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).
The effect of Vestibular Stimulations on motor performance and behavior of premature infants
Design
A clinical trial with a control group, one-sided blind, randomized, on 70 premature infants that using a simple consecutive random method by opening the sealed envelopes.
Settings and conduct
This research will be performed in Hazrate Rasoole Akram Hospital. After filling in the demographic information questionnaire and reviewing the inclusion and exclusion criteria, the infants who meet the inclusion criteria will be selected and the informed consent form will be filled in by the infant's parents. Infants who enter the study are evaluated by an blind assessor and
then they are randomly assigned to the intervention or control group. After the intervention period, the secondary evaluation will be performed again by the same evaluator.
Participants/Inclusion and exclusion criteria
Infants with a gestational age of 34 weeks or less who are in the normal range at birth and at 34 weeks of gestation age are stable in vital and physiological symptoms and have no specific underlying diseases can be included in the study.
Intervention groups
The control group benefits from routine services of the neonatal ward. The intervention group, in addition to having routine interventions in the neonatal ward, uses a designed package of vestibular stimuli. This package has been written by a group of experts in this field and is applicable and approved for premature infants.
Main outcome variables
Behavior and Motor Performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200809048338N1
Registration date:2021-08-15, 1400/05/24
Registration timing:prospective
Last update:2021-08-15, 1400/05/24
Update count:0
Registration date
2021-08-15, 1400/05/24
Registrant information
Name
Aida Ravarian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2204 1198
Email address
ai.ravarian@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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).
Public title
Effect of Vestibular Stimulation on motor performance and behavior of premature infants admitted at the Neonatal Intensive Care Unit.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Parents' desire for their infants to participate in the study.
Fetal age is 34 weeks of gestation or less.
Living in Tehran province.
Exclusion criteria:
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.
Age
From 3 days old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
Kodakyar Ave., Daneshjo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2020-10-25, 1399/08/04
Ethics committee reference number
IR.USWR.REC.1399.084
Health conditions studied
1
Description of health condition studied
preterm infants
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
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.
2
Description
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.
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
Control group: Routine interventions in the Neonatal Intensive Care Unit.