]>
IRCT20220605055080N1 IRCT 2022-09-10 Esfahan University of Medical Sciences The effectiveness of a family-centered care on the aggression and Post-traumatic stress disorder (PTSD) in parents with congenital anomalies’ infants The effectiveness of a family-centered care on the aggression and Post-traumatic stress disorder (PTSD) in parents with congenital anomalies’ infants 2022-09-23 anticipated 74 Complete https://irct.ir/trial/64784 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Education/Guidance, 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, 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. 4 Post-traumatic stress disorder. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Fateme Vaez
Forozan 8th Alley, Arghvan St, Ferdowsi Square, Goldasht East.
Khorramabad Iran (Islamic Republic of) 6819765996 +98 66 3341 8247 fateme0vaez@gmail.com Esfahan University of Medical Sciences scientific Faramarz Kalhor
Nursing and Midwifery College, Isfahan University of Medical Sciences and Health Services, Hazar Jarib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 7153 kalhor.faramarz@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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 no limit no limit Both 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 F43.1 Post-traumatic stress disorder (PTSD) Other N/A 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. 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. 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). 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). Esfahan University of Medical Sciences Approved 2022-08-27 Ethics committee of Isfahan University of Medical Sciences Central headquarters, Isfahan University of Medical Sciences and Health Services, Hazar Jarib St. Isfahan Isfehan Iran (Islamic Republic of)