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IRCT20130412012990N10 IRCT 2019-06-15 Rasht University of Medical Sciences Survey the Effect of Foot Reflexology on Physiological Indices, Pain Level and Crying of Infants under Vaccination Survey the Effect of Foot Reflexology on Physiological Indices, Pain Level and Crying of Infants under Vaccination 2019-06-22 anticipated 90 Complete https://irct.ir/trial/39740 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Health service research, Randomization description: At first, samples with entry criteria will be census sampled and Then randomly sampled using ABCABC permutation blocks with six blocks.As the letter "C" as the control group, the letter "B" will be considered as the sham group and the letter "A" will be considered as the intervention group.Blocks will be recorded and drawn in all possible scenarios.So that each lottery block is randomly selected and the block obtained after registration is returned to the lottery box.Sampling will continue to reach the sample size determined in each group (30 people). To create sequences after registering different states and possible three letters A, B and C in blocks 6 and placement of each letter in separate sheets, placed in the next step of the paper in the container and using a lottery randomly each time one of the sheets was dropped out of the container and the letters on it were written in sequence, and the desired sheet was returned to the container again.The number of times the lottery will be determined after specifying the sample number will be specified,So that Each time the letters on the tab will be added along with the previous letters in the same order.To create random assignments, the following software can also be used: Random allocatin software. The next step is to hide the closed envelopes.In such a way that each of the designated letters is assigned a number to the number of specified sample sizes and the letter is placed inside an envelope and the number of that letter will be written on the envelope. The method of assigning samples to each intervention, sham and control group is that by selecting any infant who has the criteria for entering the study, one of these packs will be opened, respectively, the word in the envelope indicates that infant should be in which of the groups, Blinding description: The participant does not know which of the three groups is the intervention, sham or control. N/A Physiological and behavioral indices of pain, duration of crying. Intervention 1: Intervention group: The intervention will be carried out by the researcher who holds the reflexology certificate.The intervention method will be used by the researcher to wash his hands and, to reduce the friction, it will be impregnated with a neutral, non-curative baby oil.This oil is produced by Firouz's Health Group, which has the ability to soothe and maintain the skin's moisture.After warming the hands, each leg will undergo a general massage for warming for one minute.Then, while keeping the researcher with his left hand, holding his infant's leg, with his right finger, he will massage The area of the thighs on the foot of each foot for 15 minutes (a total of 30 minutes per infant). Intervention 2: Intervention group: The intervention method will be used by the researcher to wash his hands and, to reduce the friction, it will be impregnated with a neutral, non-curative baby oil.This oil is produced by Firouz's Health Group, which has the ability to soothe and maintain the skin's moisture.After warming the hands, each leg will undergo a general massage for warming for one minute.Then, the researcher will massage the neutral point (foot area under the ankle) on each foot for 15 minutes (a total of 30 minutes per infant). Intervention 3: Control group: In the control group, vaccination will be performed according to the usual routine of the center. No - There is not a plan to make this available Justification or reason for not sharing IPD is privacy of the data
public Parichehr Shahroudi Tamrin
Yakhsazi Square, Hamidian Town, Rasht City
Rasht Iran (Islamic Republic of) 4148853699 +98 13 3355 2418 parichehr.shahroudi@gmail.com Rasht University of Medical Sciences scientific Minoo Mitra Chehrzad
Shahid Beheshti Nursing and Midwifery Faculty of Rasht
Rasht Iran (Islamic Republic of) 4146939841 +98 133355058 mchehrzad@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Age 2 to 7 months Being in a normal percentile of weight and height when receiving vaccine was born term (38-42 weeks gestation) to be calm and not crying before vaccination Body temperature between 36- 37. 2° C 2 months 7 months Both Not taking acetaminophen or any other analgesic 3 hours before vaccination Not having a history of hospitalization Lack of diseases such as thyroid disorders, epilepsy, cardiovascular disease and acute diseases that reduces the level of consciousness of the child. Not having bad sleep or sleeplessness before vaccination Z00.12 Encounter for routine child health examination Other Placebo Other Intervention group: The intervention will be carried out by the researcher who holds the reflexology certificate.The intervention method will be used by the researcher to wash his hands and, to reduce the friction, it will be impregnated with a neutral, non-curative baby oil.This oil is produced by Firouz's Health Group, which has the ability to soothe and maintain the skin's moisture.After warming the hands, each leg will undergo a general massage for warming for one minute.Then, while keeping the researcher with his left hand, holding his infant's leg, with his right finger, he will massage The area of the thighs on the foot of each foot for 15 minutes (a total of 30 minutes per infant). Intervention group: The intervention method will be used by the researcher to wash his hands and, to reduce the friction, it will be impregnated with a neutral, non-curative baby oil.This oil is produced by Firouz's Health Group, which has the ability to soothe and maintain the skin's moisture.After warming the hands, each leg will undergo a general massage for warming for one minute.Then, the researcher will massage the neutral point (foot area under the ankle) on each foot for 15 minutes (a total of 30 minutes per infant). Control group: In the control group, vaccination will be performed according to the usual routine of the center. Pain level in the FLACC behavioral checklist. Timepoint: At first,the level of infant's pain in three groups of intervention, sham and control for one minute before massage is measured and recorded.Then massage performed for each group(Massage at the relevant points in the intervention group and neutral massage in the sham group).After this stage, the pain level will be measured and recorded for one minute in each of the three intervention, sham and control groups before the painful stimulus (after massage) and during painful stimulation (vaccine injection). Method of measurement: Using the FLACC scale (Face, Leg, Activity, Cry, Consolability), an appropriate tool for assessing pain-related behaviors in children ages 2 months to 7 years.This scale has 5 sections and examines the severity of pain through face reactions, leg positions,activity , crying and consolability.Each of these sections gives a score of 0 to 2, which ultimately brings together scores. Based on the overall score, zero score means no pain and 10 means the sharpest pain level.The overall score is divided into three levels: score 0 to 3 represents a reduction in pain, 4 to 7 represents moderate pain, and 7 to 10 means severe pain. Mean score of physiological indices(Heart rate, Arterial blood oxygen saturation), average crying time. Timepoint: At first, the physiological indices of infants in three groups of intervention, sham and control by pulse oximeter are measured and recorded for one minute before massage.Massage will then be performed for each group (massage at the relevant points in the intervention group and neutral area massage in the sham group).After this stage, physiological indices for one minute will be measured and recorded in each of the three intervention, sham and control groups before the painful stimulus (after massage) and during the acute stimulus (vaccine injection) are performed. Method of measurement: To measure physiological indices (arterial blood oxygen saturation, heart rate), a child finger pulse oximeter ,The brand Zyklusmed, will be used with China's CMS 50 QB code.The Galaxy J7 Pro SM-J730F stopwatch will be used to measure infant crying time. Rasht University of Medical Sciences Approved 2019-05-11 Ethics committee of Guilan University of Medical Sciences Opposite the 17 Shahrivar Hospital, ShahidSiadati Streethid, Namjoo Street Rasht Guilan Iran (Islamic Republic of)