Determining and comparing the mean scores of post-traumatic stress disorder and aggression in parents of babies with congenital anomalies before, immediately and one month after the intervention in two experimental and control groups
Design
A clinical trial with an intervention and control group will be conducted as a block randomization, a blind strain, phase 3 on 74 parents
Settings and conduct
Chamran, Al-Zahra and Imam Hossein hospitals in Isfahan. The revised event impact of event and trait anger questionnaire on the first day and the perceived social support questionnaire, coping with stress and parents' stress measurement in the neonatal intensive care unit will be answered by the parents on the third day after the end of the intervention and one month after the end of the intervention. After collecting the questionnaires, the intervention will be implemented for the parents of the intervention group.
Participants/Inclusion and exclusion criteria
Entry criteria for post-traumatic stress disorder score above 24 and exclusion criteria for congenital anomalies requiring emergency surgery, absence and non-participation of parents in 1 or more sessions
Intervention groups
The intervention of the family-centered support educational program based on four steps (information exchange, self-efficacy promotion, self-confidence (self-esteem) and evaluation) during 5 daily sessions to parents in the form of teaching care for babies with abnormalities, participation in baby care, facilitating communication and mutual support Couples and psychoeducation about stress will be provided, and the control group will receive usual routine care
Main outcome variables
The independent variable of the educational support program for parents is of qualitative and nominal type, the dependent variables of psychological consequences of parents (PTSD and aggression) are of quantitative type
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220605055080N1
Registration date:2022-09-10, 1401/06/19
Registration timing:prospective
Last update:2022-09-10, 1401/06/19
Update count:0
Registration date
2022-09-10, 1401/06/19
Registrant information
Name
Fateme Vaez
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 902 936 8800
Email address
fateme0vaez@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of a family-centered care on the aggression and Post-traumatic stress disorder (PTSD) in parents with congenital anomalies’ infants
Public title
The effectiveness of a family-centered care on the aggression and Post-traumatic stress disorder (PTSD) in parents with congenital anomalies’ infants
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Post-traumatic stress disorder score above 24
Parents with a baby with any congenital abnormality requiring hospitalization in the neonatal intensive care unit
Literate to read and write
Parents without any mental disorder or history of taking psychiatric drugs
Absence History of substance abuse in parents
Exclusion criteria:
Death of the baby during the intervention
Congenital abnormalities requiring emergency surgery
Discharge of the baby during the intervention
Occurrence of a stressful incident while studying
Absence and non-participation of parents in 1 or more sessions
Dissatisfaction and unwillingness of the baby's family to continue cooperating with the researcher at every stage of the study
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Before starting the study, we will refer to the samples and explain the study to them, and after obtaining informed consent, they will be randomly assigned to the control or intervention group. Participants will not be informed whether the participant is currently in the intervention or control group. Also, the data will be coded so that the statistician will not be informed of the control or intervention group of the data.
Placebo
Not used
Assignment
Other
Other design features
The selected samples will be assigned to the control or intervention group by block randomization. This method will continue until the number of samples reaches the desired number of samples.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Central headquarters, Isfahan University of Medical Sciences and Health Services, Hazar Jarib St.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2022-08-27, 1401/06/05
Ethics committee reference number
IR.MUI.NUREMA.REC.1401.067
Health conditions studied
1
Description of health condition studied
Post-traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)
Primary outcomes
1
Description
The average score of post-traumatic stress disorder changes in parents of babies with congenital malformation is different in the control and test groups after the intervention.
Timepoint
before the start of the intervention and one month after the end of the intervention
Method of measurement
Revised Weiss and Marmer Impact of Event Questionnaire (IES-R)
Secondary outcomes
1
Description
The average score of aggression changes in the parents of babies with congenital anomalies is different in the control and test groups after the intervention.
Timepoint
before the start of the intervention and one month after the end of the intervention
Method of measurement
Spielberger Trait Anger Questionnaire (STAXI-2)
Intervention groups
1
Description
Intervention group: This group will be subjected to the intervention of the family-oriented educational-support program based on four steps (information exchange, self-efficacy promotion, self-confidence (self-esteem) and evaluation) during 5 sessions; In this way, providing daily training to parents in the form of caring for babies with abnormalities, participation in baby care, facilitating communication and mutual support of couples, and psychological training regarding the stress associated with the presence of fathers and mothers of babies with abnormalities hospitalized in the intensive care unit. will be. In addition, an educational pamphlet will be provided to them. Family-centered care will be done with the presence of parents and the researcher in the breastfeeding room and the neonatal intensive care unit next to the baby. The researcher will receive the necessary training for counseling from the research consultant. The phone and SMS system will be used during the study period to resolve the questions and concerns of the parents.
Category
Other
2
Description
Control group: Parents of infants in the control group will receive routine care from the neonatal intensive care unit of Chamran, Al-Zahra and Imam Hossein (AS) hospitals in Isfahan, and no intervention will be performed on them. After the end of the intervention and one month after the end of the intervention, the Revised Weiss and Marmer Event Impact Questionnaire (IES-R) and the Spielberger Trait-State Anger Questionnaire (STAXI-2) will be completed for mothers in each control group. The phone and SMS system will be used during the study period to solve the questions and concerns of parents.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital, Isfahan
Full name of responsible person
Alireza Hosseini
Street address
Shahid Chamran Heart Training and Research Center, َAfter Shahristan Bridge, Third Mushtaq St.
City
Isfahan
Province
Isfehan
Postal code
81583-88997
Phone
+98 31 3260 0961
Email
chamran@mui.ac.ir
Web page address
https://chamran.mui.ac.ir/
2
Recruitment center
Name of recruitment center
Isfahan, Imam Hossein Hospital
Full name of responsible person
Mehrdad Memarzadeh
Street address
Imam Hossein (AS) Children's Educational and Therapeutic Center, Before Esteghlal Square, Imam Khomeini Street (RA), Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8195163381
Phone
+98 31 3386 6266
Fax
+98 31 3386 8286
Email
emamhossein_hospital@mui.ac.ir
Web page address
https://ehuch.mui.ac.ir/
3
Recruitment center
Name of recruitment center
Isfahan, Al-Zahra Hospital
Full name of responsible person
Mehrdad Nowrozi
Street address
Al-Zahra Medical Education Center, Safeh Blvd, Shahid Kishori Highway, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Fax
+98 31 3669 1510
Email
alzahra@mui.ac.ir
Web page address
https://alzahra.mui.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Kianpour
Street address
Research Centers of the Faculty of Nursing and Midwifery, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hazar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7621
Fax
+98 31 3669 9398
Email
nmrc@nm.mui.ac.ir
Web page address
https://mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?