The aim of this study is to assess the effect of sound reduction management on preterm neonate’ stress in NICU.
Design
This study will done as a quasi experimental clinical trial with control & intervention group from same environment and sampling according to available samples with factorial groups & 90 samples and phase 3.
Settings and conduct
Current quasi experimental study will done in NICU1 of Therapeutic Complex of emam ALI in Alborz - Iran. Samples in intervention and control groups will choose from same ward.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Neonate without congenital abnormality on birth, gestational age 26-36 week and birth weight 1000-2500 gr.Neonate admit to NICU at birth, don't have mother with addiction, don’t take sedative during study and at least one hour before sampling, painful procedure wouldn’t carry out for them.
If neonates become ill, die or send to another hospital or have a surgery during study they will excluded from study.
Intervention groups
In intervention group neonates after doing intervention of reducing sounds will assess for level of stress with measuring saliva cortisol. In control group neonates before doing intervention receive routine care of ward and sampling of saliva cortisol will done for them.
Main outcome variables
Level of preterm neonate' stress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090405001788N20
Registration date:2018-11-19, 1397/08/28
Registration timing:retrospective
Last update:2018-11-19, 1397/08/28
Update count:0
Registration date
2018-11-19, 1397/08/28
Registrant information
Name
Leili Borimnejad
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6150 4212
Email address
borimnej@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-06, 1397/04/15
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sound reduction management on preterm neonate’ stress in NICU
Public title
Effect of sound reduction management on preterm neonate’ stress in NICU
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Neonate born with gestational age 26-36 week.
Neonate with birth weight 1000-2500 gr.
Neonate admit to NICU at birth.
At least one hour before sampling painful procedure wouldn’t carry out for infant.
Exclusion criteria:
Infant take sedative during study.
Addicted mother
Neonate with congenital abnormality on birth.
Age
From 2 days old to 3 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
3
For each sample 3 times in 3 consecutive days saliva cortisol sample will take.
Randomization (investigator's opinion)
N/A
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
Ethics committee of Iran University of medical Seinces
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-10-25, 1397/08/03
Ethics committee reference number
IR.IUMS.REC.1397.343
Health conditions studied
1
Description of health condition studied
Assess of level of preterm neonate' stress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Preterm neonate' stress
Timepoint
second to third days of birth
Method of measurement
Measuring level of saliva cortisol of samples
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For assessing the effect of sound reduction management on preterm neonate’ stress interventions for 3-4 weeks to reducing noise take place that it contain a combination of educational programs, reducing alarms of equipment and phone and doors sound, transfer neonates to incubator and teaching parents from time of admit about reducing noise. 2 weeks after intervention programs, sampling for saliva cortisol of preterm neonate in intervention group take place. Sampling for all infants 48-72 hours after birth and at 9-10 AM by sterile catheter, collecting in captive tube and will store in -20 temperature until analyzing. Samples will take for each neonate 3 times in 3 consecutive days. Samples for measuring cortisol will analysis by CLIA method. Sampling will do according to available samples and all neonates that admit to ward during study will assess. Due to the property of research community and difference of development level of neonates (gestational age 26-32, 32-36), A6 variable is base of planning study as Randomized block design.
Category
Behavior
2
Description
Control group: Samples in control group before doing interventions for reducing sound will take routine care and sampling will done for them like intervention group with same condition.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Therapeutic - educational Complex of emam ALI
Full name of responsible person
DR. Mahdavi Ahmad
Street address
Azymiee forked road
City
Karaj
Province
Alborz
Postal code
3136735173
Phone
+98 26 3252 7575
Fax
+98 26 3254 7128
Email
EMAMALI@abzums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seid Kazem Malakouti
Street address
Hemmat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 86710
Email
research@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
75
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
Iran University of Medical Sciences
Full name of responsible person
Dr. Leili Borimnejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Rashid Yassemi,Valiasr
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8888 2886
Email
borimnejad.l@iums.ac.ir
Web page address
htpp://fnm.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leili Borimnejad
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Rashid Yassemi,Valiasr
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8888 2886
Email
borimnejad.l@iums.ac.ir
Web page address
htpp://fnm.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Leili Borimnejad
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Rashid Yassemi,Valiasr
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 8888 2886
Email
borimnejad.l@iums.ac.ir
Web page address
htpp://fnm.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Data coding will done In order to keep confidentiality of the participants in the research.
When the data will become available and for how long
The end of sampling till six month after article publishing.
To whom data/document is available
Ethical , reviewer and editorial committees and other researchers.
Under which criteria data/document could be used
Systematic review and meta analysis or secondary analysis citation.
From where data/document is obtainable
Leili Borimnejad , borimnejad.l@iums.ac.ir
What processes are involved for a request to access data/document
After sending request by academic email, we will send them data files up to one week.