
- •Does not self-report peri- or post-menopausal status.
研究组 & 干预措施
Control
This group did not monitor their symptoms every day for the 14 day period, however they did report their symptoms at the beginning and end of the 14 day period
Symptom Monitoring Intervention
This group reported their symptoms every day for 14 days.
干预措施: Symptom Monitoring (Behavioral)
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 communication(at baseline after 2 weeks of symptom monitoring)
- 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)