The Aim of this research, is the effect of nesting position on stress motor behaviors in preterm infants in the Neonatal Intensive Care Unit. This clinical trial is not blinded. By balanced blocked randomization, infants are put into control or intervention groups. Total of 44 stable preterm infants hospitalized in Neonatal Intensive Care Unit (NICU) in Hazrate Rasool hospital of Tehran University of Medical Science participate in the trial. Their gestational age is 30 weeks to 33 weeks 6 day, with birth weight between 1000 to 1500 gr. And without need to mechanical ventilation or prescription Phenobarbital or phenytoin till the end of the program. Intervention is putting the experimental infants in to the nest for one week. After taking informed consent from parents, the first day, they are filmed for 20 minutes without interruptions, when they rest in the incubator in prone position. Experimental group are put into the nest for seven days. The control group rest into the incubator without nest. After seven days they will be videotaped again. Total of stress motor behaviors will be counted in both groups, before and 7 days later. It is predictable that nesting position may reduce stress motor behaviors.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111298251N1
Registration date:2012-07-25, 1391/05/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-25, 1391/05/04
Registrant information
Name
Zahra Eskandari
Name of organization / entity
Tehran Nursing and Midwifery Faculty
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
z-eskandari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
NICU Master Thesis, with Nursing Research Center of Tehran University of Medical Science support
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of nesting position on stress motor behaviors in preterm infants
Public title
Effect of nesting position on stress
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Birth weight:1000-1500 gr.; Gestational age at birth of 30 weeks to 33 weeks 6 days(<34weeks) after mother's last menstrual period; Being in secondary week postnatal age; Resting into the incubator; absence of congenital or chromosomal abnormality, IUGR, or other anomalies like clavicle fracture, hip or limb deformities.
exclusion criteria: substance abuse in mothers; Intra ventricular hemorrhage(3 ,4 degree)that recognized by brain ultrasound; Sepsis; NPO, any invasive ventilation, prescription Phenobarbital or phenytoin till end of the program.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Science
Street address
Research Center, Ghods Ave, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2012-06-09, 1391/03/20
Ethics committee reference number
55123
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
F43, F43.0
ICD-10 code description
F43:Reaction to severe stress, and adjustment disorders-F43.0 :Acute stress reaction
Primary outcomes
1
Description
Total stress motor behaviors
Timepoint
Befor intervention, One week after intervention
Method of measurement
Als's behavior observation(standard)
Secondary outcomes
empty
Intervention groups
1
Description
In evening shift of first day and before nesting position, the researcher videotapes behaviors for 20 minutes continued. Through recording, infant is in the incubator in prone position just with a diaper and small pad under the shoulder. The researcher records infants' posture and movements. Experimental group are put into the nest for seven days. Nests are oval shaped cloth with boundaries in both sides that also surrounds feet. It's size is chosen according to the infants weight. The positioning program through nesting will be taught to the nurses. Throughout this period, the infant can remove from the nest, for weighting, breastfeeding, bathing and other cares. After seven days nest is removed and 20 minutes recording of infants will be done, in such before. The researcher review the films for count and comparing total stress motor behaviors.
Category
Other
2
Description
In the control group, in the evening shift of first day, the researcher videotapes behaviors for 20 minutes continued. Through recording, infant has laid in the incubator in prone position and dressed in a diaper with small pad under the shoulder. The researcher records infants' posture and movements. One week later, they will be filmed in such before. In these seven days he/she will gain routine nursing cares. The researcher review the films for count and comparing total stress motor behaviors. The researcher review the films for count and comparing total stress motor behaviors.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Rasool Teaching Hospital
Full name of responsible person
Dr. Parisa Mohagheghi
Street address
Satar khan Ave, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Science
Full name of responsible person
Fateme Banazade
Street address
Research Center, Pursina Bldg, Ghods Ave, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?