]>
IRCT20210612051553N1 IRCT 2023-09-12 Bojnourd University of Medical Sciences ٍEffect of modified foot reflexology massage on the intensity of peripheral neuropathy Evaluation of the effect of modified foot reflexology massage on the intensity of peripheral neuropathy in the elderly with type 2 diabetes induced neuropathy 2023-09-23 anticipated 60 Complete https://irct.ir/trial/56861 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, a purposive sampling will be done; then eligible subjects will be randomly allocated into two groups, using permutation blocks randomization approach and the codes generated by the relevant software. Subjects will be randomized individually, Blinding description: After selecting and entering the eligible elderly to study, they will be informed that they will receive one of the two types of massage in this study. But the elderly will not be informed about how people are placed in the groups until the end of the study. N/A Peripheral neuropathy in the elderly with type 2 diabetes. Intervention 1: Intervention group: The members of the intervention group will be trained in modified foot reflexology massage in such a way that the caregiver, after performing the preparation techniques, massages the points in the legs related to the pancreas, liver, kidney and stomach. The intervention protocol is 10 minutes each time (for each leg, which includes 2 minutes of preparation and 8 minutes of massaging the defined points) during the first 30 days. Intervention 2: Control group: The members of the control group are given false foot massage training in such a way that the caregiver, after performing the preparation techniques, massages the points on the legs related to the pancreas, liver, kidneys and stomach by touching the skin of the feet without pressure. The intervention protocol, during the first 30 days, is 10 minutes each time (for each leg, which includes 2 minutes of preparation and 8 minutes of massaging the defined points). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Fatemeh Bakzadeh
Bojnurd School of Nursing and Midwifery, Shahriar St.
Bojnurd Iran (Islamic Republic of) 9414974877 +98 58 4724 2185 fatimabakzadeh@gmail.com Bojnourd University of Medical Sciences scientific Dr. Mohammad Reza Armat
Bojnurd School of Nursing and Midwifery, Shahriar St.
Bojnurd Iran (Islamic Republic of) 9414974877 +98 58 3229 7097 armat@nkums.ac.ir Bojnourd University of Medical Sciences Iran (Islamic Republic of) Being 60 years old and over Having a health record in the health center (Includes demographic information and medical records) Having diabetic neuropathy diagnosed by a physician Having a knowledgeable and trainable caregiver Passing at least one week since the start of insulin treatment 60 years no limit Both Having orthopedic, rheumatological, vascular disorders, disorders of the nervous and mental system affecting neuropathy (such as deep vein thrombosis, varicose veins, gout, diagnosis of stroke, multiple sclerosis, Parkinson's, spinal cord injury, and Guillen are diagnosed) based on physician's approval Having a wound and amputation in the leg Receiving any message before study initiation Being on medications effective on sympathetic system E11.4 Type 2 diabetes mellitus with neurological complications Treatment - Other Treatment - Other Intervention group: The members of the intervention group will be trained in modified foot reflexology massage in such a way that the caregiver, after performing the preparation techniques, massages the points in the legs related to the pancreas, liver, kidney and stomach. The intervention protocol is 10 minutes each time (for each leg, which includes 2 minutes of preparation and 8 minutes of massaging the defined points) during the first 30 days. Control group: The members of the control group are given false foot massage training in such a way that the caregiver, after performing the preparation techniques, massages the points on the legs related to the pancreas, liver, kidneys and stomach by touching the skin of the feet without pressure. The intervention protocol, during the first 30 days, is 10 minutes each time (for each leg, which includes 2 minutes of preparation and 8 minutes of massaging the defined points). Intensity of peripheral neuropathy based on the Michigan instrument. Timepoint: Study onset (day 0) , days 10, 20, 30 and 40 (Ten days after the end of the intervention). Method of measurement: Michigan Instrument. Bojnourd University of Medical Sciences Approved 2022-01-10 Ethics committee of North Khorasan University of Medical Sciences Central Building of North Khorasan University of Medical Sciences, Dolat Blvd, Bojnurd Bojnurd North Khorasan Iran (Islamic Republic of)