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IRCT20230202057303N3 IRCT 2024-04-19 Deputy of research and technology of Iran University of Medical Sciences The effect of Foot Reflexology Massage on Delirium and Physiological Indicators in Children Admitted to Pediatric Intensive Care Unit: A randomized clinical trial The effect of Foot Reflexology Massage on Delirium and Physiological Indicators in Children Admitted to Pediatric Intensive Care Unit: A randomized clinical trial 2024-04-29 anticipated 74 Complete https://irct.ir/trial/75972 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Using computerized randomization (www.randomizer.org), continuously selected children will be placed in the control group and the intervention group. N/A Delirium. Intervention 1: Intervention group: Foot Reflexology Massage- foot massage includes the steps of preparation, heating and relaxation. In the preparation phase, all children will be given towels and shampoo to wash their feet. The researcher will massage the hands together with a small amount of baby oil to make the soles of the feet slippery, while creating a suitable and even heat for the hand. The heating stage is actually a basic and general type of massage that is aimed at familiarizing the foot with the hands of the masseur. In the relaxation phase, the reflex points of the brain, pituitary, hypothalamus, heart, lungs, and solar plexus will be massaged on both feet for 10 minutes. This massage will be done on 2 consecutive days. Intervention 2: Control group: No intervention is received. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mona Alinejad-Naeini
Nursing and Midwifery Faculty of Iran University of Medical Sciences, Rashid Yasmi St., Valiasr St.
Tehran Iran (Islamic Republic of) 1436944694 +98 21 4365 1605 alinejad.m@iums.ac.ir Iran University of Medical Sciences scientific Mona Alinejad-Naeini
Nursing and Midwifery Faculty of Iran University of Medical Sciences, Rashid Yasmi St., Valiasr St.
Tehran Iran (Islamic Republic of) 1436944694 +98 21 4365 1605 alinejad.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Failure to score 4- and 5- on the Richmond Agitation Scale Age 6-12 years old Hospitalization in the pediatric intensive care unit for at least 3 days Absence of abnormalities such as corns, wounds, previous scars, burns, amputations, and skin diseases on the legs. Absence of vascular injuries in the lower limbs and absence of sensory-motor disorders (confirmed by a neurologist) in the legs Diagnosis of delirium by obtaining a delirium score of 9 and above based on the Cornell scale and a pediatric neurologist No previous experience of foot reflexology massage before the study Confirmation of the doctor's diagnosis by a pediatric specialist 6 years 12 years Both Mechanical ventilation Taking a X Ray and performing an invasive procedure due to the occurrence of restlessness and disturbance in the massage Children's restlessness Lack of proper cooperation and resistance of the child and his parents at any time of the study Emergency conditions such as cardiopulmonary resuscitation or seizures Child suffering from acute heart or respiratory diseases Reduction of vital signs more than expected, such as: drop in blood pressure (below 25th percentile) and bradycardia (below 65 beats per minute) F05 Delirium, not induced by alcohol and other psychoactive substances Treatment - Other N/A Intervention group: Foot Reflexology Massage- foot massage includes the steps of preparation, heating and relaxation. In the preparation phase, all children will be given towels and shampoo to wash their feet. The researcher will massage the hands together with a small amount of baby oil to make the soles of the feet slippery, while creating a suitable and even heat for the hand. The heating stage is actually a basic and general type of massage that is aimed at familiarizing the foot with the hands of the masseur. In the relaxation phase, the reflex points of the brain, pituitary, hypothalamus, heart, lungs, and solar plexus will be massaged on both feet for 10 minutes. This massage will be done on 2 consecutive days. Control group: No intervention is received Delirium. Timepoint: 5 minutes before the intervention - immediately after the intervention. Method of measurement: Cornell Assessment of Pediatric Delirium (CAPD). Physiological Indicators. Timepoint: 5 minutes before the intervention - immediately after the intervention. Method of measurement: Monitoring connected to the child. Deputy of research and technology of Iran University of Medical Sciences Approved 2023-11-15 Working Group/Committee of Ethics in Research of Iran University of Medical Sciences Nursing and Midwifery Faculty, Rashid Yasmi St., Valiasr St. Tehran Tehran Iran (Islamic Republic of)