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IRCT20190130042555N1 IRCT 2019-09-30 Hamedan University of Medical Sciences The effect of foot massage on pain severity due to intravenous catheter insertion in hospitalized preschool children The effect of foot massage on pain severity due to intravenous catheter insertion in hospitalized preschool children at pediatric ward of Hamadan Besat Hospital 2019 2019-09-23 anticipated 60 Complete https://irct.ir/trial/42039 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention. N/A Pain. Intervention 1: Intervention group:Intervention includes simple foot massage. It is performed on children aged 3 to 6 years in the pediatric ward and before venipuncture. In the experimental group, if they meet the inclusion and exclusion criteria, the child will go to the examination room with the mother. First, the child's physiological parameters, including heart rate and blood oxygen saturation, will be recorded using a calibrated pulse oximeter. Then the simple foot massage for 5 minutes is given. The method is to massage the child lying on the bed, and researcher at the bottom of your feet and hands with baby oil fatty child is the first all parts of the foot; the foot; heel and toes gently massage. Take the Foot with one hand and press the foots slowly with the other. With one thumb is make rotational movements of the heel. It performs movements in both legs. Immediately after the massage Venipuncture performed. And at the beginning of venipuncture, IV arrival time to the skin, pain assessment scale FLACC will be completed by the researcher and physiological parameters will be recorded. Physiological indices are recorded again two minutes after venipuncture and pain assessment scale FLACC will be completed by the researcher. Intervention 2: Control group: In the Control group if you have to study inclusion and exclusion criteriaĜŒ Child with his mother will go in the examination room. The control group did not Intervention, and children receive routine care, then the child's physiological indicators including heart rate and blood oxygen saturation using a calibrated pulse oximetry will be recorded. And at the beginning of venipuncture, IV arrival time to the skin, pain assessment scale FLACC will be completed by the researcher and physiological parameters will be recorded. Two minutes after venipuncture, physiological parameters will be recorded again and the FLACC pain scale will be completed by the researcher. 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 No more information
public Tayebeh Hasan Tehrani
Hamadan University of Medical Sciences, Shahid Fahmideh Street, Hamadan, Iran
Hamadan Iran (Islamic Republic of) 6517838698 +98 81 3838 0150 t.tehrani@umsha.ac.ir Hamedan University of Medical Sciences scientific Tayebeh Hasan Tehrani
Hamadan University of Medical Sciences, Shahid Fahmideh Street,
Hamadan Iran (Islamic Republic of) 6517838698 +98 81 3838 0150 t.tehrani@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Child hospitalized 3 to 6 years Organ and skin health in the legs No analgesic medication for 3 hours before venipuncture A child's consciousness of place and time and person Lack of mental retardation No respiratory problems No congenital heart disease First time hospitalized child The second time Venipuncture No acute pain during Venipuncture The pain that a child suffers from illness Such as severe pain Fracture or tumor pain The child is not feverish No history of surgery No history of intravenous and intramuscular injection 3 years 6 years Both Unwilling to continue participating in the study Touch sensitivity Failure to Venipuncture the first time G89.1 Acute pain, not elsewhere classified Prevention Other Intervention group:Intervention includes simple foot massage. It is performed on children aged 3 to 6 years in the pediatric ward and before venipuncture. In the experimental group, if they meet the inclusion and exclusion criteria, the child will go to the examination room with the mother. First, the child's physiological parameters, including heart rate and blood oxygen saturation, will be recorded using a calibrated pulse oximeter. Then the simple foot massage for 5 minutes is given. The method is to massage the child lying on the bed, and researcher at the bottom of your feet and hands with baby oil fatty child is the first all parts of the foot; the foot; heel and toes gently massage. Take the Foot with one hand and press the foots slowly with the other. With one thumb is make rotational movements of the heel. It performs movements in both legs. Immediately after the massage Venipuncture performed. And at the beginning of venipuncture, IV arrival time to the skin, pain assessment scale FLACC will be completed by the researcher and physiological parameters will be recorded. Physiological indices are recorded again two minutes after venipuncture and pain assessment scale FLACC will be completed by the researcher. Control group: In the Control group if you have to study inclusion and exclusion criteriaĜŒ Child with his mother will go in the examination room. The control group did not Intervention, and children receive routine care, then the child's physiological indicators including heart rate and blood oxygen saturation using a calibrated pulse oximetry will be recorded. And at the beginning of venipuncture, IV arrival time to the skin, pain assessment scale FLACC will be completed by the researcher and physiological parameters will be recorded. Two minutes after venipuncture, physiological parameters will be recorded again and the FLACC pain scale will be completed by the researcher. The effect of foot massage on pain Severity due to Intravenous catheter insertion. Timepoint: During venipuncture, two minutes after venipuncture. Method of measurement: Pain Assessment Scale (FLACC) (Face, Leg, Activity Cry, Consolability). Pulse rate. Timepoint: Before venipuncture, during venipuncture, two minutes after venipuncture. Method of measurement: Device of pulse oximeter. Arterial Oxygen Saturation Percentage. Timepoint: Before venipuncture, during venipuncture, two minutes after venipuncture. Method of measurement: Device of pulse oximeter. Pain. Timepoint: During venipuncture, two minutes after venipuncture. Method of measurement: Pain Assessment Scale (FLACC) (Face, Leg, Activity, Cry, Consolability). Hamedan University of Medical Sciences Approved 2019-05-18 Ethics committee of Hamadan University of Medical Sciences Hamadan University of Medical Sciences, Research Square, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)