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IRCT20230122057181N1 IRCT 2023-06-06 Artesh University of Medical Sciences Investigating the effect of foot massage on comfort, muscle cramps and nausea The effect of foot reflexology on relief ، muscle cramp and nausea during hemodialysis in patients undergoing hemodialysis in the selected military hospital. 2023-05-30 anticipated 52 Complete https://irct.ir/trial/68391 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Prevention, Randomization description: Patients eligible to be included in the study based on the criteria of random allocation by variable blocks method (if A: intervention group, B: control group, there will be six different states for blocks of 4: 1. AABB 2. ABAB 3. ABBA 4. BBAA 5. BABA 6. BAAB that blocks can be written on paper and taken from inside the bag) will be distributed in two groups. In this way, after explaining the method and objectives of the study to the patients and, if necessary, their families and obtaining informed consent from them, they are randomly assigned to two intervention and control groups. In this way, the first patient will be in the intervention group and the second patient will be in the control group, and the same will be observed until the last patient, Blinding description: Because the properties of chronic diseases and chronic hemodialysis patients are influenced by each other so that they have a great influence on each other from their experiences. In order to prevent this from happening and for the patients' answers in the questionnaires to be real and not influenced by other patients, we separated the intervention and control groups, so that even days the intervention group receives the desired massage and Individuals in the control group receive the usual intervention in the dialysis department. In this way, they did not face each other and the control group did not see the desired massage and intervention. N/A Hemodialysis, dialysis, reflexology massage. Intervention 1: Intervention group: The researcher will perform reflex massage on both feet of the patient (each foot for 15 minutes) and for a total of half an hour. A slippery substance such as lubricant gel is used. In the area under the patient's toes, in the reflective area related to the kidneys (in areas 2 and 3 in the middle line of the foot), in the middle part under the big toe, the area related to digestive problems to reduce nausea, the solar plexus area for comfort and reducing cramps. Muscular as well as the part related to the sciatic nerve which is above the heel and close to the center of the massage will be done for each leg for 15 minutes. In general, for all people in the intervention group, the massage will start from the right foot and last 30 minutes in total. This intervention is performed once per session and for three consecutive hemodialysis sessions (per week). For the intervention group, before the reflex massage, at the beginning of the week, Kolkaba's general comfort questionnaire and the Rhodes questionnaire will be provided to them to assess nausea and will be completed by them. It will be done at the end of the week, and at the end of the week, comfort and nausea questionnaires will be provided to the patients, and muscle cramp monitoring will be done. Intervention 2: Control group: For the control group, reflexology massage is performed three times a week on false points and points other than the 2nd and 3rd midline of the foot, under the big toe and the solar plexus area, which are the study points of the researcher. The massage will be performed by a trained researcher and will be performed with the thumb in the form of sliding and sliding movements. Due to ethical considerations and non-acceptance of female patients to perform reflex massage on the soles of the feet, the intervention will only be performed for male patients of the hemodialysis department. The pressure will be in such a way that resistance and stiffness will be felt under the thumb. No intervention will be done for the control group. For these patients, according to the plan (on odd days of the week), questionnaires will be given to them at the beginning of the week, and at the end of the week, the questionnaires will be completed by them again and information will be collected. Yes - There is a plan to make this available What will be shared: Potential data can be shared after the completion of the research and after de-identifying people, for example, data such as pre- and post-intervention questionnaires regarding nausea and vomiting, comfort and cramps, etc. can be shared. . When: The start of the access period from the second half of 2023 To whom: Data can be accessed by all researchers working in academic and scientific centers or even researchers personally. Conditions: Analyzes related to this research so that this similarity completes the previous research. Also, for the final access to the data and analysis, it is necessary for the person to send his/her profile and request to my email in order to receive the desired information as soon as possible. I will send it to them. Where to obtain: To use the data, please send a request to the address mh.sajadian@gmail.com or to the library of the Faculty of Nursing of Army University of Medical Sciences located in Tehran, Shariati St., in front of Bahar Shiraz St., Kaj St., next to the Army Family Hospital, Faculty of Nursing Request and study student's reference and thesis from this library. How to obtain: From the time I receive the email and review it, I will respond to it as soon as possible... To estimate the response time, the requested information and data will be sent to Ishal within three days of receiving the email. Comments: To send a request for information, first send it to the email address: mh.sajadian@gmail.com and if the desired answer is not received within three days, send your request to the email address afaghi8181@gmail.com.
public Effat Afaghi
Army University of Medical Sciences,Etemadzadeh Street, Fatemi Ave, Shariati Blvd
Tehran Iran (Islamic Republic of) 1411718541 +98 21 4382 2449 afaghi8181@gmail.com Artesh University of Medical Sciences scientific Effat Afaghi
Army University of Medical Sciences, Etemadzadeh Street, Fatemi Ave, Shariati Blvd
Tehran Iran (Islamic Republic of) 1411718541 +98 21 4382 2449 afaghi8181@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) Age above 18 years and below 75 years At least 6 months under hemodialysis treatment Dialysis three or more times a week Absence of acute infection Absence of muscular-skeletal disorders such as multiple sclerosis, severe heart and respiratory failure mentioned in the patient's medical history or mentioned by the patient and companions Absence of chronic inflammatory disease of unknown origin Absence of skin diseases on the feet (such as psoriasis, fungal diseases, any wounds, including diabetic foot ulcers) absence of thrombosis and blood supply disorders Not using drugs, alcohol and smoking 18 years 75 years Male Unwillingness to continue cooperation or the occurrence of any complications Absence of more than two sessions during study Skin sensitivity or allergy to lubricant gel Hemodynamic disturbance during hemodialysis such as severe drop in blood pressure A history of hospitalization in neuropsychiatric departments or taking neuropsychiatric drugs Use of anti-nausea drugs before reflexology massage Confirmation of any of the problems and diseases mentioned in the entry criteria during the study Treatment - Other Treatment - Other Intervention group: The researcher will perform reflex massage on both feet of the patient (each foot for 15 minutes) and for a total of half an hour. A slippery substance such as lubricant gel is used. In the area under the patient's toes, in the reflective area related to the kidneys (in areas 2 and 3 in the middle line of the foot), in the middle part under the big toe, the area related to digestive problems to reduce nausea, the solar plexus area for comfort and reducing cramps. Muscular as well as the part related to the sciatic nerve which is above the heel and close to the center of the massage will be done for each leg for 15 minutes. In general, for all people in the intervention group, the massage will start from the right foot and last 30 minutes in total. This intervention is performed once per session and for three consecutive hemodialysis sessions (per week). For the intervention group, before the reflex massage, at the beginning of the week, Kolkaba's general comfort questionnaire and the Rhodes questionnaire will be provided to them to assess nausea and will be completed by them. It will be done at the end of the week, and at the end of the week, comfort and nausea questionnaires will be provided to the patients, and muscle cramp monitoring will be done. Control group: For the control group, reflexology massage is performed three times a week on false points and points other than the 2nd and 3rd midline of the foot, under the big toe and the solar plexus area, which are the study points of the researcher. The massage will be performed by a trained researcher and will be performed with the thumb in the form of sliding and sliding movements. Due to ethical considerations and non-acceptance of female patients to perform reflex massage on the soles of the feet, the intervention will only be performed for male patients of the hemodialysis department. The pressure will be in such a way that resistance and stiffness will be felt under the thumb. No intervention will be done for the control group. For these patients, according to the plan (on odd days of the week), questionnaires will be given to them at the beginning of the week, and at the end of the week, the questionnaires will be completed by them again and information will be collected. Comfort score in Kolkaba General Comfort Questionnaire. Timepoint: Before and after the intervention. Method of measurement: (Kolkaba General Comfort Questionnaire to measure comfort). Nausea score in Rhodes index of nausea and vomiting. Timepoint: Before and after the intervention. Method of measurement: Rhodes index of nausea and vomiting. Number of muscle cramps during hemodialysis. Timepoint: Before and after the intervention. Method of measurement: Numeric scale. Artesh University of Medical Sciences Approved 2022-11-20 Ethics Committee of Army Medical Sciences University Aja university, Etemadzade Ave, Docter fatemi Ave, Shariati Blvd Tehran Tehran Iran (Islamic Republic of)