Assessing the Effects of Implementation of Comfort Caring Model on Distress, Pain, and Hemodynamic Parameters of Children with Congenital Heart Disease Following the Cardiac Surgery

Determining the Effects of Implementation of Comfort Caring Model on Distress, Pain, and Hemodynamic Parameters of Children with Congenital Heart Disease Following the Cardiac Surgery

In this study, 50 children with congenital heart disease,which have open heart surgery,are selected according to entrance criteria. Participants are randomly divided into intervention and control groups. For sampling, random blocking sampling is used. In the intervention group interventions begin for each sample immediately after surgery and upon entering the cardiac care unit of children, according to comfort theory ,that provided at three levels of relief, ease and transcendence in the form of four dimensions of physical, environmental, psycho Spiritual and SocioCultural. A care plan is being developed and used during the intervention period to take care of the child. This program is reviewed in any shift. The control group carries out post-operative care, this care is based on in-patient policies and in-patient care protocols related to nursing care after surgery for pediatric cardiopulmonary abnormalities. Same Nurses care for children in both intervention and control groups, with the difference that they perform routine care in the control group and act in the intervention group according to the care plan developed according to the comfort theory. The intervention period for Every child will be 72 hours "beginning of the study, after 24, 48 and 72 hours" during this time three variables including psychological distress, pain and hemodynamic conditions of the patient, including vital signs, arterial blood oxygenation, serum lactate levels, mean arterial pressure, and central venous pressure are measured in both intervention and control groups.

This study is a clinical trial of two randomized groups for children who are admitted to the pediatric intensive care unit of Shahid Rajaee Hospital after surgery.

Inclusion criteria :child with cardiac abnormalities Parental satisfaction for participate in the study after undergo open heart surgery Lack of chromosomal abnormalities and mental retardation Non-treatment with neuromuscular blockers drugs Age of the child: from 28 days until the end of two years having no history of previous hospitalization and performing surgery for the first time having a CV line Connection to the mechanical ventilation device at the time of admission and separation within the first 24 hours after surgery;Exclusion criteria: Death of a child Dissatisfied parents to continue implementing a care method based on the comfort theory Incidence of unpredictable effects after surgery

This study will be conducted on children with congenital heart disease after heart surgery in a pediatric intensive care unit. After surgery when the children come to pediatric care unit from operation room , children who are eligible for entry and exit criteria are selected and randomly assigned to intervention and control groups. In the intervention group, nursing care based on comfort care theory is performed in three levels of relief, ease and transcendence in the form of four dimensions of physical, environmental, psych-spiritual, and sociocultural. The control group will receive usual post-operative care. Their care program will be based on in-patient policies and in-patient care protocols related to nursing care after surgery for pediatric cardiopulmonary abnormalities. Caregiver nurses are the same in both groups, with the difference that they care based on usual care program in the control group, and in the intervention group, care is based on a care plan designed according comfort theory.

The outcome of a care program based on comfort theory on pain, psychiatric disturbance and some hemodynamic parameters of children including vital signs, arterial blood oxygenation, serum lactate levels, arterial pressure, and central venous pressure are investigated.

This research, which is a master's degree dissertation, will be conducted as a research project at the University of Nursing and Midwifery Faculty of Tehran University of Medical Sciences, and all costs will be paid by the University.

In this research, random blocking sampling method is used. The researcher selects his samples from eligible children at a specified time interval. Assignment of samples is done in two experimental and control groups by random method and the completion of the samples is continued. Block random sampling is a randomized method that ensures that at each point in a research, roughly equal numbers of participants are assigned to all the comparison groups. To randomly assign samples to test groups and Random blocking control is the best method and it is possible to achieve the same number of samples in groups in sequential or sequential sampling at any time point of the study. The number of blocks based on the sample size determined according to the pilot study .

There is no program for publishing participant data file.