The effect of concurrent use of swaddle and sucrose taste on the Intensity of pain During Venous Blood sampling in Neonate: A clinical trial Study

Determining the effect of concomitant use of sucrose and swaddling during blood sampling on pain intensity in infants

Clinical trial, with control group, double-blind, randomized and random allocation based on a sequence generated by computer software and will be performed by random block method to size 4.

Setting: Neonatal ward of Amirkola Hospital in Babol Methods: In the intervention groups, the use of sucrose and swaddle will start 2 minutes before blood sampling and will be maintained during blood sampling. the use of sucrose and swaddle will continue up to 2 minutes after blood sampling. None of interventions will be used in the control group.

Term neonates with a gestational age of 37-42 weeks - Stability of vital signs before sampling - No congenital or genetic abnormalities - No use of drugs, antidepressants and anticonvulsants by the mother during pregnancy- No surgery and receiving anesthesia drugs 6- No intubation

Infants are randomly assigned to each of the four groups of "sucrose", "swaddle", "sucrose swaddle" and also "control group".

Intensity of pain during venous blood sampling in premature infants

After applying the Inclusion and exclusion criteria the method of assigning the subjects will be random allocation by permutation block method. Randomizing is at individual level. The size of the blocks is 4 and in each block, each intervention group will be repeated once. As a result, we will have 24 different blocks, each of which will be numbered from 1 to 24 as desired. Then, using the statistical program code rdunif (n=15, b=24, a=1) in R software version 3.6.1, 15 blocks of 4 will be generated, which will produce a total of 60 sequences (It should be noted that this code generates 15 random numbers from the numbers 1 to 24, which are the number of blocks). Using this randomly generated list, infants will be placed in the "sucrose", "swaddle", "sucrose swaddle", and "control" groups. To hide the random allocation list, a special code will be assigned to each of the intervention groups that only the executor of plan is aware of. These codes are written on a piece of paper and placed in a sealed envelope. A unique code for each patient will be written on this paper as well as its envelope. A foil is also placed inside each envelope so that the envelopes are not legible under light. Each envelope also contains a white paper and a carbon. All envelopes are randomly placed in a larger box and sealed in the box. The main researcher, after reviewing the inclusion criteria and obtaining informed consent, as well as registering the patient's details in a special form, will contact the partner who has a random assignment list (except for the main researcher who is not involved in the patient recruitment and sample entry process) and randomization of that research sample will be done. Also, before opening the envelope, this person should write the name and surname and age of the person on the place marked on the envelope so that the writing falls on the paper inside the envelope.

Intervention groups are infants on whom blood sampling is performed. Infants are unaware of the effects of sucrose and swaddle and are actually blind to the purpose of the study. The analyzer is not aware of the intervention groups and therefore has no bias in interpreting the data.

The data will be provided to the interested parties in an encoded form in Excel format, taking into account ethical considerations.

After completing the study

Everyone

After the publication of the article, all analyzes on the data are allowed by all interested people

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