Protocol summary
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Study aim
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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
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Design
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Clinical trial with two groups of control and intervention, 75 samples
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Parents have preterm infants with a gestational age of 32-37 weeks that have no major malformations and are not dependent on the ventilator.
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2018-04-22, 1397/02/02
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-03-21, 1397/01/01
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Expected recruitment end date
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2018-06-20, 1397/03/30
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Actual recruitment start date
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2018-03-21, 1397/01/01
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Actual recruitment end date
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2018-08-22, 1397/05/31
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Trial completion date
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2018-09-11, 1397/06/20
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Scientific title
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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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Public title
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The impact of spousal support education to fathers on stress and self-efficacy score of mothers
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
75
Actual sample size reached:
75
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Factorial
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Other design features
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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.
Ethics committees
1
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Ethics committee
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Approval date
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2017-10-18, 1396/07/26
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Ethics committee reference number
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IR.SUMS.REC.1396.112
Health conditions studied
1
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Description of health condition studied
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stress
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ICD-10 code
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F43.0
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ICD-10 code description
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Acute stress reaction
Primary outcomes
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Description
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Stress mothers of premature infants
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Timepoint
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Measuring maternal stress on the second day of admission and the seventh day of admission
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Method of measurement
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By PSS questionnaire
Secondary outcomes
1
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Description
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Self-efficacy of mothers of premature infants
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Timepoint
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On the second day of admission, premature baby and the seventh day of admission
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Method of measurement
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By PMP-SE questionnaire
Intervention groups
1
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Description
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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.
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Category
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Other
2
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shiraz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available