360 Degree Expanded Diaphragm Breathing Pattern Training in Individuals With Urinary Incontinence

Sponsor
Uskudar University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06003894
Collaborator
(none)
66
1
2
2.8
23.4

Study Details

Study Description

Brief Summary

The aim of this study is to investigate the effect of transferring the healthy intra-abdominal pressure created by 360 degree expanded diaphragm breathing taught to the patient to the pelvic cavity on incontinence problems.

Condition or Disease Intervention/Treatment Phase
  • Other: kegel exercises
  • Other: 360 degree expanded diaphragmatic breathing training
N/A

Detailed Description

66 people with a score of 3 or higher on the Incontinence Severity Index will be included in the study. All participants will complete the King Health Questionnaire and Incontinence Quality of Life Questionnaires. The control group will consist of 33 people and will apply only Kegel exercises 2 sets a day, 3 days a week for 8 weeks. The experimental group will consist of 33 people and the participants will apply Kegel exercises for 8 weeks, 3 days a week, 2 sets a day. In addition to this, 360 degree expanded diaphragm breathing training will be given to the experimental group. Practices for using this breathing pattern will be done 2 sets per day, each set for 10 minutes. At the end of 8 weeks, all 3 questionnaires will be asked to be filled again. The variation between the initial results and the final results, as well as the differences between the final changes, will also be compared.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
66 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
360 degree expanded diaphragm breathing360 degree expanded diaphragm breathing
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of the Effectiveness of Kegel Exercises and 360-degree Expanded Diaphragm Breathing Pattern Training in Individuals With Urinary Incontinence
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Nov 20, 2023
Anticipated Study Completion Date :
Dec 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: kegel group

Participants will only practice kegel exercises.

Other: kegel exercises
Kegel exercises; It is done by squeezing your pelvic floor muscles for 3 to 5 seconds and relaxing them. Participants are expected to do this exercise in the form of hold-relax 10-15 times each set. Participants are expected to practice Kegel exercises, 2 sets a day, 3 days a week for 8 weeks.

Experimental: diaphragm group

In addition to kegel exercises, 360 degree expanded diaphragm breathing training will be given to the participants.

Other: kegel exercises
Kegel exercises; It is done by squeezing your pelvic floor muscles for 3 to 5 seconds and relaxing them. Participants are expected to do this exercise in the form of hold-relax 10-15 times each set. Participants are expected to practice Kegel exercises, 2 sets a day, 3 days a week for 8 weeks.

Other: 360 degree expanded diaphragmatic breathing training
360-degree expanded diaphragm breathing is the delivery of air taken during inspiration to the postero-lateral wall of the abdomen. Breathing in this way ensures that the pressure in the abdomen is distributed equally in all directions. Practices for using this breathing pattern will be done 2 sets per day, each set for 10 minutes.

Outcome Measures

Primary Outcome Measures

  1. The incontinence severity index (ISI) [10 weeks]

    It was developed in epidemiological and clinical studies to identify women with urinary incontinence of varying severity. The questionnaire score is obtained by multiplying the value given to the frequency of urinary incontinence by the value given to the amount of urinary incontinence. The result obtained; classified as mild, moderate, severe, very severe.

  2. Understanding King's Health Questionnaire (KHQ) [10 weeks]

    The King's Health questionnaire is a two-part questionnaire that includes 32 items and is frequently used to evaluate the quality of life of patients with incontinence. It includes 7 sub-headings consisting of multiple items in addition to two single-item questions such as general health status and impact on quality of life. These include: role limitations, physical limitations, social limitations, limitations in personal relationships, emotional problems, sleep and energy disturbances associated with incontinence, and severity measures for incontinence. The second part is the 11-item Symptom Severity Scale, which assesses the presence and severity of urinary symptoms. The score of the Symptom Severity Scale ranges from 0 (best) to 30 (worst). For other areas, scores range from 0 (best) to -100 (worst).

  3. Incontinence Quality of Life Questionnaire (I-QOL) [10 weeks]

    In the Incontinence Quality of Life Scale (I-QOL), which consists of 22 items, all items are evaluated on a five-category Likert-type scale (1= a lot, 2= a lot, 3= moderately, 4= a little, 5= not at all). The scores of the questionnaire and its subscales are obtained by adding the scores of each item and dividing this total by the number of items. For easier explanation of the scores, the calculated total score is converted to a scale value from 0 (lowest quality of life) to 100 (highest quality of life). High scores indicate better quality of life than low scores.

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Getting a score of 3 and above in the incontinence severity index.

  • Be in the age range of 12-65 years.

  • No neurological problems.

Exclusion Criteria:

• Having a history of surgery or childbirth in the last 3 months.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Üsküdar Unıversıty Üsküdar İstanbul Turkey

Sponsors and Collaborators

  • Uskudar University

Investigators

  • Study Chair: Elif AKAR, Uskudar University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dr. Öğr. Üyesi Ömer Şevgin, Asst. Prof. Dr., Uskudar University
ClinicalTrials.gov Identifier:
NCT06003894
Other Study ID Numbers:
  • Uskudar64
First Posted:
Aug 22, 2023
Last Update Posted:
Aug 22, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Öğr. Üyesi Ömer Şevgin, Asst. Prof. Dr., Uskudar University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2023