The study aimed to investigate the effect of fetal tucking compared to free posture of the body on premature infants sleep, Participants in this study of preterm infants with gestational age of 33-36 weeks and weighting more than 1500 gr admitted to the Al-Zahra medical center in Tabriz. To determine the sample size of the pilot study with 10 infants in each group (four groups) will take. These infant will be randomly assigned into four groups, One day with fetal tucking at right or left lateral position, one day with free posture at right or left lateral position, one day with fetal tucking at supine position and other day with free posture at supine position. Randomized to different states and positions of random permutations ABCD will be used, the infant was observed in four days and Sleep-wake states over a period of 24 hours will be recorded with a video camera. All participants will examine the effect of posture on the amount of sleep, maintaining the posture and position of the infant by four trained nurse will be. The videos recorded will analysis by two observers. Duration of sleep and wakefulness during 24 hours on the sleep Diagram scale will be recorded every five minutes, for the diagnosis of sleep-wake states from the state APIB scale will be used
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201407088315N9
Registration date:2014-08-12, 1393/05/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-12, 1393/05/21
Registrant information
Name
Leila Valizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 6770
Email address
valizadehl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-08-01, 1393/05/10
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the facilited tucking and free posture on sleep among premature infants hospitalized in neonatal wardstrial
Public title
the effect of the facilited tucking and free posture on premature infant sleep
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: gestational age 33-36 week; post birth age: from 2th day; birth weight more or equal 1500gr; NTISS less 21; No need to respiratory assistance; Do not have any congenital anomalies; hospitalized in neonatal ward; No contraindication to changes positions; do not SGA and IUGR; do not substance -abusing mother; No single dose of aminophylline and caffeine
exclusion criteria: neurologic impairment including convulsion, intraventricular hemorrhage grade 3 or 4; documented congenital infection; Need for surgery; severe medical conditions requiring treatments such as sedatives, muscle relaxants, antiepileptic, aminophylline, or analgesic drug; mother's unwillingness to continue the study; Need to perform various procedures; The use of pacifier; Lumber Puncher at infant
Age
From 2 days old to 1 month old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Nursing and Midwifery Faculty, South Shariati Ave
City
Tabriz
Postal code
5138947979
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
9358
Health conditions studied
1
Description of health condition studied
preterm infant
ICD-10 code
p07.1 - p0
ICD-10 code description
Disorders related to short gestation and low birth weight, not elsewhere classifiedOther low birth weight
Primary outcomes
1
Description
The amount of sleep in 24 hours
Timepoint
Calculate the amount of sleep for 24 hours for each group at the end of each period
Method of measurement
Sleep Diagram scale
Secondary outcomes
1
Description
State development (increasing infant sleep in 24 hour)
Timepoint
Calculate the amount of sleep for 24 hours for each group at the end of each period
Method of measurement
Sleep Diagram scale
Intervention groups
1
Description
One day with fetal tucking at right or left lateral position.The infant was observed in one days and Sleep-wake states over a period of 24 hours will be recorded with a video camera. All participants will examine the effect of posture on the amount of sleep, maintaining the posture and position of the infant by four trained nurse will be.
Category
Treatment - Other
2
Description
One day with free posture at right or left lateral position. The infant was observed in one days and Sleep-wake states over a period of 24 hours will be recorded with a video camera. All participants will examine the effect of posture on the amount of sleep, maintaining the posture and position of the infant by four trained nurse will be.
Category
Treatment - Other
3
Description
One day with fetal tucking at supine position. The infant was observed in one days and Sleep-wake states over a period of 24 hours will be recorded with a video camera. All participants will examine the effect of posture on the amount of sleep, maintaining the posture and position of the infant by four trained nurse will be.
Category
Treatment - Other
4
Description
One day with free posture at supine position. The infant was observed in one days and Sleep-wake states over a period of 24 hours will be recorded with a video camera. All participants will examine the effect of posture on the amount of sleep, maintaining the posture and position of the infant by four trained nurse will be.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational and Therapeutic Center Al-Zahra
Full name of responsible person
Leila Valizadeh
Street address
Al-Zahra Hospital, Bagh Shomal Cross, South Artesh Street, Tabriz
City
Tabriz
2
Recruitment center
Name of recruitment center
Educational and Therapeutic Center Al-Zahra
Full name of responsible person
Leila Valizadeh
Street address
Nursing and Midwifery Faculty, South Shariati Ave -
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Rashidi
Street address
Tabriz University of Medical Sciences, Golgasht Street, Azadi Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing and Midwifery Faculty
Full name of responsible person
Golnar Ghahremani
Position
Master Science Student of Neonatal Intensive Care
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, South Shariati Ave
City
Tabriz
Postal code
5138947977
Phone
+98 41 2332 2232
Fax
+98 47 52839
Email
golnar.gahramani@yahoo.com
Web page address
www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery Faculty
Full name of responsible person
Leila Valizadeh
Position
Professor assistant
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty, South Shariati Ave
City
Tabriz
Postal code
5138947977
Phone
+98 41 1479 6770
Fax
+98 47 52839
Email
valizadehl@tbzmed.ac.ir
Web page address
www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery Faculty
Full name of responsible person
Golnar Ghahremani
Position
Master Science Student of Neonatal Intensive Care
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty,South Shariati Ave
City
Tabriz
Postal code
5138947977
Phone
+98 41 2332 2232
Fax
+98 47 52839
Email
golnar.gahramani@yahoo.com
Web page address
www.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)