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IRCT2017011231892N1 IRCT 2017-09-24 Martyr Beheshti University of Medical Sciences The effect of environmental and behavioral interventions on physiological and behavioral responses of preterm infants candidate for intravenous catheterization in neonatal intensive care units The effect of environmental and behavioral interventions on physiological and behavioral responses of preterm infants candidate for intravenous catheterization in neonatal intensive care units 2017-02-19 anticipated 82 Complete https://irct.ir/trial/24974 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: Using colored beads. N/A Premature infants. Intervention 1: The intervention implemented in the experimental group: “environmental and behavioral interventions such as closing the infants’ eyes to reduce the light using eye pad, closing the infants’ ears to reduce auditory simulations using ear plugs and placing the baby in an embryonic state to reduce environmental simulations using the nests prepared by the researcher, are implemented by researcher. 30 minutes after intervention, while the intervention is going on, intravenous catheter placement is performed by a qualified nurse. At the same time, a nurse who knows how to fill out the measuring tools and has at least one year working experience in the neonatal ward, fills out the related checklist at the time of 2 minutes before, during and 5 minutes after intravenous catheter placement. Then, 30 minutes after intravenous catheter placement, while the intervention is going on, the physiologic information form and related checklists are filled out again and the infant is removed from the study after an hour.”. Intervention 2: The intervention implemented in the control group: “no environmental and behavioral interventions, except for routine cares, are implemented on the infants in the control group, but all the stages of collecting information and filling out the checklists are done and recorded like the first time.”.
public Shohreh Taheri Karchegani
School of Nursing and Midwifer, The intersection of prayer, Valiasr Street, The martyr Rajai Hospital Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 sbnmf@sbmu.ac.ir Martyr Beheshti University of Medical Sciences scientific Anahita Masoumpoor
School of Nursing and Midwifer, The intersection of prayer, Valiasr Street, The martyr Rajai Hospital Tehran, Iran
Tehran Iran (Islamic Republic of) 1985717443 +98 21 8865 5366 anahitakasra@yahoo.co.in Martyr Beheshti University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria; gestational age of 30-37 weeks;admission to neonatal intensive care unit; requiring administration of intravenous fluids and catheter; constant positive airways pressure (N-CPAP); no use of sedatives، anticonvulsants، or anesthetics; no comorbidities such as congenital abnormalities, neurological problems, or cerebral intra-ventricular hemorrhage and seizures and;fully conscious infant; Exclusion criteria; parents withdrawing participation of their infant; failure to insert intravenous catheter in two attempts; critical illness of infant in the process of its disease interfering with interventions; lack of response to N-CPAP . 1 day 1 day Both p07.3 28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation. Behavior Behavior The intervention implemented in the experimental group: “environmental and behavioral interventions such as closing the infants’ eyes to reduce the light using eye pad, closing the infants’ ears to reduce auditory simulations using ear plugs and placing the baby in an embryonic state to reduce environmental simulations using the nests prepared by the researcher, are implemented by researcher. 30 minutes after intervention, while the intervention is going on, intravenous catheter placement is performed by a qualified nurse. At the same time, a nurse who knows how to fill out the measuring tools and has at least one year working experience in the neonatal ward, fills out the related checklist at the time of 2 minutes before, during and 5 minutes after intravenous catheter placement. Then, 30 minutes after intravenous catheter placement, while the intervention is going on, the physiologic information form and related checklists are filled out again and the infant is removed from the study after an hour.” The intervention implemented in the control group: “no environmental and behavioral interventions, except for routine cares, are implemented on the infants in the control group, but all the stages of collecting information and filling out the checklists are done and recorded like the first time.” Physiological responses. Timepoint: 2 minutes before venipuncture, during venipuncture, 5 and 30 minutes after venipuncture. Method of measurement: Pulse monitoring, observation. Behavioral responses. Timepoint: 2 minutes before venipuncture, during catheter insertion, 5 and 30 minutes after venipuncture. Method of measurement: NIPS scale & EDIN scale. Martyr Beheshti University of Medical Sciences Approved 2016-11-13 Martyr Beheshti University of Medical Sciences Tehran, Vali Asr intersection of prayer, the Heart Hospital Rajai martyr, martyr Beheshti University of Medical Sciences Tehran Iran (Islamic Republic of)