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IRCT20230225057526N1 IRCT 2023-02-28 Kashan University of Medical Sciences The Effect of Foot Reflexology on Severity of Frailty and Quality of Sleep in Frail Older Adults The Effect of Foot Reflexology on Severity of Frailty and Quality of Sleep in Frail Older Adults 2023-03-01 anticipated 60 Complete https://irct.ir/trial/68804 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization will be done in a simple way. Random Number Generator software version 1.4 will be used to randomize and divide groups. In this software, the smallest and largest number and the required number of random numbers are determined. The numbers obtained in the first group will be assigned for the control group and the same numbers group will be assigned for the intervention group. N/A Frail Older Adults. Intervention 1: Intervention group: The participants of the Intervention group in the first session receive general information about foot reflexology, the history of this method and its benefits, and their possible questions are answered. Then, the initial questionnaires will be completed for them, and the technique implementation guide, intervention meeting schedule sheet, and communication methods will be provided to the participants. The test group receives foot reflexology massage by the researcher once a week for two months. The time of each session will be 30 minutes. The intervention will be done for each person on a certain day of the week done in a bright and quiet room at the health center. If the person is not able to go to the health center, the researcher goes to their house and tries to do the intervention in a quiet and comfortable room. To implement the intervention, the participant is placed on the bed in a relaxed position, then the researcher sits at the bottom of the bed and rubs the surfaces of his palms together to become warm. Then the back and soles of the feet will be massaged. In order to carry out the intervention, the researcher hold the heel with his left hand and pointed with the thumb and forefinger of his right hand on the corresponding reflex points (solar plexus, pituitary gland, eye, ear, brain, spine, sciatic nerve, heart, thyroid, hip joint). (although there is no clear information about the reflex points, these points were chosen based on past studies and their effectiveness) this work for 30 minutes on both legs (15 minutes for each leg) ) is done. The researcher, at the first 5 minutes, will perform a gentle massage of the soles of the feet and each reflex point will receive a minute of proper pressure. If the elderly person does not participate for the massage at the appointed time, the compensatory session will be held at the earliest possible time, and the rest of the sessions will be carried out according to the previous schedule, and all the elderly must receive 8 intervention sessions. Intervention 2: Control group: for the control group, common programs of comprehensive health service centers done for the older adults. The common programs of these centers include screening in the electronic health system (SEB). In this system, the older adults are routinely screened for high blood pressure, nutrition, depression, falls and imbalance, heart and brain strokes, colon cancer and vaccination. In the screenings, the needs of the elderly are determined and based on that, they are trained and referred to the doctor. One week after the last intervention session (because no intervention is done in the control group, eight weeks after filling out the initial questionnaire), questionnaires will be completed for them again. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts from 1402 and the access period starts 2 months after the results are printed To whom: All people are allowed to send requests to receive data or other study documents. Conditions: There are no properties available. Where to obtain: Salman Rahnma's email address is slmanrhnma@gmail.com How to obtain: A week Comments:
public Salman Rahnama
Plate 131. In front of 12th Imami School.Martyrs' field Jami St
Esfahan Iran (Islamic Republic of) 8137777591 +98 31 3339 3844 slmanrhnma@gmail.com Kashan University of Medical Sciences scientific Salman Rahnama
plate 131. in front of 12 Imami school,Martyrs' field Jami St.
Esfshsn Iran (Islamic Republic of) 8137777591 +98 31 3339 3844 slmanrhnma@gmail.com Kashan University of Medical Sciences Iran (Islamic Republic of) 1. Patients must be at least 60 years old. 2. Patients with Frailty conditions who score at least 3 from Farid's questionnaire 3. Patients who do not have a history of foot reflexology or foot massage. 4. Be free of any wounds on the legs (no deformity, calluses or corns, fissures, active thrombosis or phlebitis, varicose veins, recent ankle trauma, sprains, fractures, inflammation or infection). 5.No abnormal symptoms such as sensitivity to pain under the pressure of the intervening finger, a clear change in skin color (for example, reddish brown/brown/dark brown/black), swelling (meaning creating a convex shape), hollowing ( creating a concave shape), hollows using specific finger pressure should be seen in the legs. 6.Be able to communicate vigilantly and verbally in Persian. 7. Tend to participate in the study Willingly. 8. Not suffering from dementia or getting a score higher than 22 from the M.M.S.E questionnaire. 9. Not having diabetes. 10. Not using Opiates. 60 years no limit Both Hospitalization of the Older Adult Use other complementary treatments. Z00.0 Encounter for general adult medical examination Rehabilitation N/A Intervention group: The participants of the Intervention group in the first session receive general information about foot reflexology, the history of this method and its benefits, and their possible questions are answered. Then, the initial questionnaires will be completed for them, and the technique implementation guide, intervention meeting schedule sheet, and communication methods will be provided to the participants. The test group receives foot reflexology massage by the researcher once a week for two months. The time of each session will be 30 minutes. The intervention will be done for each person on a certain day of the week done in a bright and quiet room at the health center. If the person is not able to go to the health center, the researcher goes to their house and tries to do the intervention in a quiet and comfortable room. To implement the intervention, the participant is placed on the bed in a relaxed position, then the researcher sits at the bottom of the bed and rubs the surfaces of his palms together to become warm. Then the back and soles of the feet will be massaged. In order to carry out the intervention, the researcher hold the heel with his left hand and pointed with the thumb and forefinger of his right hand on the corresponding reflex points (solar plexus, pituitary gland, eye, ear, brain, spine, sciatic nerve, heart, thyroid, hip joint). (although there is no clear information about the reflex points, these points were chosen based on past studies and their effectiveness) this work for 30 minutes on both legs (15 minutes for each leg) ) is done. The researcher, at the first 5 minutes, will perform a gentle massage of the soles of the feet and each reflex point will receive a minute of proper pressure. If the elderly person does not participate for the massage at the appointed time, the compensatory session will be held at the earliest possible time, and the rest of the sessions will be carried out according to the previous schedule, and all the elderly must receive 8 intervention sessions. Control group: for the control group, common programs of comprehensive health service centers done for the older adults. The common programs of these centers include screening in the electronic health system (SEB). In this system, the older adults are routinely screened for high blood pressure, nutrition, depression, falls and imbalance, heart and brain strokes, colon cancer and vaccination. In the screenings, the needs of the elderly are determined and based on that, they are trained and referred to the doctor. One week after the last intervention session (because no intervention is done in the control group, eight weeks after filling out the initial questionnaire), questionnaires will be completed for them again. Frailty score from Farid questionnaire. Timepoint: Measuring of frailty at the beginning of the study and re-msuring of frailty one week after the intervention. The intervention will be carried out for eight weeks. The questionnaire will be completed in the first week and the 9th week. Method of measurement: Frailty will be measured by a 5-item Farid questionnaire(FSC=Frailty Syndrome Checklist 5-Items). No Frailty (score 0), pre-Frailty (score 1-2) and Frailty (score 3-5). Sleep quality score from Pittsburgh questionnaire. Timepoint: Measurement of sleep quality at the beginning of the study and re-measurement one week after the intervention. The intervention will be carried out for eight weeks. The questionnaire will be completed in the first week and the 9th week. Method of measurement: The measurement of sleep quality will be done by the Pittsburgh questionnaire. The score obtained from the Pittsburgh questionnaire (score between 0 and 21), a score higher than 5 indicates unfavorable sleep quality, the higher the score of a person indicates unfavorable sleep quality. Faculty of Nursing and Midwifery, Kashan University of Medical Sciences Approved 2023-02-13 Ethics Committee in Research Faculty of Nursing and Midwifery, Health and Paramedicine- Kashan Unive Doctor's Boulevard- Qutb Ravandi Boulevard -Kashan kashan Isfehan Iran (Islamic Republic of)