English Title: Effects of the father empowerment program on the father's stress score and perceived social support of the mothers with premature neonates in neonatal intensive care unit
Investigating the impact of the father empowerment program on the father's anxiety and care burden of mothers
Design
A non-randomized, controlled, parallel-group, single-blind, phase 3 clinical trial on 60 patients.
Settings and conduct
The environment of the study is Mehr Madar Torbat Jam Hospital. The population of this study is fathers and mothers with premature babies hospitalized in the NICU who meet the inclusion criteria. Sampling will be done by convenience methods. The study tools include the demographic information form, the parental stress scale:NICU and the multidimensional perceived social support scale . After the approval of the ethics committee, the father empowerment package will be designed first. Sampling of the control group is done at the same time. After completing the control group, sampling of the intervention group will begin. Data collection will be done on the first and seventh day. The data will be compared between the control and intervention groups in the two stages before and after.
Participants/Inclusion and exclusion criteria
Admission: fathers and mothers who have a premature baby hospitalized in the NICU.
Intervention groups
Intervention group: fathers who will receive empowerment program. In this group according to coordination with the ward, in the afternoons father stays at the baby's bedside for 2 to 4h. During this interval, the mother can choose to rest in the mother's room, go home and rest, or stay with her husband. After this time, father delivers the baby to the mother. The rest of the care of the baby will be left to the mother until the evening of the next day under the supervision of the nurse. The intervention will continue for 7 days.
the control group:The control group will be administered according to the ward routine.
Main outcome variables
Fathers' anxiety score and mothers' perceived social support score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221129056663N1
Registration date:2023-02-08, 1401/11/19
Registration timing:registered_while_recruiting
Last update:2023-02-08, 1401/11/19
Update count:0
Registration date
2023-02-08, 1401/11/19
Registrant information
Name
Hossein Nourmohammadih
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3514 7351
Email address
nourmohammadih982@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-16, 1401/10/26
Expected recruitment end date
2023-05-31, 1402/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
English Title: Effects of the father empowerment program on the father's stress score and perceived social support of the mothers with premature neonates in neonatal intensive care unit
Public title
non randomized Clinical trial
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Fathers and mothers with premature babies admitted to the Neonatal Intensive Care Unit.
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
2
Fathers and mothers of premature babies
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The only person who will be blind in this study is the statistical analyst of the study who will be unaware of the allocation of people to control and intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Deputy of technology and research of Mashhad University of Medical Sciences Qurashi building Next to Hoveize cinema University street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2022-10-31, 1401/08/09
Ethics committee reference number
IR.mums.nurse.rec.1401.072
Health conditions studied
1
Description of health condition studied
prematurity
ICD-10 code
P07.30
ICD-10 code description
Preterm newborn, unspecified weeks of gestation
Primary outcomes
1
Description
Fathers' stress score
Timepoint
It is done in two stages, once before the intervention and then after the intervention on the seventh day or the day of discharge from the hospital, whichever is earlier.
Method of measurement
Fathers' stress level questionnaire is completed by fathers
2
Description
Mother's perceived social support
Timepoint
It is done in two stages, once before the intervention and then after the intervention on the seventh day or the day of discharge from the hospital, whichever is earlier.
Method of measurement
Questionnaire of perceived social support will be completed by mothers.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: the group of fathers who receive the empowerment program. First, the father empowerment package is designed. Then, with the coordination of the department, the fathers come to the baby's bedside for 2 to 4 hours in the afternoon and take care of the baby under the supervision of the nurse and based on the empowerment package. 7 days after the intervention, the results are measured in two groups.
Category
Other
2
Description
Control group: fathers who did not receive the empowerment program. In this group, care is provided according to the department's routine. This means that all care is provided by the mother under the supervision of a nurse. Fathers can only visit the mother or the baby at the bedside and do not take care of the baby
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehrmother Women's Specialized Hospital
Full name of responsible person
Dr. Yekta Javadani
Street address
Imam Khomeini street
City
Torbat Jam
Province
Razavi Khorasan
Postal code
9571977484
Phone
+98 51 5254 2503
Email
info@trjums.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Majid Ghayur
Street address
University Street, next to Hoizeh Cinema, Qurashi Building, Research and Technology Vice_Chancellor
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mrs.Aramesh Rezaeian
Position
Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Mashhad University of Medical Sciences,University Street
City
mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 912 175 9558
Email
RezaeianA@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Torbate-Jam University of Medical Sciences
Full name of responsible person
Hossein Nurmohammadi
Position
Management of nurses
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 8,right side, 2nd intersection,3 Pasdaran St.
City
Torbat jam
Province
Razavi Khorasan
Postal code
9571933819
Phone
+98 51 5254 2505
Email
Nourmohammadih982@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Jam University of Medical Sciences
Full name of responsible person
Hossein Nurmohammadi
Position
Management of nurses
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 8,right side, 2nd intersection,3 Pasdaran St.
City
Torbat Jam
Province
Razavi Khorasan
Postal code
9571933819
Phone
+98 51 5254 2505
Email
Nourmohammadih982@mums.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
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