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- Status : Approved
- First Submitted Date : 2019/04/26
- Registered Date : 2019/05/03
- Last Updated Date : 2019/05/02
| 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 |
| 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 |
| 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 | |
| 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 |
| Source of Monetary/Material Support 1 | ||
|---|---|---|
| Organization Name | Keimyung University | |
| Organization Type | University | |
| Project ID | ||
| Sponsor Organization 1 | ||
|---|---|---|
| Organization Name | Keimyung University | |
| Organization Type | University | |
| 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 |
|---|
| 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 | 2 | |
| 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. | |
| 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 | |
| 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 |
| Result Registered | No |
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| Sharing Statement | No |
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