Determining of the effect of home visit educational program on prematur infant's mothers anxiety
Design
Mothers in this quasi-experimental study will be divided into two intervention and control groups with parallel groups using available sampling method without blindness
Settings and conduct
For this study 70 mothers with preterm infants, Who have the inclusion criteria are selected and divided into two groups of 35.The researcher referred to the homes of these mothers and Anxiety Inventory (Spielberger) is completed by the mother before the beginning of the educational program and the next month
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The preterm infants with 28-37 weeks of gestation, The preterm infants without brain disorders,Congenital heart diseases, Metabolic or endocrine diseases,Known genetic and chromosomal disorders and intraventricular hemorrhage, No experience of the hospitalized infant in NICU or the death of infant,Lack of stressful events at the time of intervention in the family including no separation,No death of first-degree relatives in the past six months,The mother is not a member of the healthcare team.
Exit criteria:
The preterm infants with congenital anomalies and nervous system,The parents have other children with serious illness, Experience of the hospitalized infant in NICU or the death of infant, Presence of stressful events at the time of intervention in the family such divorcement or as losing the job or and death of first-degree relatives in the past six months,The parents cannot read and write in Persian, Use of mother-given anxiety medication, Mother addiction to all kinds of drugs
Intervention groups
Intervention group: Group with educational program: The researcher will arrange a home visit training program with educational contents.
Control group: Group without educational program
Main outcome variables
Anxiety
General information
Reason for update
Acronym
NICU
IRCT registration information
IRCT registration number:IRCT20180729040621N1
Registration date:2018-12-02, 1397/09/11
Registration timing:registered_while_recruiting
Last update:2018-12-02, 1397/09/11
Update count:0
Registration date
2018-12-02, 1397/09/11
Registrant information
Name
Maryam Valiollahibisheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3230 2422
Email address
m.valiollahi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of home visit educational program on prematur infant's mothers anxiety
Public title
The effect of home visit educational program on prematur infant's mothers anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The preterm infants with 28-37 weeks of gestation
The preterm infants without brain disorders, Congenital heart diseases, Metabolic or endocrine diseases,Known genetic and chromosomal disorders and intraventricular hemorrhage
Not having a previous experience of the hospitalized infant in NICU or the death
Lack of stressful events at the time of intervention in the family including no separation and no death of first-degree relatives in the past six months
The mother is not a member of the healthcare team.
Exclusion criteria:
The preterm infants with congenital anomalies and nervous system
The parents have other children with serious illness
Experience of the hospitalized infant in NICU or the death of infant
Presence of stressful events at the time of intervention in the family such divorcement or as losing the job,or death of first-degree relatives in the past six months
The parents cannot read and write in Persian
The mother uses the anxiolytics and has the history of drug addiction.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
This study was a quasi-experimental study with two groups of test and control that mothers were divided into two groups of test and control by random block allocation sampling method.In this way, mothers are randomly assigned randomized groups using four random blocks and four in the test and control groups.
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 Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganj Afrooz Avenue
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2018-03-03, 1396/12/12
Ethics committee reference number
MUBABOL. HRI. REC.1396.227
Health conditions studied
1
Description of health condition studied
Mothers anxiety
ICD-10 code
F06.0
ICD-10 code description
Psychotic disorder with hallucinations due to known physiological condition
Primary outcomes
1
Description
Anxiety
Timepoint
At the beginning of the study (before the intervention),after 2 sessions and 4 weeks after the last training session in the intervention group
Method of measurement
Spielberger STAI
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Educational program
Category
Behavior
2
Description
Control group: Group without educational program
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Rouhani Hospital
Full name of responsible person
Mayam Valiollahibisheh
Street address
Rouhani Hospital,Ganj Afrooz Avenue, Keshavarz Street
City
Babol
Province
Mazandaran
Postal code
4715766684
Phone
+98 11 3230 2422
Fax
Email
M.Valiollhi@mubabol.ac.ir
2
Recruitment center
Name of recruitment center
Children's Hospital of Shafizadeh Amirkola
Full name of responsible person
Mayam Valiollahibisheh
Street address
Shafizadeh Hospital, Imam Ali Street, Amirkola
City
Amirkola
Province
Mazandaran
Postal code
4715766684
Phone
+98 11 3230 2422
Email
M.Valiollhi@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Research Assistant - Dr. Reza Ghadimi
Street address
Babol University of Medical Sciences, Street Ganj Afrouz, Keshavarz St.,
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3219 9592
Email
Maryamvaliollahi76@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Parvin Aziznejadroshan
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Babol University of Medical Sciences, Ganj Afrooz St., Keshavarz St.
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3219 9592
Email
aziznejadroshan@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Parvin Aziznejadroshan
Position
Asistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Babol University of Medical Sciences,Ghanj Afroz, St Keshavarz St
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11321995926
Email
aziznejadroshan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Maryam Valiollahibisheh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti Complex، VAdine 1, Golestan Street 23, Valiasr Blvd.
City
Babol
Province
Mazandaran
Postal code
4715766684
Phone
+98 11 3230 2422
Email
Maryamvaliollahi76@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available