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IRCT20201007048967N1 IRCT 2020-12-20 Mashhad University of Medical Sciences The effect of positioning with an octopus doll on the behavioral responses of premature infants under non-invasive ventilation The effect of positioning with an octopus doll on the behavioral responses of premature infants under non-invasive ventilation 2020-10-23 anticipated 25 Complete https://irct.ir/trial/51559 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Supportive, Randomization description: Samples will be randomly assigned to two groups using the envelope method. This is how the envelopes will be prepared and printed by one of the members of the research team and random numbers with the help of Randomaize.com site and will be placed inside the envelope. The lid of the envelope will be closed and its contents will not be visible from the outside. Then, the purpose of the study is first explained to the infant's parents, and if they wish, they sign the informed consent form and take an envelope, and then open it, and based on the contents of the envelope, the infant enters the intervention or control group, Blinding description: In this study, the subjects under study who are premature infants are not aware of the study and also the analyst will be unaware of the intervention and control groups. N/A behavioral responses of premature infants. Intervention 1: Intervention group: The infants of the first group will be placed in the fetal position for the first 2 hours and then in the second 2 hours they will be placed in the fetal position with the touch of an octopus doll. In this study, the octopus doll is placed in the baby's arms and the doll's feet are placed in contact with the baby's body and hands. And the interventions will be repeated for 3 consecutive days in a fixed evening shift. Intervention 2: Control group: In the infants of the second group, they will be in contact with the doll in the first 2 hours and the doll will be removed from the baby in the second 2 hours. For the wash out phase, the babies will be in a supine position for 2 hours. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after unidentified individuals. When: The start of the access period is 2 months after the results are published. To whom: The data will be made available to researchers working in academic and scientific institutions and to people in the relevant industry and to the relevant ministry. Conditions: If this study has a positive effect, the effect of touching an octopus doll on the behavioral response of a premature infant under non-invasive ventilation can be used as a useful and acceptable solution to reduce stress and help calm the infant in the neonatal intensive care unit. As a result, increased relaxation is the most important element in the development of the premature nervous system. Where to obtain: Kimia Razi: razik961@mums.ac.ir Phone: 09156516202 Hamidreza Behnam Vashani: behnamhr@mums.ac.ir Phone: 09151109514 How to obtain: The applicant must communicate via the contact number and e-mail address provided. Comments:
public Kimia Razi
School of Nursing and Midwifery., Ibn Sina St, Ph.D. Intersection., Daneshgah St, Mashhad, Khorasan Razavi.
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 razik961@mums.ac.ir Mashhad University of Medical Sciences scientific kimia Razi
School of Nursing and Midwifery., Ibn Sina St, Ph.D. Intersection., Daneshgah St, Mashhad, Khorasan Razavi.
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 razik961@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Guardian parent's consent for the infant to participate in the study infant age in the range of 28 to 34 weeks (based on LMP or sonography of the first trimester of pregnancy) under non-invasive ventilation maximum 24 hours after the start of non-invasive ventilation No invasive procedure was performed on the infant 2 hours before admission to the study no contraindications to change position no drug use in the mother during pregnancy and postpartum no use of drugs that affect the sleep and wake cycle of the baby such as theophylline, phenobarbital lack Prescribing sedatives such as midazolam and fentanyl Having an Apgar score of 5 minutes above 6 no surgery on the infant after birth 7 months 8 months Both Congenital and chromosomal abnormalities asphyxia intracerebral hemorrhage more than first grade sepsis heart disease metabolic disease anemia SGA and IUGR P07.3 preterm infants N/A N/A Intervention group: The infants of the first group will be placed in the fetal position for the first 2 hours and then in the second 2 hours they will be placed in the fetal position with the touch of an octopus doll. In this study, the octopus doll is placed in the baby's arms and the doll's feet are placed in contact with the baby's body and hands. And the interventions will be repeated for 3 consecutive days in a fixed evening shift. Control group: In the infants of the second group, they will be in contact with the doll in the first 2 hours and the doll will be removed from the baby in the second 2 hours. For the wash out phase, the babies will be in a supine position for 2 hours. Behavioral response of premature infants (sleep, wakefulness and restlessness). Timepoint: Behavioral reactions of premature infants will be observed 2 minutes before the intervention, 2 minutes during and 2 minutes after the intervention and in each turn will be observed for 30 seconds and will be recorded in the relevant form. Method of measurement: In this study, the infant's behavioral response is assessed using the Anderson Behavioral Reaction Scoring System (ABSS), which measures the infant's behavior with sleep, wakefulness, and restlessness. This scoring system determines a baby's behavioral status based on observation of respiratory order, open or closed eyes, trunk and limb activity, and crying intensity. The scoring system consists of 12 levels and behavioral states are classified into three categories: sleep, wakefulness, and restlessness. The scores are 1-5 related to sleep, 6-8 points related to wakefulness and rest, and 9-12 points related to restlessness. Based on this ABSS tool, 2 minutes before, 2 minutes during and 2 minutes after the intervention and at each turn for 30 seconds, the reactions of the baby's behaviors will be observed and recorded in the relevant form. In the Anderson Behavior Scoring System, the infant is observed for 30 seconds and the number corresponding to the highest behavioral state observed is recorded with one exception: Conscious Inactivity, which is a desirable but relatively rare state when it occurs. It is possible even if another state with the highest number occurs in the same 30 seconds, because conscious inactivity is a desirable state in infants. . Timepoint: . Method of measurement: . . Timepoint: . Method of measurement: . Mashhad University of Medical Sciences Approved 2020-08-03 Ethics Committee in Research School of Nursing and Midwifery - Mashhad University of Medical Science School of Nursing and Midwifery., Ibn Sina St, Ph.D. Intersection., Daneshgah St, Mashhad, Khorasan Razavi Mashhad Razavi Khorasan Iran (Islamic Republic of)