The effect of the family presence on anxiety and agitation of patients under mechanical ventilation after open heart surgery: a randomized clinical trial.

Background: Family-centered care has been considered as a philosophy of care. Family presence in intensive care units (ICUs), especially in the acute phase of the disease is controversial. This study has been carried out in order to determine the effect of the family presence on anxiety and agitation in patients undergoing coronary artery bypass grafting (CABG).

Materials And Methods: In a clinical trial, 70 patients were randomly allocated into groups of experimental and control. In the experimental group, during the weaning process from the mechanical ventilation, a family member was present at the bedside. The degree of anxiety and Richmond's Agitation and Sedation Scale (RASS) were compared in seven consecutive time stages, including the time of entry into the ICU, the first respiratory drive, the family entrance, 20 min and 1 h after the presence of the family member, the time of extubation, and 1 h after extubation.

Results: There was a significant difference between the two groups in the mean scores of the anxiety scale in the first (P =0.008), second (P=0.002), and third stages (P =0.005). This difference was not significant in the fourth to seventh stages (P>0.05). As the baseline anxiety levels were different, a covariate adjustment was used for comparisons between treatments, adjusting the main analyses for baseline anxiety levels. Analysis showed that groups were not different. Also, there was no significant difference in the mean scores of RASS between the two experimental and control groups at any of the seven stages (P> 0.05).

Conclusion: According to the findings of the present study, the presence of a family member does not reduce the level of anxiety and agitation of patients undergoing cardiac surgery. However, it can be concluded that this intervention is feasible in acute and complex situations after open heart surgeries.

Trial Registration: This study has been registered in the Iranian Registry of Clinical Trials with the code IRCT201609014299N4 .