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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05541965
Other study ID # Reflexology55
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2020
Est. completion date September 30, 2022

Study information

Verified date September 2022
Source Ondokuz Mayis University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Other:
Reflexology and kegel exercises
Reflexology is specific to a foot massage, and it can use different symptoms for patients. Kegel exercise is specific an activities and it can used for urinary incontinence

Locations

Country Name City State
Turkey Afitap ÖZDELIKARA Samsun

Sponsors (1)

Lead Sponsor Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Primary 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. 4 weeks
Primary Incontinence quality of life (IQOL) The total score ranges from 0 to 100. High scores indicate better quality of life than low scores. 4 weeks
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