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The effect of supportive educational interventions on stress and adaptation to the role of motherhood in mothers of preterm infants hospitalized in Neonatal Intensive Care Unit

Protocol summary

Study aim
Determining the effect of supportive educational interventions on stress and adaptation to the role of motherhood in mothers of preterm infants hospitalized in Neonatal Intensive Care Unit
Design
The statistical population includes all mothers of premature infants who are referred to the neonatal intensive care unit of Imam Reza Hospital in Kermanshah. After obtaining the necessary permissions, eligible mothers are enrolled in the study. First, control group samples and three weeks after the completion of control groups sampling, the intervention group samples are selected randomly. Intervention takes place in 2-3 sessions. In both groups, at first (before intervention), before discharge and one month after discharge, the level of stress and the degree of adaptation to the role of motherhood are assessed by using the Perceived Stress Scale 4 (PSS-4) and Maternal Role Adaptation Scale (MRAS: NICU).
Settings and conduct
Eligible mothers are selected and entered by referring to the neonatal intensive care unit of Imam Reza Hospital in Kermanshah.
Participants/Inclusion and exclusion criteria
Infant age between 26-26 weeks, fluent in Persian, age over 18, no history of mental disorders and psychoactive drugs use, lack of addiction, lack of known disease in the fetus, being Iranian, non-occurrence of an accident or loss of first class family members in the last three months, have a tendency to participate in the research and two to four days have passed since their baby was admitted.
Intervention groups
This study has an intervention and a control group.Intervention takes place in 2-3 sessions. In both groups, at first (before intervention), before discharge and one month after discharge, the level of stress and the degree of adaptation to the role of motherhood are assessed.
Main outcome variables
Perceived Stress and Maternal Role Adaptation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170305032900N2
Registration date: 2018-09-10, 1397/06/19
Registration timing: registered_while_recruiting

Last update: 2018-09-10, 1397/06/19
Update count: 0
Registration date
2018-09-10, 1397/06/19
Registrant information
Name
Sousan Heydarpour
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3823 2679
Email address
sheydarpour@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-10, 1397/06/19
Expected recruitment end date
2019-01-09, 1397/10/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of supportive educational interventions on stress and adaptation to the role of motherhood in mothers of preterm infants hospitalized in Neonatal Intensive Care Unit
Public title
The effect of supportive educational interventions on stress and adaptation to the role of motherhood in mothers of preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Neonate age between 26 to 36 weeks fluent in Persian language Mother's age over 18 years old Being Iranian Two to four days have passed since the baby was admitted
Exclusion criteria:
Not having a willingness to participate in the study Diagnosis of a known disease in the fetus history of mental disorders, psychotropic drug use and addiction
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study blinding will be performed for the processor. The processor will not be aware of the content of the codes.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of kermanshah University of Medical Sciences
Street address
Shahid Beheshti Boulevard; Central Building of Kermanshah University of Medical Sciences
City
kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2018-02-09, 1396/11/20
Ethics committee reference number
IR.Rec.1396.648

Health conditions studied

1

Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
All mothers of premature infants who are referred to Imam Reza Kermanshah Hospital, who are residents of Kermanshah, will be referred.
Timepoint
The intervention involves training the program in 2 to 3 sessions during the hospital stay
Method of measurement
Before discharge and one month after discharge, the level of stress was assessed using the perceived stress questionnaire and the degree of compliance with the maternal role was assessed using a questionnaire adapted to the role of maternal premature infants.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Training the program in 2 to 3 sessions with the help of video tutorials with a tablet and individually. Training includes how to care for a premature baby (previously provided by one of the researchers in Iran) and a training booklet.
Category
Behavior

2

Description
Control group: Ward routine care
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Fatemeh Tohidi Nezhad
Street address
Nursing Blvd, Sorkhe Ligeh, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6714415333
Phone
+98 83 3427 6301
Fax
+98 83 3427 6301
Email
www.fatimatohidi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sousan Heydarpour
Street address
Kermanshah, Shahid Beheshti Blvd, Central Building
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Email
www.fatimatohidi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Sousan Heydarpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Email
www.fatimatohidi@gmail.co

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
sousan Heydarpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Email
www.fatimatohidi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Sousan Heydarpour
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Nurse Blvd, Sorkhelije, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3835 8943
Email
www.fatimatohidi@gmail.com

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
Yes - There is a plan to make this available
Title and more details about the data/document
All participants data can be shared after being unidentified
When the data will become available and for how long
Start the access period after publishing the results
To whom data/document is available
Public
Under which criteria data/document could be used
For use in studies allowed
From where data/document is obtainable
sousan Heydarpour Email: sheydarpour@kums.ac.ir mobile: 00989183366206
What processes are involved for a request to access data/document
The application will be sent to the project implementer by email and within 24 hours will receive the necessary items
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