The effect of mother's voice on preterm neonates' physiological parameters and mothers' parental perception in the Neonatal Intensive Care Unit of Mehr Hospital, Malayer,2016.
The main objective of the project:The effect of mother's voice on preterm neonates' physiological parameters and mothers' parental perception in the Neonatal Intensive Care Unit
Secondary objectives:
Compare neonate's heart rate and oxygen saturation befor, during and after the intervention.
Compar mothers' parental perception before ,during and after intervention
Inclusion criteria: Age at birth based on the result lmp history, ultrasound between 30-37 weeks;Is incubated;Not under mechanical ventilation;No intrauterine growth retardation;Intracerebral hemorrhage is not more than grade 2; Infant beds lowering therapy not conscious ;Two days of infant hospitalization in the past;
Baby's chromosomes or abnormalities, congenital anomalies havenot;The doctor is certified by reflex moro infant hearing health advice;doesnt distress breathing;Not multiple.
Mother: Drug addiction is not; history of smoking cigarettes during pregnancy is not;known any psychological illness resulting in hospitalization is not.
study population: mothers and preterm infant hospitalized in the neonatal intensive care unit
sampel:36 neonates,36 mothers
intervention:speech mother with preterm neonates
time:10minutes
primary outcome:improve oxyjen blood,respiratory rate,stability heart rate in neonate,incease mothers' parental perception .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016072729104N1
Registration date:2016-09-23, 1395/07/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-09-23, 1395/07/02
Registrant information
Name
Zahra Afshari
Name of organization / entity
Hamedan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81383805358
Email address
zah.afshari@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan Univresity Of Medical Sciences
Expected recruitment start date
2016-08-27, 1395/06/06
Expected recruitment end date
2016-10-06, 1395/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mother's voice on preterm neonates' physiological parameters and mothers' parental perception in the Neonatal Intensive Care Unit of Mehr Hospital, Malayer,2016.
Public title
The effect of mother's voice on preterm neonates'vital signs and mothers' parental perception in the Neonatal Intensive Care Unit
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Age at birth based on the result lmp history, ultrasound between 30-37 weeks; Is incubated;Not under mechanical ventilation;No intrauterine growth retardation; Intra cerebral hemorrhage is not more than grade ; Infant not treated with drugs to reduce the level of conscious ;Two days past of infant's hospitalization
Baby's chromosomes or abnormalities, congenital anomalies havenot;The doctor is certified infant's hearing health by reflex moro;neonate dosent respiratory distress ;Not multiple.
Mother: Drug addiction is not ;history of smoking cigarettes during pregnancy is not;known any psychological illness resulting in hospitalization is not.
exclusion criteria
early discharge infant;any change in the status of infant was taken to'll need to get respiratory support; symptoms of hypoglycemia or hypocalcemia;
the absence of a parent to continue project.
Age
From 2 days old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan Of university sciences
Street address
Hamedan, Opposit Mardom Park, Shahid Fahmide Avenue
City
Hamedan
Postal code
6517838698
Approval date
2016-05-15, 1395/02/26
Ethics committee reference number
IR.UMSHA.REC.1395.91
Health conditions studied
1
Description of health condition studied
PRETERM NEONATE
ICD-10 code
060-075
ICD-10 code description
Complications of labour and delivery
Primary outcomes
1
Description
HEART RATE
Timepoint
5 MINUTE BEFOR INTERVENTION 10 MINUTE DURING INTERVENTION 5MINUTE AFTER INTERVENTION
Method of measurement
HR MEASURE BY MONITORING DEVICI IN 1 MINUTE
2
Description
Respiratory rate
Timepoint
5 MINUTE BEFOR INTERVENTION 10 MINUTE DURING INTERVENTION 5MINUTE AFTER INTERVENTION
Method of measurement
COUNTING RESPIRATORY RATE IN1 MINUTE BY RESEARCHER
3
Description
SATURATION O2 PERCENT
Timepoint
5 MINUTE BEFOR INTERVENTION 10 MINUTE DURING INTERVENTION 5MINUTE AFTER INTERVENTION
Method of measurement
HR MEASURE BY MONITORING DEVICI IN 1 MINUTE
4
Description
mothers' parental perception
Timepoint
first day befor intervention and the end thirth day
Method of measurement
mothers' parental perception questionnaire
Secondary outcomes
1
Description
sever reactoin to acoustic stimulationby syptom cry ,screaming
Timepoint
in time intrvention: 10 minute
Method of measurement
by observing neonate
Intervention groups
1
Description
speach mother with preterm neonate10 minute in 3 days consecutive in intervention group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr Hospital
Full name of responsible person
Zahra Afshari
Street address
Malayer Nabovat Avenu
City
Malayer
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center Shool Of NursingUniversity Hamedan
Full name of responsible person
Fateme Cheragi
Street address
Hamedan,Across Mardom Park. Shahid Fahmide Avenu
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center Shool Of NursingUniversity Hamedan
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
Hamedan University Of Medical ScienceS
Full name of responsible person
Zahra Ashari
Position
Student BA. Nurse
Other areas of specialty/work
Street address
Malaye, Shariat Dead lock, Arak Street.
City
Malayer
Postal code
Phone
+98 81 3224 4239
Fax
Email
afshari.z1981@gmail .com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan nursing
Full name of responsible person
Fatheme Cheragi
Position
PHD Nursing
Other areas of specialty/work
Street address
Hamedan,Ostadane Street
City
Hamedan
Postal code
Phone
+98 81 3224 4239
Fax
Email
f_cheragi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University Of Medical Sciences
Full name of responsible person
Zahra Afshari
Position
BA. Nurse
Other areas of specialty/work
Street address
Malayer
City
Malayer ,Shariat Deadlock., Arak Street
Postal code
6571995154
Phone
+98 81 3224 4239
Fax
+98 33 51041
Email
afshari.z1981@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)