Effects of Conservative Management Incorporating Urologic Health Promotion and Sleep Health Promotion on Relieving Storage Urinary Symptoms and Poor Sleep in Women With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Sleep Quality
研究概览
简要总结
Women with type 2 diabetes (n=90) experiencing ≥1 storage lower urinary tract symptoms and poor sleep health will be recruited from the outpatient departments or wards/units of the selected hospitals/clinics. Our study aims to examine the effects of conservative management incorporating urologic health promotion and sleep health promotion on relieving storage lower urinary tract symptoms and poor sleep, and on improving urologic health self-management behaviors and health-related quality of life. Women who agree to participate will be randomly assigned into the intervention group A, intervention group B, or comparison group. The intervention group A receives a 4-month conservative management with sleep hygiene related adjustments, pelvic floor muscle training, and urologic health promotion. The intervention group B receives a 4-month conservative management with brief behavioral treatment for insomnia (BBTI), pelvic floor muscle training, and urologic health promotion. The comparison group receives information related to pelvic floor muscle training and urologic health promotion, and receives a brief conservative management related to sleep hygiene adjustments after the completion of data collection. Information related to intervention effects is obtained by a questionnaire, a wristwatch-like actigraphy, and physical activity/diet/voiding/sleep logs from all participants at 4 data collection points: baseline, and 2-, 4-, 6-month follow-ups. Our study hypothesis is that the intervention effects on relieving storage lower urinary tract symptoms and poor sleep, and on improving urologic health self-management behaviors and health-related quality of life in the intervention group A or B are superior to the changes revealed in the comparison group.
详细描述
Women with type 2 diabetes (n=90) experiencing ≥1 storage lower urinary tract symptoms and poor sleep health will be recruited from the outpatient departments or wards/units of the selected hospitals/clinics. Our study aims to examine the effects of conservative management incorporating urologic health promotion and sleep health promotion on relieving storage lower urinary tract symptoms and poor sleep, and on improving urologic health self-management behaviors and health-related quality of life. Women who agree to participate will be randomly assigned into the intervention group A, intervention group B, or comparison group. The intervention group A receives a 4-month conservative management with sleep hygiene related adjustments, pelvic floor muscle training, and urologic health promotion. The intervention group B receives a 4-month conservative management with brief behavioral treatment for insomnia (BBTI), pelvic floor muscle training, and urologic health promotion. The comparison group receives information related to pelvic floor muscle training and urologic health promotion, and receives a brief conservative management related to sleep hygiene adjustments after the completion of data collection. Information related to intervention effects is obtained by a questionnaire, a wristwatch-like actigraphy, and physical activity/diet/voiding/sleep logs from all participants at 4 data collection points: baseline, and 2-, 4-, 6-month follow-ups. Our study hypothesis is that the intervention effects on relieving storage lower urinary tract symptoms and poor sleep, and on improving urologic health self-management behaviors and health-related quality of life in the intervention group A or B are superior to the changes revealed in the comparison group. The effects of the provided intervention on storage lower urinary tract symptoms, sleep quality, urologic health self-management behaviors, and health-related quality of life will be examined by Generalized Estimating Equations procedures with the estimations of effect sizes. Results of Chi-squared tests and descriptive statistics will also be used to present the intervention effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 50-79 years
- •Clinical diagnosis of diabetes >3 months
- •Experiencing ≥1 storage lower urinary tract symptoms in the past 1 month
- •Experiencing poor sleep health in the past 1 month
- •Intact cognition and communication abilities
排除标准
- •Receiving urologic problems related treatments in the past 3 months
- •Receiving sleep problems related treatments in the past 3 months
- •Receiving mental problems related treatments in the past 3 months
- •Having a history of spinal surgery, cardiovascular, renal, or nervous system diseases
- •Having severe mental illness
- •Having physical impairments
结局指标
主要结局
Sleep Quality
时间窗: The 6-month follow-up.
Sleep quality will be measured by the Chinese version of the Pittsburgh Sleep Quality Index. The Chinese version of the Pittsburgh Sleep Quality Index score ranges from 0 to 21; a lower Chinese version of the Pittsburgh Sleep Quality Index score indicates an individual experiencing better subjective sleep quality.
Total nighttime sleep
时间窗: The 6-month follow-up.
Total nighttime sleep will be measured by a wristwatch-like actigraphy. A longer total nighttime sleep duration indicates an individual having better sleep.
Lower urinary tract symptoms
时间窗: The 6-month follow-up.
We will use a lower urinary tract symptoms scale to assess eight common female lower urinary tract symptoms: nocturia, urinary incontinence, increased daytime urinary frequency, urgency, a slow stream, an intermittent stream, hesitancy, and a feeling of incomplete emptying. The total lower urinary tract symptoms score ranges from 0 to 8; a higher total score indicates an individual experiencing more types of lower urinary tract symptoms.
Sleep efficiency
时间窗: The 6-month follow-up.
Sleep efficiency will be measured by a wristwatch-like actigraphy. Sleep efficiency is calculated as the ratio of total nighttime sleep to total time in bed multiplied by 100. A higher sleep efficiency (0 to 100) indicates an individual having better objective sleep quality.
Sleep onset latency
时间窗: The 6-month follow-up.
Sleep onset latency, the length of time that it takes to fall asleep, will be measured by a wristwatch-like actigraphy. A shorter sleep onset latency indicates that an individual is easier to fall asleep.
Wake after sleep onset
时间窗: The 6-month follow-up.
Wake after sleep onset, the amount of time scored as wake between sleep onset and sleep offset, will be measured by a wristwatch-like actigraphy. A shorter wake after sleep onset indicates an individual having better sleep.
次要结局
- Self-management of urologic health(The 6-month follow-up.)
- Health-related quality of life(The 6-month follow-up.)
研究者
Yuan-Mei Liao, RN, PhD
Professor
National Yang Ming Chiao Tung University