Determining the effect of group discussion between mothers and caregivers team about premature infants on stress and coping in neonatal intensive care unit. Designing the study: this is a quasi-experimental study with two intervention and control groups. Environment: neonatal intensive care units of Arash and Valiasr hospitals, affiliated to Tehran University of Medical Sciences. Population: mothers with gestational age less than 35 weeks with the risk of hospitalization for more than two weeks in the neonatal intensive care unit. Sampling: available sampling between mothers with less than 35 weeks of gestation based on inclusion criteria. Inclusion criteria: mothers under 35 weeks with risk of hospitalization for more than two weeks, no history of mental illness. Exclusion criteria: mothers of infants who have had surgery or died, or did not participate in two of four sessions of group discussion. Sample size: two intervention and control groups, each with 40 individuals. Intervention Studied: group discussion sessions between mothers and premature infants' care team in two intervention and control groups. The intervention was performed in intervention group as meetings between mothers and caregivers teams, in cases of premature infants in groups with 6-10 individuals, twice a week, each session 60 minutes, for two weeks. The control group program will be routine. In each group, parenting stress and The Brief Cope questionnaires were filled at first three days of admission and two weeks later; results of the questionnaires were compared in the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120631262N1
Registration date:2017-03-10, 1395/12/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-03-10, 1395/12/20
Registrant information
Name
Zobeydeh Saada
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66717695
Email address
saada_z@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group discussion between mothers and caregivers team about premature neonate on their stress and coping in Neonatal Intensive Care Unit
Public title
The effect of group discussion between mothers and caregivers team about premature neonate on their stress and coping in Neonatal Intensive Care Unit
Purpose
Supportive
Inclusion/Exclusion criteria
: inclusion criteria consisted of mothers with infants hospitalized in neonatal intensive care unit at gestational age less than 35 weeks. Mothers' willingness to participate in the study, no history of mental illness and use of psychotropic drugs, the ability to understand and read in Persian, no previous premature infants, and risk of hospitalization for more than two weeks. Exclusion criteria included surgical complications for infants, or not participating in two of four meeting or the baby death.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Tehran University of Medical Sciences
Street address
Tehran
City
Tehran
Postal code
1419733171
Approval date
2017-02-04, 1395/11/16
Ethics committee reference number
IR.TUMS.FNM.REC.1395.1639
Health conditions studied
1
Description of health condition studied
stress and coping
ICD-10 code
F43
ICD-10 code description
Neurotic, stress-related and somatoform disorders
Primary outcomes
1
Description
stress
Timepoint
in the first three days of admission and again two weeks later.
Method of measurement
PSS:NICU
2
Description
Coping
Timepoint
in the first three days of admission and again two weeks later.
Method of measurement
The Brief Cope
Secondary outcomes
empty
Intervention groups
1
Description
control group: mothers who have signed a written informed consent and filled demographic data form, Parental Stress Scale and The Brief Cope questionnaire in the first three days of admission and again two weeks later.
Category
Behavior
2
Description
Intervention group: intervention group: after necessary explanations about study aims to mothers, and filling written contest, in first three days of admission, demographic data form, Parental Stress Scale and The Brief Cope questionnaire should be filled with participant and group discussion meetings should be held between mothers, infant specialist, head nurse, charge nurse and researcher with themes about the environment and personnel of neonatal intensive care unit, conditions and specifications of premature infants, alternative methods of feeding premature infants, common problems in premature infants, routine care of premature infants and mothers concerns regarding the baby, in group with 6-10 individuals, twice a week, 60 minutes per session, for two weeks; after the last session mothers will fill parenting stress and The Brief Cope questionnaire.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash and Hospital, Affiliated to Tehran University of Medical Sciences.