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IRCT20200809048338N1 IRCT 2021-08-15 University of social welfare and rehabilitation sciences Effect of Vestibular Stimulation on motor performance and behavior of premature infants admitted at the Neonatal Intensive Care Unit. Designing a Vestibular Stimulation Package for preterm infants admitted at Neonatal Intensive Care Unit (NICU) and the effects of its implementation on motor performance and behavior of premature infants admitted at the NICU: A Single Blind Randomized Clinical Trial (RCT). 2021-08-23 anticipated 70 Complete https://irct.ir/trial/50200 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Simple consecutive random method will be used for sampling. The allocation sequence for concealment will be done by a non-research person (secretary) so that using a sealed envelope, infants will be placed in two groups receiving vestibular stimuli in addition to routine interventions and a group of routine interventions, Blinding description: In this study, the initial evaluation of motor performance and behavior of the infant as well as the final evaluation by the evaluator unaware of the process and how to intervene in the intervention and control groups will be done. N/A preterm infants. Intervention 1: Intervention group: Stimulations of the vestibular system in the form of Lateral movements, Anterior_Posterior movements, Up_Down movements and Rotational motions. Lateral movements (at a distance equivalent to one step of the mother to the sides about 30-35 cm) are right_left and left_right movements with a speed of 12-14 cycles / minute and then 30 seconds rest. Anterior_posterior movements (at a distance equal to one step forward about 30-35 cm) and with a speed of 12-14 cycles / minute then 30 seconds rest. Up-down movements (distance equal to 10-15 cm) and at a speed of 12-14 cycles / minute and then 30 seconds rest. Rotational motions are 2 clockwise and counterclockwise movements up to 180 degree in a row for 30 seconds (this step is repeated up to 3 times in a row) at a speed of 10 cycles / minute, i.e. 6 movements in 1 minute and Twice they will rest for 30 seconds between interventions. Intervention 2: Control group: Routine interventions in the Neonatal Intensive Care Unit. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: Access period starts 6 months after the results are published. To whom: Researchers working in academic and scientific institutions. Conditions: For further researches Where to obtain: call 00989122633687 How to obtain: about one week. Comments:
public Aida Ravarian
Kodakyar Ave., Daneshjo Blvd., Evin
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2204 1198 a.ravarian@gmail.com University of social welfare and rehabilitation sciences scientific Aida Ravarian
Kodakyar Ave., Daneshjo Blvd.,Evin
Tehran Iran (Islamic Republic of) 1985713871 +98 21 2204 1198 a.ravarian@gmail.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Parents' desire for their infants to participate in the study. Fetal age is 34 weeks of gestation or less. Living in Tehran province. 3 days no limit Both Neonates who need surgery during hospitalization. Neonates with hydrocephalus. Neonates with moderate to severe brain damage, such as grade III to IV interventricular hemorrhage. Neonates with grade III or higher premature retinopathy. Neonates with untouchable skin. Neonates with severe respiratory problems (require FiO2 above 75%). Neonates with severe congenital anomalies. Neonates with tachycardia (rapid heartbeat) and bradycardia (slow heartbeat). Neonates who look unstable. Multiple pregnancy. Existence of physical and psychological illness of the mother that has created a disability for the mother. Mother with a history of HIV. Existence of symptoms of infant syndrome. Rehabilitation Treatment - Other Intervention group: Stimulations of the vestibular system in the form of Lateral movements, Anterior_Posterior movements, Up_Down movements and Rotational motions. Lateral movements (at a distance equivalent to one step of the mother to the sides about 30-35 cm) are right_left and left_right movements with a speed of 12-14 cycles / minute and then 30 seconds rest. Anterior_posterior movements (at a distance equal to one step forward about 30-35 cm) and with a speed of 12-14 cycles / minute then 30 seconds rest. Up-down movements (distance equal to 10-15 cm) and at a speed of 12-14 cycles / minute and then 30 seconds rest. Rotational motions are 2 clockwise and counterclockwise movements up to 180 degree in a row for 30 seconds (this step is repeated up to 3 times in a row) at a speed of 10 cycles / minute, i.e. 6 movements in 1 minute and Twice they will rest for 30 seconds between interventions. Control group: Routine interventions in the Neonatal Intensive Care Unit. Motor performance. Timepoint: At the beginning of the study (before the start of the study) and one week after the start of the intervention. Method of measurement: How to measure motor performance is the Test of Infant Motor performance. Behavior. Timepoint: At the beginning of the study (before the start of the study) and one week after the start of the intervention. Method of measurement: How to measure the neonate's behavior will be through the Nidcap test. University of social welfare and rehabilitation sciences Approved 2020-10-25 Ethics committee of University of Social Welfare and Rehabilitation Sciences Kodakyar Ave., Daneshjo Blvd., Evin Tehran Tehran Iran (Islamic Republic of)