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IRCT20180103038211N5 IRCT 2018-10-20 Arak University of Medical Sciences The effect of reflexology on constipation The effect of foot reflexology on constipation in patients with MS 2018-05-22 anticipated 54 Complete https://irct.ir/trial/31363 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Study population consists of patients who were registered in the MS center. Subjects were invited in the study with invitation letter. The Subjects with entry criteria were selected by simple sampling methods. Each person was given a number from 1 to n and then were assigned with using random numbers randomly to either an experimental or a control group, Blinding description: Individuals with entry criteria are divided into intervention and control groups according to the random numbers table. One of the groups is A and the other is called B. Before and after the intervention, the information is collected by the evaluator of the outcome that is unaware of the Classification of the groups. Data analysis is also done by someone who is unaware of the allocation of groups. The control group also receive similar (but not effective) intervention so are unaware of the allocation to the intervention or control group. N/A Multiple sclerosis. Intervention 1: Intervention group: The study group receives 12 reflexology sessions for 30 minutes, twice a week for 6 weeks. Reflexology massage time is for 15 minutes, for each leg and includes general massage of the feet, and then massage the points related to the digestive tract (stomach, liver, small intestine and large) and affecting constipation. The reflexology is taught to the patient's caregiver and the accuracy of reflexology is ensured. Then reflexology is performed by the patient's caregiver at home for this period. We communicate with patients and follows through telephone and SMS. Intervention 2: Control group: Patients do not receive any reflexology intervention from the researcher. To unify the interventions, patient's caregiver touches the patient's foot surface for 30 minutes, twice a week for 6 weeks and also this patientes takes routine constipation treatment by the doctor. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Fahimeh Davodabady
Arak University of Medical Sciences, Basij Square, Sardasht
Arak Iran (Islamic Republic of) 6941-7-38481 +98 86 3417 3503 fahimedavodabady@gmail.com Arak University of Medical Sciences scientific Fahimeh Davodabady
Arak University of Medical Sciences, Basij Square, Sardasht
Arak Iran (Islamic Republic of) 6941-7-38481 +98 86 3417 3503 Fahimedavodabady@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) All patients with MS who have Expanded Disability Status Scale (EDSS) equal or less than 4. Patients with MS aged 18 to 50 years old Informed consent 18 years 50 years Both Use of other complementary and alternative methods during the study History of Hypothyroidism, hyperparathyroidism, hypopituitarism declared by the patient Sleeping and sedative medications, antidepressants and analgesics during the study Having problems with the legs, including problems with blood flow (confirmed by the cardiologist) The presence of burn, fungal infection, varicose veins, warts, corns and any kind of numbness in the leg The presence of deformity or ulcer in the area of massage on the plantar area Irritable bowel syndrome confirmed by a doctor Gastrointestinal obstructive diseases, inflammatory digestive diseases G35-G37 Demyelinating diseases of the central nervous system Treatment - Other Treatment - Other Intervention group: The study group receives 12 reflexology sessions for 30 minutes, twice a week for 6 weeks. Reflexology massage time is for 15 minutes, for each leg and includes general massage of the feet, and then massage the points related to the digestive tract (stomach, liver, small intestine and large) and affecting constipation. The reflexology is taught to the patient's caregiver and the accuracy of reflexology is ensured. Then reflexology is performed by the patient's caregiver at home for this period. We communicate with patients and follows through telephone and SMS. Control group: Patients do not receive any reflexology intervention from the researcher. To unify the interventions, patient's caregiver touches the patient's foot surface for 30 minutes, twice a week for 6 weeks and also this patientes takes routine constipation treatment by the doctor. Constipation. Timepoint: At the beginning of the study and at the end of the sixth week after the intervention began. Method of measurement: Constipation Assessment Scale (CAS). Quality of Life. Timepoint: At the beginning of the study and at the end of the sixth week after the intervention began. Method of measurement: Quality of life SF36 questionnaire. Arak University of Medical Sciences Approved 2018-05-06 Ethics committee of Arak University of Medical Sciences Arak University of Medical Sciences, Basij Square, Sardasht Arak Markazi Iran (Islamic Republic of)