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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.

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History
# Registration date Revision Id
2 2018-08-25, 1397/06/03 63082
1 2018-04-22, 1397/02/02 43122
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  • Protocol summary

    Clinical trial with two groups of control and intervention, 60 samples
    Clinical trial with two groups of control and intervention, 75 samples
    کارآزمایی بالینی دارای دو گروه کنترل و مداخله، حجم ۶۰ نمونه
    کارآزمایی بالینی دارای دو گروه کنترل و مداخله، حجم ۷۵ نمونه

  • General information

    Female
    Both
    60
    75
    empty
    75
    empty
    2018-03-21, 1397/01/01
    empty
    2018-08-22, 1397/05/31
    empty
    2018-09-11, 1397/06/20
    empty
    In order to prevent transfer of the training content to the control proup, the two groups had to be sampled separately. On the other hand, in order for nurses not to be affected by the intervention and their behavior not to be changed, the control group in each hospital has been sampled, primarily. Thus, the allocation of parents to each group took place after complete sampling of the control group at first place, in each hospital. That is, after the coin toss, sampling was made in Hafez and Nemazee Hospitals on odd and even days, respectively.
    empty
    به منظور عدم انتقال آموزش ارائه شده به پدران از گروه مداخله به گروه کنترل لازم بود که ۲ گروه به طور مجزا نمونه گیری شوند و از طرفی برای عدم تأثیر مداخله بر پرستاران و تغییر رفتار ایشان بایستی ابتدا گروه کنترل در هر بیمارستان نمونه گیری می‌شد. لذا نحوه تخصیص والدین به دو گروه به این شكل بود که در هر بیمارستان ابتدا گروه کنترل به طور کامل نمونه‌گیری شد. به این صورت که پس از پرتاب سکه در روزهای فرد نمونه‌گیری در بیمارستان حافظ و در روزهای زوج در بیمارستان نمازی انجام شد.

  • Health conditions studied

    #1
    f43.23
    F43.0
    Adjustment disorder with mixed anxiety and depressed mood
    Acute stress reaction
    Assessing the stress of a mother with preterm infants
    stress
    سنجش استرس مادر دارای نوزاد نارس
    استرس

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hamed Gasemloo
    Full name of responsible person - Persian: حامد قاسملو
    Position - English: Master student
    Position - Persian: دانشجوی کارشناسی ارشد
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shiraz, Square Eram ,Dormitory of Shahid Dastgheib
    Street address - Persian: شیراز میدان ارم خوابگاه شهید دستغیب(ره)
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7194684695
    Phone: +98 44 3366 4762
    Mobile: +98 914 296 8808
    Fax:
    Email: hamedgasemloo@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hamed Gasemloo
    Full name of responsible person - Persian: حامد قاسملو
    Position - English: Master student
    Position - Persian: دانشجوی کارشناسی ارشد
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Dormitory of Shahid Dastgheib, Eram Square,Shiraz
    Street address - Persian: شیراز، میدان ارم، خوابگاه شهید دستغیب(ره)
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 7194684695
    Phone: +98 44 3366 4762
    Mobile: +98 914 296 8808
    Fax:
    Email: hamedgasemloo@gmail.com
    Web page address:

  • Person responsible for scientific inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zahra Hadian Shirazi
    Full name of responsible person - Persian: زهرا هادیان شیرازی
    Position - English: associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shiraz, Namazi Square, Faculty of Nursing Hazrat Fatemeh
    Street address - Persian: شیراز، میدان نمازی، دانشکده پرستاری حضرت فاطمه(س)
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 13119–71936
    Phone: +98 71 3647 4254
    Mobile: +98 917 119 3910
    Fax:
    Email: zhadian@sums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Zahra Hadian Shirazi
    Full name of responsible person - Persian: زهرا هادیان شیرازی
    Position - English: associate professor
    Position - Persian: دانشیار
    Latest degree: phd
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Faculty of Nursing Hazrat Fatemeh, Namazi Square, Shiraz
    Street address - Persian: شیراز، میدان نمازی، دانشکده پرستاری حضرت فاطمه(س)
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 13119–71936
    Phone: +98 71 3647 4254
    Mobile: +98 917 119 3910
    Fax:
    Email: zhadian@sums.ac.ir
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hamed Gasemloo
    Full name of responsible person - Persian: حامد قاسملو
    Position - English: Master student
    Position - Persian: دانشجوی کارشناسی ارشد
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Shiraz, Square Eram ,Dormitory of Shahid Dastgheib
    Street address - Persian: شیراز میدان ارم خوابگاه شهید دستغیب(ره)
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 71946-84695
    Phone: +98 44 3366 4762
    Mobile: +98 914 296 8808
    Fax:
    Email: hamedgasemloo@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Hamed Gasemloo
    Full name of responsible person - Persian: حامد قاسملو
    Position - English: Master Student
    Position - Persian: دانشجوی کارشناسی ارشد
    Latest degree: bachelor
    Area of specialty/work: 27
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Dormitory of Shahid Dastgheib, Square Eram, Shiraz
    Street address - Persian: شیراز، میدان ارم، خوابگاه شهید دستغیب(ره)
    City - English: Shiraz
    City - Persian: شیراز
    Province: Fars
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 71946-84695
    Phone: +98 44 3366 4762
    Mobile: +98 914 296 8808
    Fax:
    Email: Hamedgasemloo@gmail.com
    Web page address:

  • Sharing plan

    undecided
    no
    undecided
    no
    undecided
    no
    undecided
    no
    undecided
    no
    undecided
    no
    undecided
    no

Protocol summary

Study aim
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, 75 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: 2018-10-14, 1397/07/22
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
2018-03-21, 1397/01/01
Actual recruitment end date
2018-08-22, 1397/05/31
Trial completion date
2018-09-11, 1397/06/20
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
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 75
Actual sample size reached: 75
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features
In order to prevent transfer of the training content to the control proup, the two groups had to be sampled separately. On the other hand, in order for nurses not to be affected by the intervention and their behavior not to be changed, the control group in each hospital has been sampled, primarily. Thus, the allocation of parents to each group took place after complete sampling of the control group at first place, in each hospital. That is, after the coin toss, sampling was made in Hafez and Nemazee Hospitals on odd and even days, respectively.

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
stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction

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
Dormitory of Shahid Dastgheib, Eram Square,Shiraz
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
Faculty of Nursing Hazrat Fatemeh, Namazi Square, Shiraz
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
Dormitory of Shahid Dastgheib, Square Eram, Shiraz
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)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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