- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05541965
The Effect of Reflexology and Pelvic Floor Muscle Exercises (Kegel) on Urinary Incontinence in MS Patients
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The research was carried out as experiment, control group, pretest-posttest model and single-blind. The population of the study consisted of MS patients who applied to OMU (Ondokuz Mayıs University) Neurology Service and Neurology Outpatient Clinic between March 2020 and February 2022. Fifteen patients who met the inclusion criteria were included in the study. Patients were divided into reflexology, pelvic floor muscle exercise and control groups. The control group was not intervened, only data collection tools were applied.
reflexology intervention The reflexology application was carried out in a separate and quiet room, on a stretcher/bed where the patient could lie down, by adjusting the temperature so that they would not feel cold/sweaty. First, the feet were cleaned with a warm, damp cotton towel. Odorless, room temperature baby oil was used to provide lubricity during the reflexology application. The reflexology protocol was started with the right foot. First of all, rotation, vibration, etc. are applied to the ankle and ankle areas. relaxation techniques were applied for 2 minutes. Afterwards, reflexology massage was applied to the spinal cord, brain, pituitary areas, kidney, ureter and bladder areas with appropriate techniques. The session was concluded with solar plexus compression and relaxation maneuvers. The same protocol was applied in the left foot. Immediately after each reflexology session, the patient was allowed to drink 1 glass (200 ml) of water to accelerate the excretion of toxic products. Reflexology session was completed in 40 minutes for both feet. Foot reflexology was applied to the reflexology group twice a week (40 minutes for both feet) for a total of 4 weeks.
Pelvic floor muscle exercise (Kegel) application In the Kegel exercise group, the patients were taught the Kegel exercise at the first interview, and it was provided to be done under the guidance of the researcher. Afterward, they were asked to apply at least three times a day for four weeks, and a reminder SMS was sent to the patients daily.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Samsun, Turkey, 55200
- Afitap ÖZDELİKARA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with MS at least 6 months ago,
- Having an EDSS of <5,
Exclusion Criteria:
- To have wound on foots, varicose veins, etc. history of fractures causing loss of function, nail fungus,
- pregnancy,
- presence of acute infection
- To using any diuretic or incontinence medication,
- To have a curettage or pregnancy history in the last 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Median score distributions of the reflexology groups, ICIQ-SF, IQOL and ISI
|
Reflexology is specific to a foot massage, and ıt can use different symptoms for patients. Kegel exercise is specific an activities and ıt can used for urinary incontinence |
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Active Comparator: Median score distributions of the kegel groups, ICIQ-SF, IQOL and ISI
|
Reflexology is specific to a foot massage, and ıt can use different symptoms for patients. Kegel exercise is specific an activities and ıt can used for urinary incontinence |
|
Active Comparator: Median score distributions of the control groups, ICIQ-SF, IQOL and ISI
|
Reflexology is specific to a foot massage, and ıt can use different symptoms for patients. Kegel exercise is specific an activities and ıt can used for urinary incontinence |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Index of severity incontinence (ISI)
Time Frame: 4 weeks
|
The total score is between 0-12.
A score of "0" indicates that there is no incontinence.
The scale score is then categorized into 4 different levels of incontinence severity: 1-2: mild, 3-6: moderate, 8-9: severe, 10-12: very serious.
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4 weeks
|
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nternational Consultation on Incontinence Questionnaire Short Form(ICIQ-SF)
Time Frame: 4 weeks
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The scores that can be obtained from the scale range from 0 to 21; A low score indicates that urinary incontinence has little effect on quality of life, while a high score indicates that it affects the quality of life very much.
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4 weeks
|
|
Incontinence quality of life (IQOL)
Time Frame: 4 weeks
|
The total score ranges from 0 to 100.
High scores indicate better quality of life than low scores.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Nervous System Diseases
- Mental Disorders
- Pathologic Processes
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Autoimmune Diseases
- Immune System Diseases
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Behavioral Symptoms
- Elimination Disorders
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Urinary Incontinence
- Enuresis
- Multiple Sclerosis
- Sclerosis
Other Study ID Numbers
- Reflexology55
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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