This study investigated the effect of the neonatal intensive care unit orientation program on the anxiety of premature infants’ mothers in Shahrekord. The study population included all the mothers of the infants who were hospitalized in the NICUs of Shahrekord. The inclusion criteria included the gestational age of 23 to 34 weeks at the time of hospitalization and hospitalization for at least one week. Mothers who their infants were hospitalized more than one month were excluded from the study. In this study, 64 mothers had participated and were divided into two groups of control and intervention. Random sampling was used by tossing. The intervention group received the designed educational program through three 20-minute in-person sessions. The participants of the control group just received the routine care. Study instruments were a questionnaire for gathering demographic variables, the parental stress scale questionnaire and the data collected before and after the intervention.
The main outcome of the study was stress.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011631972N1
Registration date:2017-07-08, 1396/04/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-08, 1396/04/17
Registrant information
Name
Mahlagha Dehghan Anari
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5201
Email address
m_dehghan@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Kerman University Of Medical Sciences
Expected recruitment start date
2016-02-02, 1394/11/13
Expected recruitment end date
2017-02-07, 1395/11/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of effect of an educational program on stress of premature infants’ parents hospitalized in neonatal intensive care units
Public title
The effect of education on stress reduction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: mothers should be at the age of 18 years or more; Being able to read and write; Not having a history of preterm delivery or giving birth abnormal baby; Not having a history of anxiety or depression disorders; Gestational age between 23 to 34 weeks at the time of hospitalization; hospitalization for at least one week; no history of stressful events during past 6 months and not having difficult pregnancy.
Exclusion criteria: Mothers who their infants were hospitalized over a month.
Age
From 1 year old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
To prevent data exchange between the
Control and intervention groups, time
Block method will be used. Random sampling
will be conducted first for intervention
Group and then control group by tossing
A coin; Meaning that after the sampling of
The intervention group will be completed, the
Sampling will be paused for three weeks so that
The mothers of the intervention group would
Be discharged. Then sampling for the control
The group will be conducted through the same
Method.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor For Research; Kerman University of Medical Sciences
Street address
Haft Baghe Alavi; Kerman
City
Kerman
Postal code
7617949546
Approval date
2016-02-20, 1394/12/01
Ethics committee reference number
IR.KMU.AC.1394013
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Stress
Timepoint
Before the intervention - Immediately after the intervention
Method of measurement
The scale of parental stress Miles and Monk
Secondary outcomes
empty
Intervention groups
1
Description
Control group: The participants of the control group just receive the routine care.
Category
Behavior
2
Description
Intervention group: mothers Will receive the designed educational program through three 20-minute in-person sessions. The educational content including introducing the neonatal ward, information about the personnel, the equipment that parents might see at the ward (monitor, respiratory equipment, phototherapy LED, etc.), care conditions (connected intravenous pipes, nasogastric feeding tube , blood transfusion, etc.), information about the infant’s appearance, the emotions that mothers may experience.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Borujen Valiasr Hospital
Full name of responsible person
Zeinab Taheri
Street address
Mellat blvd
City
Borujen
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor; for research of Kerman University of Medical Sciences
Full name of responsible person
Dr. Abbas Pardakhti
Street address
Razi School, Haft Baghe Alavi, Kerman
City
Kerman
Grant name
-
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor; for research of Kerman 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
Rafsanjan School of Nursing and Midwifery
Full name of responsible person
Aazam Heidarzadeh
Position
Master/instructor
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Jomhouri Eslami blvd
City
Rafsanjan
Postal code
7717896755
Phone
+98 34 3425 5900
Fax
+98 34258497
Email
heidarzadehaazam@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman Medical University
Full name of responsible person
Mansooreh Azizzadeh Forouzi
Position
Master of Science
Other areas of specialty/work
Street address
Razi School, Haft Baghe Alavi, Kerman
City
kerman
Postal code
7617949546
Phone
+98 34331325219
Fax
+98 34 3121 5218
Email
Forozy@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery Rafsanjan
Full name of responsible person
Aazam Heidarzadeh
Position
Master
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Jomhouri Eslami blvd
City
Rafsanjan
Postal code
7717896755
Phone
+98 34 3425 5900
Fax
+98 34258497
Email
heidarzadehaazam@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)