Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05869734
Status:
RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-04-26
Brief Title:
Effects of Conservative Management on Relieving Storage Urinary Symptoms and Poor Sleep in Women With Diabetes
Sponsor:
National Yang Ming Chiao Tung University
Organization:
National Yang Ming Chiao Tung University
Study Overview
Official Title:
Effects of Conservative Management Incorporating Urologic Health Promotion and Sleep Health Promotion on Relieving Storage Urinary Symptoms and Poor Sleep in Women With Diabetes
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Women with type 2 diabetes n150 experiencing 1 storage lower urinary tract symptoms and poor sleep health will be recruited from the outpatient departments or wardsunits of the selected hospitalsclinics 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 activitydietvoidingsleep 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
Detailed Description:
Women with type 2 diabetes n150 experiencing 1 storage lower urinary tract symptoms and poor sleep health will be recruited from the outpatient departments or wardsunits of the selected hospitalsclinics 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 activitydietvoidingsleep 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None