Effect of Hearing Simulated Intrauterine Sound on the Behavioral and Physiological Indicators of pain due to Blood Sampling in Preterm Infants

Determination the Effect of Hearing simulated intrauterine sound on the behavioral and physiological Indicators of pain due to blood sampling in preterm infant

Clinical trial with control group,With parallel groups,design of 80 patients ,Double blind, randomized

Al-Zahra educational-thrapeutic Center of rasht city in Guilan University of Medical Sciences in Neonatal and Neonatal intensive care unit.

Premature infants aged 28 to 36 weeks, Weight less than 2500 grams,Chronological age less than a 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,No history of intubation,No use of soothing or relaxing drug and anticonvulsant during the last 24 hours, Not having intraventricular hemorrhage or leukomalacia,The absence of any genetic abnormalities and any neurological disorder,Positive Moro Reflex

In the intervention group, each newborn will listen to the sound for 5 minutes before sampling from heel , during and 5 minutes after the intervention. In the control group, the newborns will not receive any additional interventions during Sampling from the heel

Neonatal Pain Behavioral indicators, physiological indicators of Pain including heart rate and hemoglobin saturation from oxygen

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.

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.

privacy of the data

The research report will be sent to deputy of research and technology of Guilan University of Medical Sciences

March 2020

The managers of neonatal hospitals and the related policymakers

Descriptive analysis

To deputy of research and technology of Guilan University of Medical Sciences

To deputy of research and technology of Guilan University of Medical Sciences

This is a proposal in form of Master of science in nursing. thank you so much