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

NCT06287658 | Recruiting

• 1 other identifier: E-57428665-050.04-240046
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  4 month

Study Arms (2)

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.

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.

Behavioral: 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 BEHAVIORAL

Kegel exercises and Ba Duan Jin applications online

Experimental

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

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

Control

Eligibility Criteria

• Age: 45 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Tuba Yilmaz Bulut

Kocaeli, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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.

  PMID: 8560665 BACKGROUND

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

  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.

  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.

  BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence; Wolman Disease; Psychological Well-Being

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cholesterol Ester Storage Disease; Lipidoses; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lysosomal Storage Diseases; Infant, Newborn, Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Personal Satisfaction; Behavior

Study Officials

• TUBA YILMAZ BULUT, Dr.

  Kocaeli University

  STUDY CHAIR

• Aynur ATAMAN KUFACI, Lecturer

  Sinop University

  STUDY CHAIR

Central Study Contacts

Birsen ALTAY, Ass. Prof.

CONTACT

0 (535) 546 54 53; baltay@omu.edu.tr

Tuba YILMAZ BULUT, Dr.

CONTACT

+905343435109; tuba_yilmaz1991@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 1, 2024
• Study Start: April 1, 2024
• Primary Completion: July 1, 2024
• Study Completion: March 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

TU (1)