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IRCT20200918048750N2 IRCT 2023-08-08 Zahedan University of Medical Sciences Comparison of the effect of auditory and tactile stimulation on nutritional adequacy and physiological indicators of premature infants Comparison of the effect of auditory and tactile stimulation on nutritional adequacy and physiological indicators of premature babies hospitalized in neonatal intensive care 2023-08-22 anticipated 90 Complete https://irct.ir/trial/71622 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Infants born at least 32 weeks are pre-terminated, Randomization description: Sampling will be done by available methods. All premature babies hospitalized in the neonatal intensive care unit of Ali Ibn Abi Talib Zahedan Hospital who meet the inclusion criteria will be included in the study. Then the selected babies are randomly divided into three groups: auditory stimulation, tactile stimulation and control group. In this way, first, envelopes containing the names of the groups will be prepared for the total number of studied samples and randomly arranged, and gradually, one of the cards will be assigned to them, which will determine the individual's group in the intervention or control group. N/A Premature infants. Intervention 1: f the patient was placed in the auditory stimulation intervention group, the demographic questionnaire form was first filled by the researcher, before the intervention, an individual training session was held for the mother and baby for 30 to 45 minutes and the method of auditory stimulation was explained, which includes reading a lullaby in the mother's own dialect. will be At 8 o'clock in the morning, the amount of milk prescribed by the doctor is poured into the syringe (SUPA) and given to the baby through the mouth by the researcher, and the amount of cc per minute is recorded, as well as the physiological indicators (heart rate, breathing rate and blood oxygen saturation percentage) It is measured by monitoring with the SAADAT brand, whose probe is attached to the baby's right hand. In the next step, at 10 o'clock in the morning, the mother will be present at the baby's bedside, for three minutes, a lullaby for baby, immediately after the intervention of the milk amount. The order given by the doctor was poured into the syringe and given to the baby through the mouth by the researcher, and the amount of cc per minute is recorded and the physiological indicators are also measured. Intervention 2: If the patient is included in the tactile stimulation intervention group, first the demographic questionnaire form will be completed by the researcher and an individual training session will be held for the mother of the baby for 30 to 45 minutes and how to perform the tactile stimulation that is taught to the mothers in such a way that first they must disinfect their hands with an antibacterial solution, after warming the hand under the warmer, place one hand in a cup shape around the baby's head above the eyebrow line and place the other hand on the lower abdomen around the baby's waist and hips. The hands should be placed gently on the baby's body and only the hand should be in contact with the baby and no pressure should be applied to the baby's body. At 8 o'clock in the morning, the amount of milk ordered by the doctor is poured into the syringe (SUPA) and is given to the baby through the mouth by the researcher , and the amount of cc per minute is recorded, the physiological indicators (heart rate and breathing rate and percentage blood oxygen saturation is measured by monitoring with SAADAT brand, whose probe is attached to the baby's right hand. In the next step, the mother is present at the baby's bedside at 9:45 a.m., and she is asked to perform tactile stimulation for 15 minutes. Then, at 10 o'clock, the amount of milk ordered by the doctor is poured into the syringe, it is given to the baby through the mouth, and the amount of cc per minute is noted, and the physiological indicators are also measured. Intervention 3: Control group: First, the demographic questionnaire form was completed by the researcher at 8 o'clock in the morning, after changing the diaper, the amount of milk ordered by the doctor was poured into the syringe and given to the baby through the mouth by the researcher, and the amount of cc per minute was noted. Physiological indicators are also measured. The infants of this group do not receive any intervention except for routine care according to the hospital's policy, again at 10 o'clock nutrition adequacy and physiological indicators are measured 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 There is no more information
public Mahnaz Ghaljeh
37 University St, Yaqut Building, Unit 5
Zahedan Iran (Islamic Republic of) 3619676483 +98 45 3342 0641 ghaljeh.m@gmail.com Zahedan University of Medical Sciences scientific Mahnaz Ghaljeh
37 University St, Yaqut Building, Unit 5
Zahedan Iran (Islamic Republic of) 3619676483 +98 45 3342 0641 ghaljeh.m@gmail.com Zahedan University of Medical Sciences Iran (Islamic Republic of) Persistence of infant's physiological symptoms No respiratory distress Not using narcotic drugs and sedatives for the baby Apkar score between 8-10 Completion of the consent form of the baby to participate in the research by the father or mother Absence of congenital anomalies Feeding babies with stored breast milk Low birth weight babies weighing 1500 to 2500 grams 4 days 7 days Both Seizure of the baby to be discharged Death of a baby Changes in the clinical condition of the baby, such as intubation of the baby hemodynamic disorder during the study (heart rate more than 180 or less than 100 times per minute, breathing more than 60 or less than 30 times per minute, decrease in arterial blood oxygen saturation percentage less than 86%) Behavior Behavior Behavior f the patient was placed in the auditory stimulation intervention group, the demographic questionnaire form was first filled by the researcher, before the intervention, an individual training session was held for the mother and baby for 30 to 45 minutes and the method of auditory stimulation was explained, which includes reading a lullaby in the mother's own dialect. will be At 8 o'clock in the morning, the amount of milk prescribed by the doctor is poured into the syringe (SUPA) and given to the baby through the mouth by the researcher, and the amount of cc per minute is recorded, as well as the physiological indicators (heart rate, breathing rate and blood oxygen saturation percentage) It is measured by monitoring with the SAADAT brand, whose probe is attached to the baby's right hand. In the next step, at 10 o'clock in the morning, the mother will be present at the baby's bedside, for three minutes, a lullaby for baby, immediately after the intervention of the milk amount. The order given by the doctor was poured into the syringe and given to the baby through the mouth by the researcher, and the amount of cc per minute is recorded and the physiological indicators are also measured. If the patient is included in the tactile stimulation intervention group, first the demographic questionnaire form will be completed by the researcher and an individual training session will be held for the mother of the baby for 30 to 45 minutes and how to perform the tactile stimulation that is taught to the mothers in such a way that first they must disinfect their hands with an antibacterial solution, after warming the hand under the warmer, place one hand in a cup shape around the baby's head above the eyebrow line and place the other hand on the lower abdomen around the baby's waist and hips. The hands should be placed gently on the baby's body and only the hand should be in contact with the baby and no pressure should be applied to the baby's body. At 8 o'clock in the morning, the amount of milk ordered by the doctor is poured into the syringe (SUPA) and is given to the baby through the mouth by the researcher , and the amount of cc per minute is recorded, the physiological indicators (heart rate and breathing rate and percentage blood oxygen saturation is measured by monitoring with SAADAT brand, whose probe is attached to the baby's right hand. In the next step, the mother is present at the baby's bedside at 9:45 a.m., and she is asked to perform tactile stimulation for 15 minutes. Then, at 10 o'clock, the amount of milk ordered by the doctor is poured into the syringe, it is given to the baby through the mouth, and the amount of cc per minute is noted, and the physiological indicators are also measured. Control group: First, the demographic questionnaire form was completed by the researcher at 8 o'clock in the morning, after changing the diaper, the amount of milk ordered by the doctor was poured into the syringe and given to the baby through the mouth by the researcher, and the amount of cc per minute was noted. Physiological indicators are also measured. The infants of this group do not receive any intervention except for routine care according to the hospital's policy, again at 10 o'clock nutrition adequacy and physiological indicators are measured by the researcher. Nutritional adequacy: It is the amount of milk that the baby eats in the first ten minutes of feeding, which is calculated in milliliters per minute. Timepoint: Since the babies hospitalized in the intensive care unit are fed every two hours according to the doctor's order, for the post-test at 8:00 am after changing the diaper, the amount of milk ordered by the doctor was poured into the syringe and injected through the syringe. The mouth was given to the baby by a peso-stimulator and the amount was recorded in cc/min.Again, after the intervention (auditory or tactile) at 10 o'clock, the prescribed amount of breast milk was poured into the syringe and given to the baby through the mouth by the researcher, and the amount of cc per minute was recorded.The intervention will be carried out once a day in the morning shift for 3 days (on the fourth, fifth and sixth days of hospitalization). Method of measurement: The amount of milk that the baby eats in the first ten minutes of feeding, which is calculated in milliliters per minute. Physiological indicators (heart rate, breathing rate and blood oxygen saturation percentage) are measured by SAADAT brand monitoring whose probe is attached to the baby's right hand. Timepoint: At 8 am before the intervention and at 10 am after the intervention, physiological indicators are measured through monitoring. Method of measurement: Physiological indicators (heart rate and breathing rate and blood oxygen saturation percentage) are recorded and measured by monitoring with SAADAT brand whose probe will be attached to the baby's right hand. Zahedan University of Medical Sciences Approved 2023-06-18 Ethics Committee of Zahedan University of Medical Sciences Dr. Hasabi Square, Baluchistan Blvd, Zahedan University of Medical Sciences Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)