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

Primary Purpose

Multiple Sclerosis, Reflexology, Urinary Incontinence

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reflexology and kegel exercises
Sponsored by
Ondokuz Mayıs University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Multiple sclerosis, Nurses, Complementary Therapies, Urinary Incontinence, Reflexology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Afitap ÖZDELİKARARecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Median score distributions of the reflexology groups, ICIQ-SF, IQOL and ISI

Median score distributions of the kegel groups, ICIQ-SF, IQOL and ISI

Median score distributions of the control groups, ICIQ-SF, IQOL and ISI

Arm Description

Outcomes

Primary Outcome Measures

Index of severity incontinence (ISI)
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.
nternational Consultation on Incontinence Questionnaire Short Form(ICIQ-SF)
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.
Incontinence quality of life (IQOL)
The total score ranges from 0 to 100. High scores indicate better quality of life than low scores.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2022
Last Updated
September 13, 2022
Sponsor
Ondokuz Mayıs University
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1. Study Identification

Unique Protocol Identification Number
NCT05541965
Brief Title
The Effect of Reflexology and Pelvic Floor Muscle Exercises (Kegel) on Urinary Incontinence in MS Patients
Official Title
The Effect of Reflexology and Pelvic Floor Muscle Exercises (Kegel) on Urinary Incontinence in MS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ondokuz Mayıs University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Reflexology, Urinary Incontinence
Keywords
Multiple sclerosis, Nurses, Complementary Therapies, Urinary Incontinence, Reflexology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Median score distributions of the reflexology groups, ICIQ-SF, IQOL and ISI
Arm Type
Experimental
Arm Title
Median score distributions of the kegel groups, ICIQ-SF, IQOL and ISI
Arm Type
Active Comparator
Arm Title
Median score distributions of the control groups, ICIQ-SF, IQOL and ISI
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Reflexology and kegel exercises
Intervention Description
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 Measure Information:
Title
Index of severity incontinence (ISI)
Description
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.
Time Frame
4 weeks
Title
nternational Consultation on Incontinence Questionnaire Short Form(ICIQ-SF)
Description
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.
Time Frame
4 weeks
Title
Incontinence quality of life (IQOL)
Description
The total score ranges from 0 to 100. High scores indicate better quality of life than low scores.
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Afitap ÖZDELİKARA
City
Samsun
ZIP/Postal Code
55200
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afitap ÖZDELİKARA
Phone
+905054560363
Email
afitapozdelikara@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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