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Effects of inviromental and behaivire intervention on the sleep cycle of newborne hospitalized

Protocol summary

Study aim
A comparison between effect of environmental and behavioral Intervention on sleep cycle of infants in NICU
Design
In this prospective crossover clinical trial, 40 preterm infants with fetal age of 32 to 36 weeks Infants randomly divide into two groups include environmental-behavioral intervention and behavioral -environmental intervention. Then each course of study includes: control course, first intervention and second intervention have held in 2 hours.
Settings and conduct
this study is prospective crossover clinical trial. Sampling was from July 22nd, 2016 to December 21st, 2016 in Alzahra Institute dependent on Isfahan University of Medical Science.
Participants/Inclusion and exclusion criteria
Fetal age 32 to 24 weeks , neonatal age of 1-20 days, self-breathing without support, no congenital defect and no abnormal neurologic finding , no usage of addictive drugs by mother in pregnancy, no sedative therapy in last 24 hours, impossible to do kangaroo mother care or limitation to use it or mother unwilling or absence, no diarrhea, no infant rehospitalization, APGAR>4 , every 2 hours feeding
Intervention groups
Environmental intervention : in Environmental intervention course, we decrease the light and turn off extra lamps and noises reduce by inserting earplugs in infant’s ears. behavioral intervention: In behavioral intervention course, we make a fetal position for infants by ward tools and Avoiding any not necessary manipulation.
Main outcome variables
three different courses has significant differences in time of sleep.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171106037282N2
Registration date: 2018-06-25, 1397/04/04
Registration timing: retrospective

Last update: 2018-06-25, 1397/04/04
Update count: 0
Registration date
2018-06-25, 1397/04/04
Registrant information
Name
samira karami
Name of organization / entity
Isfahan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5224 4786
Email address
samirakarami60@gmail.com
Recruitment status
Recruitment complete
Funding source
institution
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-02-22, 1395/12/04
Actual recruitment start date
2016-07-22, 1395/05/01
Actual recruitment end date
2017-02-22, 1395/12/04
Trial completion date
empty
Scientific title
Effects of inviromental and behaivire intervention on the sleep cycle of newborne hospitalized
Public title
Effects of inviromental and behaivire intervention on the sleep cycle of newborne hospitalized
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Fetal age 32 to 24 weeks base on mother LMP or ultrasound, self-breathing without support no congenital defect and no abnormal neurologic finding include intraventricular hemorrhage (more than grade 2) no sedative therapy in last 24 hours no usage of addictive drugs by mother in pregnancy,, impossible to do kangaroo mother care or limitation to use it or mother unwilling or absence, no diarrhea, no infant rehospitalization, APGAR>4 every 2 hours feeding neonatal age of 1-20 days
Exclusion criteria:
necessary need to do special intervention during study parents refuse to continue the study.
Age
From 1 day old to 20 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
N/A
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
Ethics committee Isfahan University of Medical Sciences
Street address
Faculty of Nursing &Midwifery Hezarjereeb Avenue,
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Approval date
2017-01-16, 1395/10/27
Ethics committee reference number
IR.MUI.REC.1395.3.953

Health conditions studied

1

Description of health condition studied
comparison between effect of environmental and behavioral Intervention on sleep cycle of infants
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
comparison sleep cycle of infants
Timepoint
6 hours
Method of measurement
Pertchl Scale

Secondary outcomes

empty

Intervention groups

1

Description
behavioral intervention course, we made a fetal position for infants by ward tools and Avoiding any not necessary manipulation
Category
Behavior

2

Description
in Environmental intervention course, we decrease the light and turn off extra lamps and noises reduce by inserting earplugs in infant’s ears.
Category
Other

3

Description
no interventions
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Rahmani Manesh
Street address
Sofe Ave,Alzahra Hospital
City
Isfahan
Province
Isfehan
Postal code
8478167617
Phone
+98 31 3668 5555
Email
samirakarami60@gmail.com
Web page address
http://alzahra.mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Kohan shahnaz
Street address
Faculty of Nursing &Midwifery، Hezarjereeb Avenue
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3668 7153
Email
esfahan@nm.mui.ac.ir
Web page address
Grant name
--------
Grant code / Reference number
395953
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Samira karami
Position
Graduate level
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Shohada Ave, Chamgordan Town, Esfahan
City
lenjan
Province
Isfehan
Postal code
8478167617
Phone
+98 31 5224 4786
Fax
+98 31 5224 4786
Email
samirakarami60@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Marofi
Position
Graduate level
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Jaber street,Mardavig Ave, Esfahan Town
City
Esfahan
Province
Isfehan
Postal code
8478167617
Phone
+98 31 3668 6889
Fax
Email
marofi@nm.mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Samira Karami
Position
Graduate level
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Chamgordan, Shohada Ave
City
Esfahan
Province
Isfehan
Postal code
8478167617
Phone
+98 31 5224 4786
Fax
Email
samirakarami60@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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