The impact of spousal support education to fathers on stress and self-efficacy score of mothers in care of premature neonates hospitalized in neonatal intensive care unit of Shiraz University of Medical Sciences 2017.
Determine the effectiveness of spousal support to fathers, stress and self-efficacy scores of mothers in the care of premature infants hospitalized in neonatal intensive care unit
Design
Clinical trial with two groups of control and intervention, 60 samples
Settings and conduct
At each hospital, the control group will be fully sampled. It will be done at sampling days at Hafez Hospital and on coupled days at Namazi Hospital. Then the intervention group will be sampled as mentioned.
Participants/Inclusion and exclusion criteria
Parents have preterm infants with a gestational age of 32-37 weeks that have no major malformations and are not dependent on the ventilator.
Intervention groups
In the control group, routine care is provided, but the fathers of the intervention group will receive an educational support program that includes two 60-minute training sessions using PowerPoint, as well as a training package containing CDs and booklets, and at the end of the first session Fathers also receive the necessary clinical training in the unit. One day after the end of the educational intervention, the parents will have the opportunity to meet and take care of the newborn for 3 days in an hour other than an appointment.
Main outcome variables
The primary outcome is the study of maternal stress and the secondary outcome of maternal self-efficacy, which will be measured by the PSS Stress Questionnaire and the PMP-SE self-efficacy questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171130037691N1
Registration date:2018-04-22, 1397/02/02
Registration timing:registered_while_recruiting
Last update:2018-04-22, 1397/02/02
Update count:1
Registration date
2018-04-22, 1397/02/02
Registrant information
Name
Hamed Gasemloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3366 4762
Email address
stud2900054001@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of spousal support education to fathers on stress and self-efficacy score of mothers in care of premature neonates hospitalized in neonatal intensive care unit of Shiraz University of Medical Sciences 2017.
Public title
The impact of spousal support education to fathers on stress and self-efficacy score of mothers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Parents with preterm infants born at gestational age of 32-37 weeks of gestation
Neonates not being Under the mechanical ventilation
The absence of congenital anomalies in the neonate
After two days of admission for neonates
No history of premature infants hospitalized earlier in pregnancy
Parental exposure to other stressful events in the last 6 months
Wanting to have a pregnancy
No history of taking medications affecting maternal mental health
Parents wanting to participate in the study
Having at least elementary education
Not being twin or upper
Dominance in Persian
Unemployment to medical group professions
Exclusion criteria:
The baby with major malformations
Baby connected to the ventilator
Use of anxiety drugs and drugs that affect the mental health of the mother before starting the study
The experience of admission of premature infants in the neonatal intensive care unit
Parents face a stressor in the last six months
Twin being
Parental inconvenience to participate in the study
mother is illiterate
Neonate with gestational age less than 32 weeks of gestation and over 37 weeks of gestation
Mother educated from medical science
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz-Zand Avenue, opposite the Palestine Street, the central building of Shiraz University of Medical Sciences postal code
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2017-10-18, 1396/07/26
Ethics committee reference number
IR.SUMS.REC.1396.112
Health conditions studied
1
Description of health condition studied
Assessing the stress of a mother with preterm infants
ICD-10 code
f43.23
ICD-10 code description
Adjustment disorder with mixed anxiety and depressed mood
Primary outcomes
1
Description
Stress mothers of premature infants
Timepoint
Measuring maternal stress on the second day of admission and the seventh day of admission
Method of measurement
By PSS questionnaire
Secondary outcomes
1
Description
Self-efficacy of mothers of premature infants
Timepoint
On the second day of admission, premature baby and the seventh day of admission
Method of measurement
By PMP-SE questionnaire
Intervention groups
1
Description
Control group: In the control group, the fathers will meet on a routine basis within the specified hours and will not be associated with the research team during the admission.
Category
Other
2
Description
Intervention group:In intervention group, educational interventions will be conducted. This intervention will take place 2 days after the newborn is admitted to the intensive care unit. It includes two 60-minute face-to-face training sessions with fathers of premature infants about the environment, equipment, health care staff and therapeutic care such as vein therapy , Oxygen therapy and ..., and information on premature infants (physical behaviors and symptoms), the role of the father in the protection and care of the baby and the mother, physical and mental changes created in the mother after childbirth, by the researcher using PowerPont will be provided. And questions and answers will be made between the researcher and the fathers about the subjects presented. At the end of the first session, a color booklet with an educational CD containing the educational content provided by the researcher and approved by the professors will be given to the fathers and the method of their use will be taught to the fathers. At the end of the first session, the fathers will visit the section And getting acquainted with the equipment and personnel of the department will be given to the department and the necessary training will be given in the section as well. One day after the end of the educational intervention to provide support for the parent and to exchange ideas and information between parents, the parents have the opportunity to meet for 3 days per hour, other than an appointment (in coordination with the manager and the department manager). Find and take care of the baby.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Hamed Ghasemloo
Street address
Namazai Square, Namazi hospital
City
Shiraz
Province
Fars
Postal code
۷۱۹۳۷-۱۱۳۵۱
Phone
+98 71 3647 4332
Email
hamedgasemloo@gmail.com
2
Recruitment center
Name of recruitment center
Hafez hospital
Full name of responsible person
hamed ghasemloo
Street address
Chamran Blvd., Hafez Hospital
City
Shiraz
Province
Fars
Postal code
34786 - 71946
Phone
+98 71 3627 1531
Email
hamedgasemloo@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Basir Hashemi
Street address
Zand Avenue, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Phone
+98 71 3235 2559
Email
hamedgasemloo@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Hamed Gasemloo
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shiraz, Square Eram ,Dormitory of Shahid Dastgheib
City
Shiraz
Province
Fars
Postal code
7194684695
Phone
+98 44 3366 4762
Fax
Email
hamedgasemloo@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Hadian Shirazi
Position
associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shiraz, Namazi Square, Faculty of Nursing Hazrat Fatemeh
City
Shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Email
zhadian@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamed Gasemloo
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shiraz, Square Eram ,Dormitory of Shahid Dastgheib
City
Shiraz
Province
Fars
Postal code
71946-84695
Phone
+98 44 3366 4762
Fax
Email
hamedgasemloo@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