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

April 1, 2024 updated by: Birsen ALTAY, Ondokuz Mayıs University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Birsen ALTAY, Ass. Prof.
  • Phone Number: 0 (535) 546 54 53
  • Email: baltay@omu.edu.tr

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Kegel exercises and Ba Duan Jin applications online
Active Comparator: Control
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
Women in the control group will be given training on Kegel exercises and Ba Duan Jin applications after the research is completed.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 month
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.
4 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ondokuz Mayıs University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: TUBA YILMAZ BULUT, Dr., Kocaeli University
  • Study Chair: Aynur ATAMAN KUFACI, Lecturer, Sinop University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E-57428665-050.04-240046

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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