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IRCT20210725051985N1 IRCT 2021-08-16 Bandare-abbas University of Medical Sciences The effect of foot reflexology massage on patients after femur surgery The effect of foot reflexology massage on pain intensity and limb movement in patients with operated femur fracture 2021-08-22 anticipated 112 Complete https://irct.ir/trial/57714 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random allocation will be done in the intervention and control group using Envelope Cards. According to the researcher, a number of envelopes containing cards are considered as the intervention group and the same number of envelopes containing cards for the control group; Then, by merging the cards together, a card is taken out and its allocation is recorded, and that card is returned to the group of other cards after being taken out. The cards are then merged again and another card is removed. This process continues until a random sequence according to the sample size is reached, Blinding description: Evaluation using visual acuity instrument (VAS) immediately and at 2, 4, 6, 12 hours after the first intervention and immediately and at 2, 4, 6, 12 hours after the second intervention until the postoperative day visit by the evaluator colleague The blind is done. The treating physician and physiotherapist (blind) will evaluate the patient's cooperation in moving the operated leg, which is related to the amount of movement, on the day after the operation and on the day of discharge, based on the limb movement evaluation checklist. In order to establish the blinding of the study, by providing the necessary explanations and relevant reasons, patients are asked not to inform anyone else about the intervention without consulting the researcher. And the statistics analyst is also blind. 3 Condition 1: Closed fracture of the femur. Condition 2: Patients' pain after femur surgery. Condition 3: Movement of patients' limbs after femur surgery. Intervention 1: Intervention group: Patients in the intervention group will receive a foot reflexology massage. In this study, the researcher will place the patient in a comfortable supine position. Disinfecting and washing the feet will be done at the beginning and at the end of the work. For 15 minutes, the healthy foot will be subjected to a reflexology massage technique using baby oil, which has no therapeutic value. The researcher will sit on a chair at the bottom of the patient's bed and massage as follows: and first the soles of the feet will be gently massaged, gentle movements and gentle massage will take 1 minute from the beginning and 1 minute from the last minutes of the massage. First, in a healthy foot, according to the foot massage reflection massage protocol, some of the first ten treatment techniques in this type of massage, which is a multiple of three, will be performed.And then we will do the same stimulation and stabilization techniques in the same way. The three sensitive points, which are the solar plexus, the pituitary gland and the heart, will be under constant pressure for 2 minutes (at any point) with the thumb. The pressure is such that the upper third of the researcher's thumb turns white and the patient feels this pressure but does not feel pain. These points will first be pressed steadily for two minutes and then massaged in a circular motion.The purpose of the massage is to move the thumbs in a circular motion in a clockwise direction and continuously on the reflection points without losing contact with the skin. This technique will be done the same for all patients and also the reflex massage of the sole of the foot for women. It will be done by the researcher and for men under the direct supervision of the researcher and by a trained male research colleague. Intervention 2: Control group: In this group, the trained researcher and colleague place the patients in a comfortable supine position. 6 hours after the surgery and also 12 hours after the first intervention, they lubricate the foot for one minute without any pressure to achieve the effect of touch. The dependent variable (pain) should be the same in both groups and controlled. They will also stay with the patient for 15 minutes to ensure that the effect of the presence of a massager is the same for both groups (14). The measurement of the patient's pain intensity in the same hours as the intervention group is done by a blind assessor and movement evaluation is done by the treating physician and physiotherapist in this group. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Yasaman Ghasempour Soleimani
Gharani Street., Shahid Bahonar Hospital
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3223 5011 yghasempour98@gmail.com Bandare-abbas University of Medical Sciences scientific Hadi Yousefi
Emam Hosein Blvd., University of Medical Sciences
Bandarabbas Iran (Islamic Republic of) 7916613885 +98 76 3331 7723 hadiyousefi17@gmail.com Bandare-abbas University of Medical Sciences Iran (Islamic Republic of) Conscious written and oral consent With closed femoral fracture Spinal anesthesia surgery Age 75-18 years At least six hours after surgery Awareness of place, time and person Enjoy complete health of sight and hearing 18 years 75 years Both Refer the patient to another medical center Early clearance Consumer of alcohol and other drugs History of similar intervention at least three months ago Wounds, fractures, deformities and skin disorders in the foot S72.3 G89.18 Fracture of femur acute postprocedural pain Rehabilitation N/A Intervention group: Patients in the intervention group will receive a foot reflexology massage. In this study, the researcher will place the patient in a comfortable supine position. Disinfecting and washing the feet will be done at the beginning and at the end of the work. For 15 minutes, the healthy foot will be subjected to a reflexology massage technique using baby oil, which has no therapeutic value. The researcher will sit on a chair at the bottom of the patient's bed and massage as follows: and first the soles of the feet will be gently massaged, gentle movements and gentle massage will take 1 minute from the beginning and 1 minute from the last minutes of the massage. First, in a healthy foot, according to the foot massage reflection massage protocol, some of the first ten treatment techniques in this type of massage, which is a multiple of three, will be performed.And then we will do the same stimulation and stabilization techniques in the same way. The three sensitive points, which are the solar plexus, the pituitary gland and the heart, will be under constant pressure for 2 minutes (at any point) with the thumb. The pressure is such that the upper third of the researcher's thumb turns white and the patient feels this pressure but does not feel pain. These points will first be pressed steadily for two minutes and then massaged in a circular motion.The purpose of the massage is to move the thumbs in a circular motion in a clockwise direction and continuously on the reflection points without losing contact with the skin. This technique will be done the same for all patients and also the reflex massage of the sole of the foot for women. It will be done by the researcher and for men under the direct supervision of the researcher and by a trained male research colleague. Control group: In this group, the trained researcher and colleague place the patients in a comfortable supine position. 6 hours after the surgery and also 12 hours after the first intervention, they lubricate the foot for one minute without any pressure to achieve the effect of touch. The dependent variable (pain) should be the same in both groups and controlled. They will also stay with the patient for 15 minutes to ensure that the effect of the presence of a massager is the same for both groups (14). The measurement of the patient's pain intensity in the same hours as the intervention group is done by a blind assessor and movement evaluation is done by the treating physician and physiotherapist in this group. Visual Analog Scale (VAS) Patient Pain Score. Timepoint: immediately at 2, 4, 6, 12 hours after the first intervention and immediately at 2, 4, 6, 12 hours after the second intervention until the day after surgery. Method of measurement: This scale is a horizontal ruler that is divided from zero to 10 and measures the severity of pain. The amount of pain is measured by the researcher using the Visual-Linear Pain Scale (VAS), which is standardized for measuring pain. The Linear-Visual Pain Scale is divided from zero to ten as follows:1-3 Mild pain4-7 moderate pain8-10 Severe painThe number zero means painless and the number 10 means very severe pain. Rank the amount of member movement based on the checklist. Timepoint: The day after surgery and the day of patient discharge. Method of measurement: In this checklist, questions related to moving the operated organ of the patient based on the comments and examination and observation of the treating physician and physiotherapist on the day after surgery and the day of discharge in the field of pain-relaxation-movement and patient cooperation as six options from No cooperation until very well described by the sign. Bandare-abbas University of Medical Sciences Approved 2021-07-23 Ethics committe of Hormozgan University of Medical Sciences Vice-chancellor for research, East side of the hospital, Shahid Mohammadi Hospital, Jomhouri Eslami Blv, Bandar Abbas, Hormozgan, Iran Bandarabbas Hormozgan Iran (Islamic Republic of)