The Effect of Kegel Exercise and Ba Duan Jin Applications on Premenopausal Women With Urinary Incontinence

NCT ID: NCT06287658

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-03-01

Brief 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. 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.

Conditions

Urinary Incontinence; Menopause; Wolman Disease; Quality of Life; Psychological Well-Being

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Training on Kegel exercise and Ba Duan Jin applications online

Intervention Type: BEHAVIORAL

Kegel exercises and Ba Duan Jin applications online

Control

Women in the control group will be given training on Kegel exercises and Ba Duan Jin applications after the research is completed.

Group Type: ACTIVE_COMPARATOR

training on Kegel exercises and Ba Duan Jin applications after the research is completed

Intervention Type: BEHAVIORAL

Women in the control group will be given training on Kegel exercises and Ba Duan Jin applications after the research is completed.

Interventions

Training on Kegel exercise and Ba Duan Jin applications online

Kegel exercises and Ba Duan Jin applications online

Intervention Type: BEHAVIORAL

training on Kegel exercises and Ba Duan Jin applications after the research is completed

Women in the control group will be given training on Kegel exercises and Ba Duan Jin applications after the research is completed.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Women who do not complain of urinary incontinence
• Women in menopause
• Women who left unanswered questions on their scale forms

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

Birsen ALTAY

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

TUBA YILMAZ BULUT, Dr.

Role: STUDY_CHAIR

Kocaeli University

Aynur ATAMAN KUFACI, Lecturer

Role: STUDY_CHAIR

Sinop University

Locations

Tuba Yilmaz Bulut

Kocaeli, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Birsen ALTAY, Ass. Prof.

Role: CONTACT

baltay@omu.edu.tr

0 (535) 546 54 53

Tuba YILMAZ BULUT, Dr.

Role: CONTACT

tuba_yilmaz1991@hotmail.com

+905343435109

Facility Contacts

TUBA YILMAZ BULUT, Dr.

Role: primary

tuba_yilmaz1991@hotmail.com

05343435109

References

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.

Reference Type: BACKGROUND

PMID: 8560665 (View on PubMed)

Telef BB. Psychological Well-Being Scale (PIOO): Adaptation to Turkish, Validity and Reliability Study. Hacettepe Faculty of Education Journal, 2013; 28(3):374-384

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

Other Identifiers

E-57428665-050.04-240046

Identifier Type: -

Identifier Source: org_study_id