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The Effect of Reflexology and Pelvic Floor Muscle Exercises (Kegel) on Urinary Incontinence in MS Patients

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ClinicalTrials.gov Identifier: NCT05541965
Recruitment Status : Recruiting
First Posted : September 15, 2022
Last Update Posted : September 15, 2022
Sponsor:
Information provided by (Responsible Party):
Afitap Ozdelikara, Ondokuz Mayıs University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Reflexology Urinary Incontinence Other: Reflexology and kegel exercises Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: The Effect of Reflexology and Pelvic Floor Muscle Exercises (Kegel) on Urinary Incontinence in MS Patients
Actual Study Start Date : May 1, 2020
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Median score distributions of the reflexology groups, ICIQ-SF, IQOL and ISI Other: Reflexology and kegel exercises

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 kegel groups, ICIQ-SF, IQOL and ISI Other: Reflexology and kegel exercises

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 Other: Reflexology and kegel exercises

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





Primary Outcome Measures :
  1. 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.

  2. nternational Consultation on Incontinence Questionnaire Short Form(ICIQ-SF) [ Time Frame: 4 weeks ]
    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.

  3. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05541965


Locations
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Turkey
Afitap ÖZDELİKARA Recruiting
Samsun, Turkey, 55200
Contact: Afitap ÖZDELİKARA    +905054560363    afitapozdelikara@gmail.com   
Sponsors and Collaborators
Ondokuz Mayıs University
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Responsible Party: Afitap Ozdelikara, Associate Proffesor, Ondokuz Mayıs University
ClinicalTrials.gov Identifier: NCT05541965    
Other Study ID Numbers: Reflexology55
First Posted: September 15, 2022    Key Record Dates
Last Update Posted: September 15, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Afitap Ozdelikara, Ondokuz Mayıs University:
Multiple sclerosis
Nurses
Complementary Therapies
Urinary Incontinence
Reflexology
Additional relevant MeSH terms:
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Multiple Sclerosis
Urinary Incontinence
Enuresis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders