본문바로가기



  • Status : Approved
    • First Submitted Date : 2019/04/26
    • Registered Date : 2019/05/03
    • Last Updated Date : 2019/05/02
  • 페이스북공유하기
  • 트위터공유하기
  • 구글플러스공유하기
  • 카카오스토리공유하기
  • 네이버밴드공유하기
  • 출력

1. Background

Background Information
CRIS
Registration Number
KCT0003882 
Unique Protocol ID 40525-201712-BR-93-02 
Public/Brief Title Development and evaluation of sleep promoting program for overactive bladder elderly women 
Scientific Title Development and evaluation of sleep promoting program based on autonomic balance for overactive bladder elderly women  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Not applicable

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number 40525-201712-BR-93-02 
Approval Date 2018-05-01 
Institutional Review Board  
Name Keimyung University Institutional Review Board 
Address 1095, Dalgubeol-daero, Dalseo-gu, Daegu 
Telephone 053-580-6299 
Data Monitoring Committee  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Jooyeon Park 
Title Dr. 
Telephone +82-53-580-3961 
Affiliation Keimyung University 
Address 1095 Dalgubeol-daero, Dalseo-gu, Daegu 42601, Republic of Korea 
Contact Person for Public Queries
Name Jooyeon Park 
Title Dr. 
Telephone +82-53-580-3961 
Affiliation Keimyung University 
Address 1095 Dalgubeol-daero, Dalseo-gu, Daegu 42601, Republic of Korea 
Contact Person for Updating Information
Name Jooyeon Park 
Title Dr. 
Telephone +82-53-580-3961 
Affiliation Keimyung University 
Address 1095 Dalgubeol-daero, Dalseo-gu, Daegu 42601, Republic of Korea 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2018-05-04 , Actual
Target Number of Participant 36
Primary Completion Date 2018-08-27 , Actual
Study Completion Date 2018-08-27 , Actual
Recruitment Status by Participating Study Site 1
Name of Study Site Keimyung University 
Recruitment Status Completed  
Date of First Enrollment 2018-05-04 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Keimyung University 
Organization Type University  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Keimyung University 
Organization Type University  

7. Study Summary

Study Summary Information
Lay Summary Backgroud: Overactive baldder syndrome (OAB) increases with age, and sleep disturbance of elderly people with OAB is a common problem. The purpose of the study was to examine the effects of Biofeedback-Based Sleep Improvement (BBSI) program on urinary symptoms, sleep patterns, autonomic nervous system activity, depression and physical activity in Korean female elderly with OAB. <br /> <br />Methods: A non-equivalent control group pre-post-test design was used. The BBSI program was implemented at the intervention group for 12 weeks, while two educational sessions of general sleep hygiene and lifestyle modification were provided to control group. Using SPSS 23.0, data were analyzed by descriptive analysis, chi-square test, Fisher’s exact test, Mann-Whitney test, and Wilcoxon test. <br /> <br />Hypothesis: <br />1) symptoms of OAB will be different between the experimental and control groups <br />2) sleep patterns will be different between the experimental and control groups <br />3) there will be a difference in autonomic nervous system activity between groups <br />4) amount of physical activity will be different between the experimental and control groups <br />5) level of depression will be different between the experimental and control groups  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Supportive Care    
Phase Not applicable 
Intervention Model Factorial  
Blinding/Masking Open 
Allocation Non-RCT 
Intervention Type Medical Device, Behavioral  
Intervention Description The intervention program consisted of elements known to stabilize ANS including individual intervention, group education, and telephone coaching. The intervention program was provided to promote the sleep of the elderly female with OAB. <br />Individual intervention was conducted with biofeedback training once a week for 20 minutes for 12 weeks. For biofeedback training, a computerized biofeedback system (Procomp, Thought Technology, Canada) was used. By presenting the visual heart rhythm changing with respiration, HRV biofeedback balances the autonomic nervous system by controlling respiratory rate. <br />Group education was conducted once a week for 40 minutes for 12 weeks. The contents of group education consisted of sleep hygiene education, lifestyle correction, Kegel exercise, physical activity, and depression management. Lifestyle modification included body mass index control, caffeine restriction, and alcohol restriction. A pedometer was provided to increase the amount of physical activity. After each round of group training, individual counselling was conducted to encourage participant to achieve appropriate goals. <br />Telephone coaching was conducted to encourage achievement of goals and provide emotional support. We encouraged the use of respiration techniques trained in biofeedback in everyday, and set individual and daily goals for physical activity promotion. Then, we confirmed their practice. The emotional support was composed of contents that the subject’s depression could be improved by allowing the participant to identify and empathize the environment and psychological status. <br />The control group received 40 minutes of training on sleep hygiene and lifestyle modification in the 4th and 8th sessions of intervention, respectively. Sleep hygiene education consisted of same 11 sleep hygiene item as those of the intervention group. Regarding lifestyle improvement, control group was instructed about restriction of caffeine and water intake, pelvic floor exercise, and the necessity of physical activity.  
Number of Arms
Arm 1 Arm Label Biofeedback-Based Sleep Improvement (BBSI) group 
Target Number of Participant 18 
Arm Type Experimental 
Arm Description The intervention program consisted of elements known to stabilize ANS including individual intervention, group education, and telephone coaching. The intervention program was provided to promote the sleep of the elderly female with OAB. Individual intervention was conducted with biofeedback training once a week for 20 minutes for 12 weeks. For biofeedback training, a computerized biofeedback system (Procomp, Thought Technology, Canada) was used. By presenting the visual heart rhythm changing with respiration, HRV biofeedback balances the autonomic nervous system by controlling respiratory rate. Group education was conducted once a week for 40 minutes for 12 weeks. The contents of group education consisted of sleep hygiene education, lifestyle correction, Kegel exercise, physical activity, and depression management. Lifestyle modification included body mass index control, caffeine restriction, and alcohol restriction. A pedometer was provided to increase the amount of physical activity. After each round of group training, individual counselling was conducted to encourage participant to achieve appropriate goals. Telephone coaching was conducted to encourage achievement of goals and provide emotional support. We encouraged the use of respiration techniques trained in biofeedback in everyday, and set individual and daily goals for physical activity promotion. Then, we confirmed their practice. The emotional support was composed of contents that the subject’s depression could be improved by allowing the participant to identify and empathize the environment and psychological status. 
Arm 2 Arm Label control group 
Target Number of Participant 18 
Arm Type Active comparator 
Arm Description The control group received 40 minutes of training on sleep hygiene and lifestyle modification in the 4th and 8th sessions of intervention, respectively. Sleep hygiene education consisted of same 11 sleep hygiene item as those of the intervention group. Regarding lifestyle improvement, control group was instructed about restriction of caffeine and water intake, pelvic floor exercise, and the necessity of physical activity. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Diseases of The genitoruinary system
 Problem: Overactive bladder <br />Overactive bladder (OAB) is characterized by major lower urinary tract dysfunction that causes urinary frequency, nocturia, and urinary urgency irrespective of urge incontinence. In particular, nocturia is the most uncomfortable lower urinary tract symptom among the elderly. It causes sleep disturbances directly and increases the risk of falls and fractures. So we recruited subjects who had sleep disturbance with OAB.
Rare Disease No
Inclusion
Criteria
Gender Female 
Age 65 Year ~ No Limit
Description (1) age ≥ 65 years, female <br />(2) Overactive bladder <br />(3) score of the Overactive Bladder Symptom Scores (OABSS) ≥ 3 and an urgency score ≥ 2 <br />(4) Pittsburgh Sleep Quality Index (PSQI) score ≥ 5 <br />(5) Mini-Mental State Examination (MMSE) ≥ 24 <br />(6) no history of participation in other programs to improve sleep over the last 6 months  
Exclusion Criteria (1) If they took sleeping pills or OAB medication <br />(2) If they had a history of urinary tract infection at the time of the survey <br />(3) If they confirmed neurological, psychiatric disorders or autonomic neuropathy; had diseases that affect autonomic dysfunction  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Not applicable 
Primary Outcome(s) 1 
Outcome Sleep patterns (quality of sleep, sleep satisfaction, sleep efficiency, wake after sleep onset, number of awakenings and number of awakenings in 3 hours after sleep onset 
Timepoint baseline and after 12weeks 
Secondary Outcome(s) 1 
Outcome Urinary symptoms(overactive bladder symptom sevirity, frequency of nocturia) 
Timepoint baseline and after 12weeks 
Secondary Outcome(s) 2 
Outcome Autonomic nervous system activity(Standard deviation of all normal R-R intervals, total power, square root of the mean squared differences of successive N-N intervals, low frequency, high frequency, LF/HF ration, 
Timepoint baseline and after 12weeks 
Secondary Outcome(s) 3 
Outcome Physical activity 
Timepoint baseline and after 12weeks 
Secondary Outcome(s) 4 
Outcome Depression 
Timepoint baseline and after 12weeks 

11. Study Results and Publication

Study Results and Publication Information
Result Registered No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement No 
  • 출력
Quick Link
자주하시는 질문
Q&A
등록절차
입력항목설명집