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IRCT20190520043648N1 IRCT 2019-07-04 Rasht University of Medical Sciences Effect of Hearing Simulated Intrauterine Sound on the Behavioral and Physiological Indicators of pain due to Blood Sampling in Preterm Infants Effect of Hearing Simulated Intrauterine Sound on the Behavioral and Physiological Indicators of pain due to Blood Sampling in Preterm Infants 2019-06-22 anticipated 80 Complete https://irct.ir/trial/39739 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Available samples are randomly assigned to two groups using the method of placing random blocks.In this way, the samples will be placed in one of the two intervention and control groups by random allocation method with four blocks.In this regard, it is initially assigned to the intervention group letter A and to control group the letter B.Then, 6 different modes, and the possibility of placing these two letters in blocks of four, including ABBA, ABAB, BAAB, BABA, BBAA, AABB, will be recorded in separate sheets. To create sequences after registering 6 different modes and possible, to place two letters A and B in the four blocks including ABBA, ABAB, BAAB, BABA, BBAA, AABB, and the placement of each letter in separate sheets, in the next step after the notes written inside a dish will be placed.Using a lottery, randomly, each time a sheet of paper is removed from the dish and the letters are written down accordingly, and the sheet is returned to the dish again.Frequency of the lottery will be 20 times according to the sample size of 80 neonates in two groups.Each time, the letters on the sheet are removed and will be added in the same order as the preceding letters.To create random allocation , the following software can also be used: Random allocation software . Next step ,in order to hide from the sealed envelopes will be used.In such a way that each of the designated letters,a number is assigned to the number of Specified sample size.The desired 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 and control group is such that by selecting each neonate who has the criteria for entering the study, one of these envelopes is respectively the number on the envelope opened and the letter in the envelope indicates which neonate should be in which of the groups.Random allocation process will be conducted by one researcher who is not involved in the selection of participants and their assignment to the test group, Blinding description: The participant (neonate)does not know which of the two intervention or control groups belongs. In order to observe Blindness at the time of data analysis and the uncertainty of intervention and control groups during video record, it is done with a close-up of the face and body of the neonate.The purpose of this record is accurate and clear the movements of the face and limbs of the neonate.Note that the relevant sound player and loudspeaker device is not visible inside the film.And so the sound of the videos is also cut off after the record.At the end of the work, visiting the films and completing the checklist of behavioral and physiological indicators of pain will be done by one of the researchers who is not present at the time of sampling and does not know the random allocation and as well as the type of groups. N/A behavioral and physiological Indicators of pain. Intervention 1: Intervention group:In the present study,Intrauterine simulated sound will be provided with medical educational software for intrauterine sound.This sound contains a relaxed Intrauterine sound simulated which is close to the real Intrauterine sounds. The intensity of the with a standard calibrated sound meter Device Benetech GM1351 will be adjusted to 45dB.The intervention method is that in the test group, each neonate will listen to this sound, 5 minutes before blood sampling, during and 5 minutes after intervention.The neonate will be in ancubator.And the temperature of the ancubator will be adjusted from 30 to 32 degrees.A portable speakers with external memory capacity of the TG 501 will be placed inside the ancubator.To perform blood sampling, the nurse disinfects the infant's limbs (the side of the foot) with alcohol cotton and uses a special needle for the premature infants.From the neonate inside the ancubator In supine position from the left side of the foot, blood sampling is done. Intervention 2: Control group:The control group will receive the usual care. No - There is not a plan to make this available Justification or reason for not sharing IPD is privacy of the data
public Shamime Yarahmadi
Gilan Blvd,Golsar Ave.Rasht city
Rasht Iran (Islamic Republic of) 41669-14555 +98 13 3377 3366 Yarahmadi.shamim@gmail.com Rasht University of Medical Sciences scientific Moluk Pouralizadeh‏
Shahid Beheshti school of nursing and Midwifery of Rasht
Rasht Iran (Islamic Republic of) 4146939841 +98 133355058 Pouralizadeh@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Premature Infants Aged 28 to 36 Weeks Weight less than 2500 grams Chronological Age is Less than one Week Physiological Stability (heart rate less than 160 beats per minute, less than 60 breaths per minute. Arterial oxygen saturation greater than 85%) First Minute apgar and fifth minute apgar ≥ 7 more than 30 minutes passed from the last feed Positive Moro Reflex 1 day 6 days Both History of intubation Use of analgesic or relaxing drugs and anticonvulsant during the last 24 hours Having intraventricular hemorrhage or leukomalacia Having any genetic abnormalities and any neurological disorder Shaking and touching the neonate during blood sampling by the mothers Within 4 hours before the intervention, any painful intervention or analgesic medication or other pharmacological or Non-pharmacological intervention has been performed Mother addiction The presence of any acute or chronic disease before or during pregnancy of the mother (such as heart disease and diabetes, preeclampsia, history of depression, etc.) Receiving any narcotic drug during and after delivery(In lactating mothers) Z00.12 Encounter for routine child health examination Other Other Intervention group:In the present study,Intrauterine simulated sound will be provided with medical educational software for intrauterine sound.This sound contains a relaxed Intrauterine sound simulated which is close to the real Intrauterine sounds. The intensity of the with a standard calibrated sound meter Device Benetech GM1351 will be adjusted to 45dB.The intervention method is that in the test group, each neonate will listen to this sound, 5 minutes before blood sampling, during and 5 minutes after intervention.The neonate will be in ancubator.And the temperature of the ancubator will be adjusted from 30 to 32 degrees.A portable speakers with external memory capacity of the TG 501 will be placed inside the ancubator.To perform blood sampling, the nurse disinfects the infant's limbs (the side of the foot) with alcohol cotton and uses a special needle for the premature infants.From the neonate inside the ancubator In supine position from the left side of the foot, blood sampling is done. Control group:The control group will receive the usual care Pain level in the Neonatal Infant Pain Scale (NIPS) Behavioral checklist. Timepoint: The researcher will filming neonatal behavioral changes with a video camera each time for 1 minute in 3 steps, including 5 minutes before and after intervention, during which time (during blood sampling time) and 5 minutes after the completion of blood sampling. Method of measurement: Neonatal Infant Pain Scale (NIPS) Behavioral checklist. Mean score of physiological indices including heart rate and hemoglobin saturation from oxygen. Timepoint: Each time for 1 minute in 3 steps including 5 minutes before and after the intervention, during it (during the bleeding time) and 5 minutes after the completion of blood sampling. Method of measurement: For measuring physiological parameters of pain including heart rate and hemoglobin saturation of oxygen, a calibrate pulse oximetry device, the model NOVAMETRIX will be used. Rasht University of Medical Sciences Approved 2019-05-11 Ethical Committee of Guilan University of Medical Sciences Opposite the 17 Shahrivar hospital,shahid siadati street,Namjoo street Rasht Guilan Iran (Islamic Republic of)