Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»Iranian Registry of Clinical Trials
Year
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2023
INTERVENTION: Intervention 1: Intervention group1: The condition of light, lighting and temperature of the environment is the same for all infants. At the beginning of data collection, all the infants are awake, without crying and in calm conditions.Their diapers are dry and they have not received any food, including milk or other sweets, at least 30 minutes before the start of vaccination.In the condition that the infant is in a calm state, the researcher fixed the finger pulse oximeter on the infant's toe by means of a piece of hypoallergenic adhesive without creating additional pressure, and then 5 minutes before the start of the vaccination, the responses were not given. Grading is done from the beginning to the end of the procedure. This work is done by the observer from the beginning to the end of the vaccination. shaking and any other actions will be avoided during the entire intervention period. At the same time as the needle enters the skin, the sound of the infant's cry is recorded.The criterion for the beginning and end of crying is based on the definition of the first cry from the first audible sound to the first pause that lasts at least five seconds. On the one hand, after the needle is fully inserted into the skin, the number of heart beats per minute, the oxygen saturation percentage of the arterial blood, and the breathing rate are recorded again.During the entire duration of vaccination, the cotton will be kept without close contact with the baby's nose. According to the purpose of the research, the data collection tools include a demographic questionnaire, a pain checklist, a pulse oximetry device, and a Chronometer device . Lavender oil will be procured from Sobhan Pharmaceutical Company.In previous studies, different concentrations of lavender oil, up to 10%, CONDITION: Pain relief methods. ; XXI Factors influencing health status and contact with health services Z40‐Z54 Pe PRIMARY OUTCOME: Pain level. Timepoint: The pain level will be evaluated 5 minutes before, during and 5 minutes after the injection of the vaccine. Method of measurement: Using the Face, Legs, Activity, Cry, Consolability scale (FLACC scale) , Which is a suitable tool for evaluating pain‐related behaviors in children aged 2 months to 7 years. This scale has 5 parts and examines the level of pain through facial reactions, the way the legs are placed, the amount of mobility, crying and relaxation. A score of 0 to 2 is assigned to each of these sections, and finally the scores are added together. Based on the overall score, a score of zero means no pain and 10 means the most severe level of pain. The overall score is divided into three levels: a score of 0 to 3 indicates reduced pain, 4 to 7 indicates moderate pain, and 7 to 10 means severe pain. INCLUSION CRITERIA: Age 2 to 7 months Being in the normal percentile of weight and height growth when receiving the vaccine Term (38 to 42 weeks of pregnancy) to be calm and not crying the infant before receiving the vaccine The temperature is between36 to 37.2 degrees Celsius SECONDARY OUTCOME: Duration of crying. Timepoint: At the same time as the needle enters the skin, the sound of the infant's cry is recorded. The criterion for the beginning and end of crying is based on the definition of the first cry from the first audible sound to the first pause that lasts at least five seconds. Method of measurement: Galaxy J7 Pro model SM‐J730F chronometer will be used to measure the duration of infant crying. Physiological indices. Timepoint: Physiological indices (respiration rate, heart rate and arterial oxygen saturation percentage) will be evaluated by pulse oximetry device, 5 minutes before, during and 5 minutes after the vaccine injection. Method of measurement: In order to measure the physiological indicators (arterial blood oxygen saturation level, heart rate), a children's finger pulse oximeter device of Zylu XMed brand with code CMS 50 QB made in China will be used. To measure the breathing rate, the researcher will help after vision The videos record the number of breaths.
Epistemonikos ID: fb419522aeea37a727b4141902e582e5fd45ef41
First added on: Feb 20, 2024