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IRCT20230709058729N1 IRCT 2023-07-13 Mashhad University of Medical Sciences " the Effect of the White noise on Behavioral Responses of Premature Infants" "the Effect Sound reduction on Behavioral Responses of Premature Infants " Comparison the Effect of the White noise and Sound reduction on Behavioral Responses of Premature Infants under Non-invasive Ventilation 2023-07-22 anticipated 32 Complete https://irct.ir/trial/71255 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Blocked. { This method is used to prevent significant imbalances in the number of participants assigned to each group. Block randomization ensures that there is no significant imbalance between groups during randomization and at certain points the number of participants in each group is equal.Then write the list of blocks and assign numbers to them. ( AABB(1)- ABAB(2)-ABBA(3)-BBAA(4)- BABA(5)- BAAB(6)) .Then select random numbers between 1 to 6( for example 1 4 5 ...) and finally specify the treatment allocation list based on the previous random numbers ( … AABB-BBAA-BABA-) .}, Blinding description: Participants are premature infants and consent is obtained from their parents, so infants are unaware and are blind. The analyst is a statistical consultant who analyzes the data collected during the study. N/A behavioral responses of premature infants. Intervention 1: Intervention group: This study is a randomized clinical trial with cross-sectional design. The cross design used in this study is standard cross design 2x2 BA/AB). 32 preterm infants in the range of 28-36 weeks will be included in the study under non-invasive ventilation in NICU of Hakim Hospital of Neyshabur who meet the inclusion criteria.Behavioral responses of preterm infants will be assessed and recorded 2 minutes before intervention, 2 minutes during and 2 minutes after intervention using Anderson's Behavioral Response Scoring System (ABSS). It should be noted that the time to observe and evaluate the behavior of the infant is 30 seconds at each stage. Intervention 2: Control group: In standard crossover design (BA/AB 2 x2), the infants in the intervention group are self-control. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is "There is no more information."
public Mahdieh Mohseni kakhki
Mashhad Faculty of medical scienses ,chaharrah doctora street
Mashhad Iran (Islamic Republic of) 9183793577 +98 51 3859 1511 mohsenikm4012@mums.ac.ir Mashhad University of Medical Sciences scientific Monir Ramezani Farmad
doctor Crossroads (Intersection of Ibn Sina Street and Daneshgah)
Mashhad Iran (Islamic Republic of) 9183793577 +98 51 3859 1511 Ramezanimn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Parental Consent for Infant Participation in Research The baby's age ranges from 28 to 36 weeks and 6 days (based on LMP or ultrasound) Be under non-invasive ventilation and have not been at most 24 hours since the onset of non-invasive ventilation No invasive action was taken on the infant 2 hours before entering the study. Normality of OAE test No Counter-Indication to Change Positions Lack of drug use in the mother during pregnancy and after childbirth Not taking medications that affect the baby's sleep-wake cycle, such as theophylline, phenobarbital Lack of sedatives such as midazolam and fentanyl Absence of congenital abnormalities such as meningocele and meningomyelocele, meningitis, seizures, encephalopathy, congenital anomalies, asphyxia, intracranial hemorrhage greater than first-degree, sepsis, heart disease, metabolic and anemia. The baby is not SGA or IUGR. Having an Apgar score of 5 minutes above 6 Surgery on the baby after birth. 28 days 36 days Both Poor baby (loss of consciousness, spo2 drop and change of vital signs from normal range) Dissatisfaction of the parent of the guardian to the continuation of the infant's participation in the research Infant death during the study Infant Transfer Need for invasive procedures during intervention Prescription of sedative drugs during intervention Developing neurological disorders such as seizures, grade 3 and 4 ventricular bleeding, sepsis Need for surgery Severe medical conditions that require the use of treatments such as sedatives, muscle relaxants, and analgesic medications Performing LP in baby Inappropriate medical condition, such as an unstable clinical condition Need for surgery Behavior Behavior Intervention group: This study is a randomized clinical trial with cross-sectional design. The cross design used in this study is standard cross design 2x2 BA/AB). 32 preterm infants in the range of 28-36 weeks will be included in the study under non-invasive ventilation in NICU of Hakim Hospital of Neyshabur who meet the inclusion criteria.Behavioral responses of preterm infants will be assessed and recorded 2 minutes before intervention, 2 minutes during and 2 minutes after intervention using Anderson's Behavioral Response Scoring System (ABSS). It should be noted that the time to observe and evaluate the behavior of the infant is 30 seconds at each stage. Control group: In standard crossover design (BA/AB 2 x2), the infants in the intervention group are self-control Behavioral response score of premature infant. Timepoint: Behavioral response score of preterm infant 2 minutes before, during and 2 minutes after intervention. Method of measurement: Infant Behavioral Reactions Registration Form Using Anderson Behavioral Response Scoring System (ABSS). Mashhad University of Medical Sciences Approved 2023-07-07 Ethics committee of Mashhad University of Medical Sciences Faculty of Nursing and Midwifery located at the intersection of Doctora (Ibn Sina St. and University) Mashhad Razavi Khorasan Iran (Islamic Republic of)