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IRCT20200913048704N2 IRCT 2021-07-13 Babol University of Medical Sciences 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 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 2021-08-03 anticipated 60 Complete https://irct.ir/trial/57406 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: 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, Blinding description: 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. N/A Intensity of pain During Venous Blood sampling in Preterm Neonates. Intervention 1: Intervention group: Sucrose group: Infants who receive 24%sucrose from 2 minutes before injection to 2 minutes after injection. In this group, the standard 24%sucrose, 0/2 ml / kg is used with a 1 ml syringe without a needle. Intervention 2: Intervention group: Swaddle group: Infants who are swaddled from 2 minutes before injection to 2 minutes after injection. Infants without clothes and with only one diaper, swaddle on a triangular cloth. Intervention 3: Intervention group: Swaddle sucrose group: Infants who become both receive sucrose and swaddle from 2 minutes before injection to 2 minutes after injection. Intervention 4: Control group: Control group: Infants who do not receive any of the interventions. Yes - There is a plan to make this available What will be shared: The data will be provided to the interested parties in an encoded form in Excel format, taking into account ethical considerations. When: After completing the study To whom: Everyone Conditions: After the publication of the article, all analyzes on the data are allowed by all interested people Where to obtain: Correspond Author How to obtain: By sending an email Comments:
public Ali Zabihi
Babol University of Medical Sciences, Ganjafrooz Street
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 0595 zabihi_alii@yahoo.com Babol University of Medical Sciences scientific Ali Zabihi
Babol University of Medical Sciences, Ganjafrooz Street
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 0595 zabihi_alii@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Term infants with a gestational age of 42-37 weeks Stability of vital signs before sampling No congenital or genetic abnormalities Non-use of drugs, antidepressants and anticonvulsants by the mother during pregnancy No surgery and receiving anesthesia and anesthesia drugs Lack of intubation 1 day 28 days Both Abnormalities in the head and skull such as cleft lip and palate and atrial fibrillation Infants who experience more than grade II intraventricular hemorrhage during the study. Prevention Prevention Prevention Prevention Intervention group: Sucrose group: Infants who receive 24%sucrose from 2 minutes before injection to 2 minutes after injection. In this group, the standard 24%sucrose, 0/2 ml / kg is used with a 1 ml syringe without a needle. Intervention group: Swaddle group: Infants who are swaddled from 2 minutes before injection to 2 minutes after injection. Infants without clothes and with only one diaper, swaddle on a triangular cloth. Intervention group: Swaddle sucrose group: Infants who become both receive sucrose and swaddle from 2 minutes before injection to 2 minutes after injection. Control group: Control group: Infants who do not receive any of the interventions. Intensity of pain during venous blood sampling in preterm infants. Timepoint: 2 minutes before, during and 2 minutes after blood sampling. Method of measurement: Neonatal Infant Pain Scale. Infant heart rate changes 15 minutes before, during and 15 minutes after intravenous sampling. Timepoint: 2 minutes before, during and 2 minutes after intravenous sampling. Method of measurement: Cardiorespiratory monitoring device. Babol University of Medical Sciences Approved 2020-08-10 Ethics committee of Babol University of Medical Sciences University of Medical Sciences , Ganjafrooz Street , Babol , Mazandaran ,Iran Babol Mazandaran Iran (Islamic Republic of)