The main objectives:
1- To determine and compare the stress level of parents in the intervention and control groups on the 3rd day after the admission of the premature infant to the neonatal intensive care unit.
2- To determine and compare the stress level of parents in the intervention and control groups on the 10th day after the admission of the premature infant to the neonatal intensive care unit.
3- To determine and compare the stress level of the intervention group on the 3rd and 10th day after the admission of the premature infant to the neonatal intensive care unit.
4-To determine and compare the stress level of the control group on the 3rd and 10th day after the admission of the premature infant to the neonatal intensive care unit.
Design: A single-blind study
Methods: Samples are selected in the control and intervention groups. The stress level is compared in both groups after the intervention, which is training. The control group receives the routine clinical care.
Inclusion criteria: Literacy, no history of stressful experiences such as divorce, no history of infants’ hospitalization in a neonatal intensive care unit, no history of psychiatric medication؛ no history of drug abuse.
Exclusion criteria: Babies who die for any reason or are discharged earlier than 10 days and infants whose parents are not willing to continue cooperating with the researchers.
Intervention: Training happens in the intervention group specifically for both parents with a greater emphasis on their parental roles.
The main outcome variable: The main variable in this project is parental stress which the researcher is trying to reduce through training them and strengthening their parental role.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201605131788N17
Registration date:2016-11-15, 1395/08/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-15, 1395/08/25
Registrant information
Name
Leili Borimnejad
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6150 4212
Email address
borimnej@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, iran University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Parental Education Emphasizing the Parental Role on the Stress of Parents with an Infant Admitted to Neonatal Intensive Care Units
Public title
The Effect of Parental Education on the Stress of Parents with an Infant Admitted to Neonatal Intensive Care Units
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria of the study are as follows: Literacy; having no stressful experience, such as divorce, death of relatives, and so forth in the previous three months; having no history of admitting the infant to NICU; having no history of using psychiatric medications; .
Exclusion criteria: infants who died from any cause " babies who were discharged earlier than ten day؛ infants whose parents do not demonstrate a willingness to continue to cooperate with the investigator.
Age
From 17 years old to 34 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In the research training of parents as dedicated to each family. Group training is not considered. For training needs analysis in the first fathers of FSS tool has been used.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Iran University of Medical Sciences
Street address
Sidet to the martyr Motahhari Hospital St. martyr Yassami , Vali Asr Ave. City *
City
Tehran
Postal code
1996713883
Approval date
2016-01-06, 1394/10/16
Ethics committee reference number
IR.IUMS.REC.1394.9311451005
Health conditions studied
1
Description of health condition studied
Stress
ICD-10 code
f43.1
ICD-10 code description
Arises as a delayed or protracted response to a stressful event or situation (of either brief or long duration) of an exceptionally threatening or catastrophic nature, which is likely to cause pervasive distress in almost anyone. Predisposing factors, suc
Primary outcomes
1
Description
Stress
Timepoint
The first baby dresses for measuring parental stress is the third day of the second measure is the tenth day hospital stay
Method of measurement
Pss standard tools to help measure the amount of stress that it is done is done validity reliability .
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: from the beginning of July eligible for inclusion in the study 36 parents were selected to participate in the intervention group The full explanation of the study was to parents, then their written consent to participate in the project was completed. On the third day of hospitalization of children in the questionnaire (PSS: NICU) was completed by both parents. The distance between the third and tenth days of hospitalization in infants in the two sessions of face to face training class was held for two hours. This class includes training parents in cases where the stress was more on them. The issues that parents need to know to keep your baby . Finally, a practical class meeting was held with the replica or the baby to bug fixed. The distance between the third and tenth days of hospitalization in infants in a special section for parents by telephone, telegram and email were in contact with the researche.
Category
Behavior
2
Description
Control group : 36 parents for a month and a half has Inclusion criteria were selected for the control group. Authorities first full explanation of the study parents were simple language. After written consent was signed by parents participating in the study, On the third day in the intensive care unit NICU parents were enrolled. In these days of stress questionnaire ( PSS: NICU) was completed by them.Then, without intervention and only doing routine infant hospitalized again on the tenth day of this questionnaire (PSS: NICU) was completed.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
AliAsghar hospital
Full name of responsible person
Rabeeh Ghavami
Street address
Street Vahid Dastgerdi, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Ali Javad Moosavi
Street address
Besides Milad Tower, Hemmat Highway, Vice Chancellor for Research and Technology
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery , Iran University of Medical Sciences
Full name of responsible person
Dr. Leili Borimnejad
Position
PhD / Deputy School of Nursing
Other areas of specialty/work
Street address
Sidet to the martyr Motahhari Hospital St. martyr Yassami , Vali Asr Ave. City *
City
Thehran
Postal code
1997713883
Phone
+98 21 8888 2885
Fax
Email
l.borimnejad@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery , Iran University of Medical Sciences
Full name of responsible person
Dr , Naima Seyedfatemi
Position
PhD
Other areas of specialty/work
Street address
Sidet to the martyr Motahhari Hospital St. martyr Yassami , Vali Asr Ave. City *
City
Tehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
Email
nseyedfatemi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery , Iran University of Medical Sciences
Full name of responsible person
Dr. Leili Borimnejad
Position
PHD
Other areas of specialty/work
Street address
Sidet to the martyr Motahhari Hospital St. martyr Yassami , Vali Asr Ave. City *
City
Thehran
Postal code
1996713883
Phone
+98 21 8888 2885
Fax
+98 19196713883
Email
l.borimnejad@gmail. com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)