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IRCT20221119056541N1 IRCT 2023-04-13 Rasht University of Medical Sciences The Effect of Aromatherapy with Lavender Oil on Behavioral and Physiological Indices The Effect of Aromatherapy with Lavender Oil on Behavioral and Physiological Indices Infants Undergoing Vaccination in Comprehensive Health Center 2023-04-06 anticipated 90 Complete https://irct.ir/trial/67013 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: First, the samples that meet the criteria for entering the research will be selected as available, and then they will be randomly sampled using the permutation block method with blocks of six in the form of ABCABC. SO that the letter "C" will be considered 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. The blocks will be registered and drawn in all possible situations. So that every time a lottery block is randomly selected and the obtained block is returned to the lottery container after registration. Sampling will continue until reaching the determined sample size in each group (30 people). To create a sequence after recording the different and possible states of placing three letters A, B and C in blocks of 6 and placing each letter in separate sheets, in the next step, the written papers are placed inside a container and using Randomly, every time one of the cards is removed from the said container and the letters are written on it in order and the desired card is returned to the container. The number of repetitions of the lottery will be determined after determining the number of the sample size, so that every time the letters on the sheet are removed, they will be added in the same order next to the previous letters. In the next step, sealed envelopes will be used for concealment. In this way, each of the determined letters is assigned a number equal to the determined sample volume, and the desired letter is placed inside an envelope and the number of that letter will be written on the envelope. The method of allocating the samples to each of the intervention, sham and control groups is that by choosing each infant who meets the criteria for entering the study, one of these envelopes is opened in the order of the number on the envelope and the letter inside the envelope is shown. to indicate which group that infant should be placed in.Random allocation software can also be used, Blinding description: In this study, the participants in the study who are infants are not aware of which group they are in (according to their age conditions) (of course, the parents of these children will be aware). Also, people who randomly assign groups and choose blocks A, B, and C for this purpose are not aware of which group each of the letters A, B, and C belongs to, and which group each person is in. Also, the person doing the analysis will not be aware of the groups. N/A Pain relief methods. 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%, were used during infancy and no serious side effects were reported.We will use 5 drops of 5% concentration. A research assistant is trained to implement the study protocol. He is not informed about the contents of the dishes. In the lavender group, the infants are placed in the vaccination bed 5 minutes before the intervention, the intensity of the basic pain is determined 5 minutes before the intervention, and then lavender oil inhalation will begin.Five drops of lavender oil are poured on a cotton ball and placed at a distance of 3 cm from the infant's nose, and the aromatherapy continues from 5 minutes before the intervention, during the intervention and 5 minutes after that, then the vaccine is injected. A skilled nurse administered all pentavalent vaccines during our study.Pain will be assessed 5 minutes before, during and 5 minutes after the injection. Video recording of the procedure is done for all infants and is reviewed at the right time. Physiological data (respiration rate, heart rate and percentage of arterial oxygen saturation) are evaluated by pulse oximetry device, 5 minutes before, during and 5 minutes after the injection. The number of breaths is also recorded by the assistant researcher after watching the videos. Intervention 2: Intervention group2: 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.In this study, distilled water will be used as a placebo. Both placebo and lavender oil are prepared in the same containers. A research assistant is trained to implement the study protocol. He is not informed about the contents of the dishes. In the distilled water group, infants are placed on the vaccination bed 5 minutes before the intervention, the intensity of the basic pain is determined 5 minutes before the intervention, and then the inhalation of distilled water will begin. Five drops of distilled water are poured on a cotton ball and placed at a distance of 3 cm from the infant's nose, and the aromatherapy continues 5 minutes before the intervention, during the intervention and 5 minutes after that, and then the vaccine is injected. A skilled nurse administered all pentavalent vaccines during our study. Pain will be assessed 5 minutes before, during and 5 minutes after the injection. Video recording of the procedure is done for all infants and is reviewed at the right time. Physiological data (respiration rate, heart rate and percentage of arterial oxygen saturation) are evaluated by pulse oximetry device, 5 minutes before, during and 5 minutes after the injection. The number of breaths is also recorded by the assistant researcher after watching the videos. Intervention 3: Control group: They will not receive any additional intervention. No - There is not a plan to make this available Justification or reason for not sharing IPD is Confidentiality of data
public Parichehr Shahroudi
18 Khazar Alley, Khazar Street, Lahijan
Rasht Iran (Islamic Republic of) 4414886939 +98 13 4234 6128 parichehr.shahroudi@gmail.com Rasht University of Medical Sciences scientific Parichehr Shahroudi
18 Khazar Alley, Khazar Street, Lahijan
Rasht Iran (Islamic Republic of) 4414886939 +98 13 4234 6128 parichehr.shahroudi@gmail.com Rasht University of Medical Sciences Iran (Islamic Republic of) 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 2 months 7 months Both Taking acetaminophen or any other pain reliever 3 hours before vaccination Having a history of hospitalization Suffering from diseases such as thyroid disorders, epilepsy and cardiovascular disease and acute diseases Having trouble sleeping or insomnia before the vaccine injection Z40-Z54 Pe XXI Factors influencing health status and contact with health services Prevention Placebo Other 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%, were used during infancy and no serious side effects were reported.We will use 5 drops of 5% concentration. A research assistant is trained to implement the study protocol. He is not informed about the contents of the dishes. In the lavender group, the infants are placed in the vaccination bed 5 minutes before the intervention, the intensity of the basic pain is determined 5 minutes before the intervention, and then lavender oil inhalation will begin.Five drops of lavender oil are poured on a cotton ball and placed at a distance of 3 cm from the infant's nose, and the aromatherapy continues from 5 minutes before the intervention, during the intervention and 5 minutes after that, then the vaccine is injected. A skilled nurse administered all pentavalent vaccines during our study.Pain will be assessed 5 minutes before, during and 5 minutes after the injection. Video recording of the procedure is done for all infants and is reviewed at the right time. Physiological data (respiration rate, heart rate and percentage of arterial oxygen saturation) are evaluated by pulse oximetry device, 5 minutes before, during and 5 minutes after the injection. The number of breaths is also recorded by the assistant researcher after watching the videos. Intervention group2: 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.In this study, distilled water will be used as a placebo. Both placebo and lavender oil are prepared in the same containers. A research assistant is trained to implement the study protocol. He is not informed about the contents of the dishes. In the distilled water group, infants are placed on the vaccination bed 5 minutes before the intervention, the intensity of the basic pain is determined 5 minutes before the intervention, and then the inhalation of distilled water will begin. Five drops of distilled water are poured on a cotton ball and placed at a distance of 3 cm from the infant's nose, and the aromatherapy continues 5 minutes before the intervention, during the intervention and 5 minutes after that, and then the vaccine is injected. A skilled nurse administered all pentavalent vaccines during our study. Pain will be assessed 5 minutes before, during and 5 minutes after the injection. Video recording of the procedure is done for all infants and is reviewed at the right time. Physiological data (respiration rate, heart rate and percentage of arterial oxygen saturation) are evaluated by pulse oximetry device, 5 minutes before, during and 5 minutes after the injection. The number of breaths is also recorded by the assistant researcher after watching the videos. Control group: They will not receive any additional intervention. 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. 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 Zylux Med 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. 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. Rasht University of Medical Sciences Approved 2022-08-17 Ethics Committee of Guilan University of Medical Sciences In Front of 17 Shahrivar Hospital, Shahid Siyadati St, Namjo St, Rasht Guilan Iran (Islamic Republic of)