Urinary IncontinenceNCT06287658
The Effect of Kegel Exercise and Ba Duan Jin Applications on Premenopausal Women With Urinary Incontinence
A study testing Training on Kegel exercise and Ba Duan Jin applications online and training on Kegel exercises and Ba Duan Jin applications after the research is completed in people with Urinary Incontinence and Menopause, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effects of Kegel exercise and Ba Duan Jin applications applied to premenopausal women with urinary incontinence on quality of life and psychological well-being. Read more about this study
- Who is it for?
- Ages 45 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Incontinence, Menopause, Wolman Disease
- What is being tested?
- Training on Kegel exercise and Ba Duan Jin applications online and training on Kegel exercises and Ba Duan Jin applications after the research is completed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Agreeing to participate in the study
- Having a complaint of urinary incontinence
- Being a woman between the ages of 45-55
- Being communicable
- Having a device (phone, tablet, computer) that can participate in online conversations
- Being in the premenopausal period
Who cannot join
- Women who do not complain of urinary incontinence
- Women in menopause
- Women who left unanswered questions on their scale forms
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Tuba Yilmaz Bulut
Kocaeli
TUBA YILMAZ BULUT, Dr., 05343435109, tuba_yilmaz1991@hotmail.com
About this study
Official title: The Effect of Kegel Exercise and Ba Duan Jin Applications on Quality of Life and Psychological Well-Being Applied to Premenopausal Women With Urinary Incontinence
This study aimed to determine the effects of Kegel exercise and Ba Duan Jin applications applied to premenopausal women with urinary incontinence on quality of life and psychological well-being. Study Group of the Research: Premenopausal women between the ages of 45-55 who come to the family health center with any complaint and have urinary incontinence. The research will be conducted as a randomized pre-test, post-test and control group intervention study design. The research will be conducted with women aged 45-55 with urinary incontinence who came for examination for any reason to a Family Health Center in Sinop between March 2024 and July 2024. According to the power analysis, the number of participants was calculated to be at least 54 when the type 1 error was taken as 0.05, the power was 0.95 and the effect size was medium (0.25) for the two-group design with two repeated measurements. To prevent possible data loss, the sample size was increased by 10% and the total number of participants was determined as 60. A total of 60 women, 30 experimental and 30 control, coming to the Family Health Center will be randomly included in the study. No information, Kegel exercise program and Ba Duan Jin applications will be given to the women in the experimental group, and no intervention will be given to the control group during the research process. Participants will be assigned to 2 groups: experimental and control. Those who come to FHC on odd days of the month will be included in the experimental group, and those who come on even days of the month will be included in the control group. Each group will be determined as 30 people. After the research is completed, the interventions applied to the experimental group will be applied to the women in the control group. Personal Information Form, Psychological Well-Being Scale and Incontinence Quality of Life Scale will be applied to women in the experimental and control groups as pre-test measurements. As a final test, the same measurements will be made to both the control group and the experimental group 16 weeks after the first measurement.
Read the detailed description
All applications regarding Kegel exercise and Ba Duan Jin applications have been determined. Kegel exercise content; At the beginning of the exercise, one should try to hold urine while emptying the bladder only once or twice in order to define the pelvic floor muscles correctly. If the result is successful, it means that the correct muscles contracted. The second stage, the beginning of the exercise; It can be performed in a supine position (with legs bent at the knee) or in a sitting position. The bladder should be emptied before starting exercise. In the determined position, the pelvic floor muscles should be contracted for 5 seconds, as if stopping urine or gas outflow, and then relaxed for 5 seconds. It should be repeated 4-5 times in a row. The gluteal, abdominal and thigh muscles should not contract. In this way, it is defined that the correct muscles are contracting. In the Ba Duan Jin practice: stretch the hands to the sky, pull the arrow and string the bow (the knees are bent, the sitting posture on the horse is taken, the hand and arm take a stance as if pulling an arrow to the right and left alternately, eyes look at the target in the distance), push the sky and the earth ( Similar to the first movement, while raising the hands, one hand is directed upwards towards the sky and the other hand is directed towards the ground, turn the head and look back, shake the head and shake the tail (This movement regulates the functions of the heart and lungs, facilitates relaxation by relaxing the sympathetic nervous system, and helps emotional imbalances in the body). It is said that it removes the stagnation of Qi and eliminates the numbness and malaise in the legs. Its main purpose is to eliminate excessive heat in the heart), bending the waist down and holding the feet, punching, looking angry and shaking the ground by heeling will be done respectively.
- Conditions
- Urinary Incontinence, Menopause, Wolman Disease, Quality of Life, Psychological Well-Being
- Being tested
- Training on Kegel exercise and Ba Duan Jin applications online, training on Kegel exercises and Ba Duan Jin applications after the research is completed
- Medical subject headings
- Urinary Incontinence, Wolman Disease, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training on Kegel exercise and Ba Duan Jin applications onlineBehavioural
Kegel exercises and Ba Duan Jin applications online
training on Kegel exercises and Ba Duan Jin applications after the research is completedBehavioural
Women in the control group will be given training on Kegel exercises and Ba Duan Jin applications after the research is completed.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Kegel exercises and Ba Duan Jin applications will be applied to women in the experimental group online (via Zoom application) in two sessions per week for a total of 8 weeks. Afterwards, women will be asked to perform these practices three days a week for 12 weeks and will be monitored. The research will last a total of 16 weeks. Receives: Behavioral: Training on Kegel exercise and Ba Duan Jin applications online |
| Control | Active comparator | Women in the control group will be given training on Kegel exercises and Ba Duan Jin applications after the research is completed. Receives: Behavioral: training on Kegel exercises and Ba Duan Jin applications after the research is completed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological Well-Being Scale
It was developed by Diener et al. to measure socio-psychological well-being as a complement to existing well-being measurements. The adaptation of the scale into Turkish was carried out by Telef. Factor loadings of the scale items were calculated between .54 and .76. The Cronbach's alpha internal consistency coefficient obtained in the reliability study of the scale was calculated as .80. All items are worded positively. Scores range from 8 to 56.
Measured: 4 month
Incontinence Quality of Life Scale
It was developed by Wagner et al. in 1996 in America to determine the quality of life of patients with urinary incontinence. However, the scale was revised by Patrick et al. in 1999, and during the creation of the European versions, six questions were removed and the number of questions was reduced to 22 by evaluating the psychometric measurements. In our country, the validity and reliability of I-QOL was determined by Özerdoğan. It is converted to a scale value up to 100. Higher scores indicate a better level of quality of life than lower scores.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birsen ALTAY, Ondokuz Mayıs University
- Investigators
- TUBA YILMAZ BULUT, Dr., Study chair, Kocaeli UniversityAynur ATAMAN KUFACI, Lecturer, Study chair, Sinop University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287658
- Sponsor's protocol ID
- E-57428665-050.04-240046
- Status last verified
- Apr 2024
- First submitted
- 19 Feb 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wagner TH, Patrick DL, Bavendam TG, Martin ML, Buesching DP. Quality of life of persons with urinary incontinence: development of a new measure. Urology. 1996 Jan;47(1):67-71; discussion 71-2. doi: 10.1016/s0090-4295(99)80384-7.
PubMed 8560665Telef BB. Psychological Well-Being Scale (PIOO): Adaptation to Turkish, Validity and Reliability Study. Hacettepe Faculty of Education Journal, 2013; 28(3):374-384
Diener E, Wirtz D, Tov W, Kim-Prieto C, Choi D, Oishi S, Biswas-Diener R. New well-being measures: Short scales to assess flourishing and positive and negative feelings. Social Indicators Research, 2010; 97: 143-156.
Özerdoğan N, Kızılkaya NB. Prevalence, risk factors, and impact on quality of life of urinary incontinence in women aged 20 and over in Eskişehir, Bilecik, Afyon, Kütahya provinces. Journal of Nursing 2003; 13:37-50.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kegel Exercise and Ba Duan Jin Applications on Quality of Life and Psychological Well-Being Applied to Premenopausal Women With Urinary Incontinence
- ClinicalTrials.gov ID
- NCT06287658
- Acronym / sponsor ID
- E-57428665-050.04-240046
- Conditions
- Urinary Incontinence, Menopause, Wolman Disease, Quality of Life, Psychological Well-Being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to determine the effects of Kegel exercise and Ba Duan Jin applications applied to premenopausal women with urinary incontinence on quality of life and psychological well-being. Study Group of the Research: Premenopausal women between the ages of 45-55 who come to the family health center with any complaint and have urinary incontinence. The research will be conducted as a randomized pre-test, post-test and control group intervention study design. The research will be conducted with women aged 45-55 with urinary incontinence who came for examination for any reason to a Family Health Center in Sinop between March 2024 and July 2024. According to the power analysis, the number of participants was calculated to be at least 54 when the type 1 error was taken as 0.05, the power was 0.95 and the effect size was medium (0.25) for the two-group design with two repeated measurements. To prevent possible data loss, the sample size was increased by 10% and the total number of participants was determined as 60. A total of 60 women, 30 experimental and 30 control, coming to the Family Health Center will be randomly included in the study. No information, Kegel exercise program and Ba Duan Jin applications will be given to the women in the experimental group, and no intervention will be given to the control group during the research process. Participants will be assigned to 2 groups: experimental and control. Those who come to FHC on odd days of the month will be included in the experimental group, and those who come on even days of the month will be included in the control group. Each group will be determined as 30 people. After the research is completed, the interventions applied to the experimental group will be applied to the women in the control group. Personal Information Form, Psychological Well-Being Scale and Incontinence Quality of Life Scale will be applied to women in the experimental and control groups as pre-test measurements. As a final test, the same measurements will be made to both the control group and the experimental group 16 weeks after the first measurement.
Detailed description
All applications regarding Kegel exercise and Ba Duan Jin applications have been determined. Kegel exercise content; At the beginning of the exercise, one should try to hold urine while emptying the bladder only once or twice in order to define the pelvic floor muscles correctly. If the result is successful, it means that the correct muscles contracted. The second stage, the beginning of the exercise; It can be performed in a supine position (with legs bent at the knee) or in a sitting position. The bladder should be emptied before starting exercise. In the determined position, the pelvic floor muscles should be contracted for 5 seconds, as if stopping urine or gas outflow, and then relaxed for 5 seconds. It should be repeated 4-5 times in a row. The gluteal, abdominal and thigh muscles should not contract. In this way, it is defined that the correct muscles are contracting. In the Ba Duan Jin practice: stretch the hands to the sky, pull the arrow and string the bow (the knees are bent, the sitting posture on the horse is taken, the hand and arm take a stance as if pulling an arrow to the right and left alternately, eyes look at the target in the distance), push the sky and the earth ( Similar to the first movement, while raising the hands, one hand is directed upwards towards the sky and the other hand is directed towards the ground, turn the head and look back, shake the head and shake the tail (This movement regulates the functions of the heart and lungs, facilitates relaxation by relaxing the sympathetic nervous system, and helps emotional imbalances in the body). It is said that it removes the stagnation of Qi and eliminates the numbness and malaise in the legs. Its main purpose is to eliminate excessive heat in the heart), bending the waist down and holding the feet, punching, looking angry and shaking the ground by heeling will be done respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Training on Kegel exercise and Ba Duan Jin applications onlineKegel exercises and Ba Duan Jin applications will be applied to women in the experimental group online (via Zoom application) in two sessions per week for a total of 8 weeks. Afterwards, women will be asked to perform these practices three days a week for 12 weeks and will be monitored. The research will last a total of 16 weeks. |
| Control | Active comparator | Behavioral: training on Kegel exercises and Ba Duan Jin applications after the research is completedWomen in the control group will be given training on Kegel exercises and Ba Duan Jin applications after the research is completed. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Agreeing to participate in the study
- Having a complaint of urinary incontinence
- Being a woman between the ages of 45-55
- Being communicable
- Having a device (phone, tablet, computer) that can participate in online conversations
Key exclusion criteria (3 listed)
- Women who do not complain of urinary incontinence
- Women in menopause
- Women who left unanswered questions on their scale forms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training on Kegel exercise and Ba Duan Jin applications onlineKegel exercises and Ba Duan Jin applications online | Behavioural | Experimental |
| training on Kegel exercises and Ba Duan Jin applications after the research is completedWomen in the control group will be given training on Kegel exercises and Ba Duan Jin applications after the research is completed. | Behavioural | Control |
Primary outcome
Psychological Well-Being Scale
Time frame: 4 month
It was developed by Diener et al. to measure socio-psychological well-being as a complement to existing well-being measurements. The adaptation of the scale into Turkish was carried out by Telef. Factor loadings of the scale items were calculated between .54 and .76. The Cronbach's alpha internal consistency coefficient obtained in the reliability study of the scale was calculated as .80. All items are worded positively. Scores range from 8 to 56.
Incontinence Quality of Life Scale
Time frame: 4 month
It was developed by Wagner et al. in 1996 in America to determine the quality of life of patients with urinary incontinence. However, the scale was revised by Patrick et al. in 1999, and during the creation of the European versions, six questions were removed and the number of questions was reduced to 22 by evaluating the psychometric measurements. In our country, the validity and reliability of I-QOL was determined by Özerdoğan. It is converted to a scale value up to 100. Higher scores indicate a better level of quality of life than lower scores.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Background: PubMed 8560665Wagner TH, Patrick DL, Bavendam TG, Martin ML, Buesching DP. Quality of life of persons with urinary incontinence: development of a new measure. Urology. 1996 Jan;47(1):67-71; discussion 71-2. doi: 10.1016/s0090-4295(99)80384-7.
- BackgroundTelef BB. Psychological Well-Being Scale (PIOO): Adaptation to Turkish, Validity and Reliability Study. Hacettepe Faculty of Education Journal, 2013; 28(3):374-384
- BackgroundDiener E, Wirtz D, Tov W, Kim-Prieto C, Choi D, Oishi S, Biswas-Diener R. New well-being measures: Short scales to assess flourishing and positive and negative feelings. Social Indicators Research, 2010; 97: 143-156.
- BackgroundÖzerdoğan N, Kızılkaya NB. Prevalence, risk factors, and impact on quality of life of urinary incontinence in women aged 20 and over in Eskişehir, Bilecik, Afyon, Kütahya provinces. Journal of Nursing 2003; 13:37-50.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
TUBA YILMAZ BULUT, Dr. study chair
Kocaeli University
Aynur ATAMAN KUFACI, Lecturer study chair
Sinop University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training on Kegel exercise and Ba Duan Jin applications online and training on Kegel exercises and Ba Duan Jin applications after the research is completed in people with Urinary Incontinence and Menopause, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Birsen ALTAY, Ass. Prof. (0 (535) 546 54 53, baltay@omu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Well-Being Scale (time frame: 4 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06287658, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.