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IRCT20200913048704N3 IRCT 2023-03-25 Babol University of Medical Sciences The effect of combined non-pharmacological interventions on venous blood sampling pain in preterm infants: a clinical trial study The effect of combined non-pharmacological interventions on venous blood sampling pain in preterm infants: a clinical trial study 2023-04-29 anticipated 88 Complete https://irct.ir/trial/68628 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=22, b=24, a=1) in R software version 3.6.1, 22 blocks of 4 will be generated, which will produce a total of 88 sequences (It should be noted that this code generates 22 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 group, sucrose swaddle, sucrose non-nutritive sucking and sucrose swaddle non nutritive sucking group. 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, swaddle, and nonnutritive sucking and are actually blind to the purpose of the study. The analyzer is unaware of the intervention groups and therefore has no bias in interpreting the data. N/A Using non-pharmacological interventions to reduce the pain of newborns. Intervention 1: The first intervention group: Sucrose and non nutritive sucking combined group. Intervention 2: The second intervention group: the combined group of swaddling and sucrose. Intervention 3: The third intervention group: combined group of sucrose non nutritive sucking and swaddling. Intervention 4: Control group: sucrose group. 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: Anyone Conditions: After the publication of the article, all analyzes on the data are allowed by all interested people Where to obtain: People can contact the correspond Author by email to receive the article and data analysis. How to obtain: By Email: zabihi_alii@yahoo.com Comments:
public Ali Zabihi
Gangafrooz Street
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 0597 zabihi_alii@yahoo.com Babol University of Medical Sciences scientific Ali Zabihi
Gangafrooz Street
Babol Iran (Islamic Republic of) 47176-47745 +98 11 3219 0597 zabihi_alii@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Premature infants with a gestational age of 32 to 36 weeks and six days 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 Other Other Other Other The first intervention group: Sucrose and non nutritive sucking combined group The second intervention group: the combined group of swaddling and sucrose The third intervention group: combined group of sucrose non nutritive sucking and swaddling Control group: sucrose group Intensity of pain during venous blood sampling in infants. Timepoint: Before blood collection, during blood collection, 15 minutes after blood collection. Method of measurement: Premature infant pain profile. Physiological changes of newborns during and after venous blood sampling. Timepoint: Before the intervention, during the intervention and 15 minutes after the intervention. Method of measurement: Use of cardiorespiratory monitoring device. Babol University of Medical Sciences Approved 2023-02-06 Ethics committee of Babol University of Medical Sciences Gangafrooz Street Babol Mazandaran Iran (Islamic Republic of)