Investigating the impact of supportive program on the stress and anxiety of fathers in the first exposure to preterm infant
Design
Randomized Clinical trial, sample size=80
Settings and conduct
This study is will be conducted in the public hospital of Shahid Motahari, in Urmia. the researcher invites eligible study units to collaborate. The study units, will be divided into intervention and control groups based on randomization. After filling out State-Trait Anxiety (STAI) Inventory, the first encounter of the father with the infant was established based on the mother's placement, in interventional or control group based on randomization. After intervention, Parental Stressor Scale: Neonatal Intensive Care Unit (PSS-NICU) and STAI Inventories will be filled.
Participants/Inclusion and exclusion criteria
Fathers of preterm infants
Intervention groups
In the intervention group, two albums with the photos of a preterm babies will be shown to the father, and will be trained how to store and transport the breast milk, Then the father will be taken to the infant's bedside and empowered to have a comfortable interaction with the infant, then characteristics of premature infants and equipment around the baby and unit routine will be explained simply.At the end, DVD and pictorial training booklets on preterm infant’s characteristics, will be given to the father, and the researcher’s telephone number will be given to father to ask any possible question. In the control group, the father goes to the baby's bed and the baby's nurse answers any questions.
Main outcome variables
Stress, anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200120046200N1
Registration date:2020-05-11, 1399/02/22
Registration timing:prospective
Last update:2020-05-11, 1399/02/22
Update count:0
Registration date
2020-05-11, 1399/02/22
Registrant information
Name
Seyedeh saeedeh Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4365 1807
Email address
mousavi.ss@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-20, 1399/03/31
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of supportive program on the stress and anxiety of fathers in the first exposure to premature infant
Public title
Effect of supportive program on the stress and anxiety of fathers
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Fathers:
Over 18 years of age
Literacy
Lack of employment in health centers
Ability to communicate verbally
No stressful events in the past 6 months (such as divorce, separation from spouse, job loss)
Lack of any mental illness or history of mental illness, according to the research unit
No history of infertility
Visitors to the hospital eventually 12 hours after preterm delivery
Neonates:
Gestational age less than 37 weeks
Fifth minute apgar above 5
single pregnancy
Exclusion criteria:
Any congenital malformations
Any serious disabling conditions: such as grade 3 or 4 intraventricular hemorrhage
Age
From 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization using Quadratic Random Block
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 Iran University of Medical Sciences
Street address
ّّFifth floor, Headquarters., Iran University of Medical Sciences., Hemmat Highway between Chamran and Sheikh Fazlullah
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-03-15, 1398/12/25
Ethics committee reference number
IR.IUMS.REC.1398.1361
Health conditions studied
1
Description of health condition studied
The effect of supportive program on fathers' stress and anxiety in first exposure to preterm infant
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Father's anxiety
Timepoint
Baseline, day three
Method of measurement
State Trait Anxiety Inventory(STAI)
2
Description
Stress
Timepoint
Day three
Method of measurement
Parental Stressor Scale: Neonatal Intensive Care Unit (PSS: NICU)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group two albums are shown to the father. One album includes photos of a premature baby from birth to about two years old, and another album includes photos of former premature babies and current and well-to-do children, all born of different weights and ages. By showing these photos, we aim to prepare the father to see our baby with the features of a premature infant (intelligence support), on the one hand, and to provide emotional support for the future on the other, with conversations that show Photographs will be attempted, with the father's beliefs emphasized on trust, resort, patience, and submission to divine fate (spiritual support), and then the mother's milk storage and transportation will be taught and taught. The device tries, while supporting information, with the hope that our premature infant will eat our milk. There will also be emotional support for the father, at which point the father will be advised to enter the ward and, as he enters, the staff will be introduced to him, followed by the father to the infant's bed, and to engage in sedentary interactions with him. The baby is encouraged and empowered through continuous gentle touch, gentle whispering in the ear, and eye contact. Alongside the baby, the characteristics of the premature baby and the equipment around the premature baby will be explained in a simple, understandable language and will answer any further questions the father has about the baby, the environment and the routine equipment. At the end of the illustrated booklet and DVD, information will be provided to the father on the conditions and characteristics of preterm infants, the needs and alternatives of indirect and indirect nutrition, the general conditions and common problems of preterm infants for the next 3 days and during hospitalization. Their infants can use it and revive it in their minds if they forget to read and observe some topics. The father will also be given a telephone number to answer any questions he may have during these 3 days. On the third day, the father's anxiety questionnaire for the second time and the stress questionnaire for the first time.
Category
Other
2
Description
Control group: In the control group, the father goes to the infant's bed and the infant's nurse answers any questions he may have. On the third day, the control group fathers will be given a second anxiety and stress questionnaire for the second time after completing the anxiety questionnaire and educational DVD and a telephone number will be provided to the father with any possible questions. Respond after reading the book and watching the DVD.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Hospital of Urmia
Full name of responsible person
Paria Jafari
Street address
Not reached the state of Shahid Motahhari Hospital, Kashani Street,Urmia
City
Urmia
Province
West Azarbaijan
Postal code
57147
Phone
+98 44 3223 7077
Email
motahari@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
kazem Malakouti
Street address
Area Two, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 9024 6650
Email
malakoutik@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Seyedeh saeedeh Mousavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1807
Email
mousavi.ss@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh saeedeh Mousavi
Position
Associate professo
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1807
Fax
Email
mousavi.ss@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyedeh saeedeh Mousavi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Health
Street address
School of Nursing and Midwifery., Rashid Yasimi Street., above Vanak Square., Valiasr Street
City
Tehran
Province
Tehran
Postal code
1996713883
Phone
+98 21 4365 1807
Email
mousavi.ss@iums.ac.ir
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
Yes - There is 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
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document