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IRCT20200825048518N1 IRCT 2020-11-25 Tabriz University of Medical Sciences The effect of foot reflexology on pain intensity associated with fistula needle insertion The effect of foot reflexology on pain intensity associated with needle insertion into arteriovenous fistula in hemodialysis patients: a parallel randomized clinical trial study 2020-12-05 anticipated 60 Complete https://irct.ir/trial/50542 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients who will enter the study will be randomly assigned to two groups (reflexology recipient and one group receiving routine care) in a ratio of 1: 1 using a computer random number table with blocks of four and six. Blocking will be done by a non-involved person in sampling who is not aware of the objectives of the study, and the type of intervention received will be written on paper and numbered in a series of opaque envelopes (Allocation Concealment), Blinding description: The assistance of a researcher who registers the parameters and is unaware of the allocation groups will be considered a blind member. N/A Hemodialysis. Intervention 1: Intervention group: After the necessary coordination with the center and due to the current situation in the medical centers, after wearing personal protective equipment, the researcher and the research assistant will be present at the patient's bedside. After the patient enters the ward and is placed in a dialysis bed that has a well-lit and well-ventilated environment and is quiet, the intervention will begin after the necessary coordination with the head of the ward. After ensuring that the patient's legs are clean in a comfortable, semi-sitting position with the head at a 30-degree angle to the body and a small pillow under the legs for comfort, the fistula needle is placed by each patient's fixed nurse in shifts. Morning and evening work will be done in the dialysis ward of Imam Reza (AS) Hospital in Tabriz. In each session, only two patients will be evaluated. Five minutes after cleaning the skin surface with a 70% alcohol-soaked cotton swab, a hemodialysis needle will be inserted into the fistula area by each patient's fixed nurse. In all cases, the fistula needle is the same in terms of size (No. 16), shape and manufacturer and will enter the patient fistula at an angle of 20-30 degrees. The duration of each reflexology session will be 20 minutes starting from the right foot and continuing with the left foot (10 minutes reflexology for the right foot and 10 minutes reflexology for the left foot). Massage all parts of the right foot for 5 minutes, then massage for 5 minutes on the kidneys, under the big toe and the star network (solar plexus), then repeat these steps for the left foot. Foot reflexology by researchers After washing the hands, according to the patient's preference, his feet will be cleaned with water or a wet handkerchief. To prevent friction, turquoise baby oil made in Iran at room temperature, which has no therapeutic properties, will be used. During the intervention, the researcher will support the patient's foot with one hand and massage with the fingers of the other hand (mostly the big toe) with a gentle pressure as far as the patient can bear. In the reflexology group, patients with arteriovenous fistulas will be evaluated and recorded by a researcher after completing a 20-minute foot massage and immediately after the fistula needle is inserted. Physiological parameters are evaluated by the researcher before the intervention and then reflexology is performed for twenty minutes. After reflexology is completed, the fistula needle is inserted into the fistula by the ward nurse, after which the physiological parameters of the patients will be evaluated and recorded again by the researcher. Intervention 2: Control group: They will receive routine care, assessment of pain intensity and physiological parameters will be performed simultaneously with the reflexology group. Yes - There is a plan to make this available What will be shared: Study data can be published after the journals are accepted and published When: Access period starts 6 months after the results are published To whom: People who want to help hemodialysis patients are allowed to use the data Conditions: People who are researcher Where to obtain: The person in charge of the study How to obtain: Prove the purpose of the data request, which is to help hemodialysis patients, then send an email to the responsible author Comments:
public Seyedeh Faezeh Razavi Ghazani
Tabriz-School of Nursing and Midwifery
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 f.razavi1391@gmail.com Tabriz University of Medical Sciences scientific alehe seyyedrasooly
Tabriz - School of Nursing and Midwifery
Tabriz Iran (Islamic Republic of) 5138947977 +98 41 3479 6770 aleheseyedrasooli@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Being 18 years old and older Having full consciousness History of hemodialysis for at least 3 months from the desired fistula 18 years no limit Female Candidate for kidney transplant Patient death or withdrawal Get painkillers 12-8 before hemodialysis Drug addictions Neuropathological problems of skin diseases in the patient's legs Any type of wound and fracture, amputation and deep vein thrombosis in the leg Z49.01 Encounter for fitting and adjustment of extracorporeal dialysis catheter Other Other Intervention group: After the necessary coordination with the center and due to the current situation in the medical centers, after wearing personal protective equipment, the researcher and the research assistant will be present at the patient's bedside. After the patient enters the ward and is placed in a dialysis bed that has a well-lit and well-ventilated environment and is quiet, the intervention will begin after the necessary coordination with the head of the ward. After ensuring that the patient's legs are clean in a comfortable, semi-sitting position with the head at a 30-degree angle to the body and a small pillow under the legs for comfort, the fistula needle is placed by each patient's fixed nurse in shifts. Morning and evening work will be done in the dialysis ward of Imam Reza (AS) Hospital in Tabriz. In each session, only two patients will be evaluated. Five minutes after cleaning the skin surface with a 70% alcohol-soaked cotton swab, a hemodialysis needle will be inserted into the fistula area by each patient's fixed nurse. In all cases, the fistula needle is the same in terms of size (No. 16), shape and manufacturer and will enter the patient fistula at an angle of 20-30 degrees. The duration of each reflexology session will be 20 minutes starting from the right foot and continuing with the left foot (10 minutes reflexology for the right foot and 10 minutes reflexology for the left foot). Massage all parts of the right foot for 5 minutes, then massage for 5 minutes on the kidneys, under the big toe and the star network (solar plexus), then repeat these steps for the left foot. Foot reflexology by researchers After washing the hands, according to the patient's preference, his feet will be cleaned with water or a wet handkerchief. To prevent friction, turquoise baby oil made in Iran at room temperature, which has no therapeutic properties, will be used. During the intervention, the researcher will support the patient's foot with one hand and massage with the fingers of the other hand (mostly the big toe) with a gentle pressure as far as the patient can bear. In the reflexology group, patients with arteriovenous fistulas will be evaluated and recorded by a researcher after completing a 20-minute foot massage and immediately after the fistula needle is inserted. Physiological parameters are evaluated by the researcher before the intervention and then reflexology is performed for twenty minutes. After reflexology is completed, the fistula needle is inserted into the fistula by the ward nurse, after which the physiological parameters of the patients will be evaluated and recorded again by the researcher. Control group: They will receive routine care, assessment of pain intensity and physiological parameters will be performed simultaneously with the reflexology group. Pain. Timepoint: When inserting a needle into a venous artery fistula. Method of measurement: Pain intensity in patients with arteriovenous fistula using the VAS instrument, which is a rule-like diagram numbered from zero to ten; Will be evaluated. The Linear-Visual Pain Scale is divided from zero to ten so that zero means painless and ten means maximum pain. Physiological parameters. Timepoint: Before and immediately after insertion of the needle into the venous artery fistula. Method of measurement: Blood pressure and heart rate with a physiological device for measuring digital blood pressure and blood oxygen saturation level by a device for measuring blood oxygen saturation level. Tabriz University of Medical Sciences Approved 2020-11-25 Tabriz University of Medical Sciences - School of Nursing and Midwifery Tabriz - University Street - Research Deputy Tabriz East Azarbaijan Iran (Islamic Republic of)