Background: Anxiety is a kind of emotional disorder caused by acute conditions or trigger. It is manifested in the components of the autonomic nervous system, for instance, stress, anxiety, nervosity, and discomfort. Most patients with anxiety are more active, nervous, and alert to various stimuli. Inappropriate management of early postoperative anxiety will not only prolong recovery but also increase the risk of other complications. We conduct a randomized clinical trial to investigate the influences of nursing visits against the preoperative anxiety and postoperative complications in patients undergoing laparoscopic cholecystectomy (LC).
Methods: This is a single center, placebo-controlled randomized trial, which will be performed from August 2020 to December 2020. The trial is performed in accordance with the SPIRIT Checklist for randomized studies. It is authorized by the Ethics Committee of Taizhou Hospital of Zhejiang Province (D20211-34). Two hundred patients undergoing LC will be included in this study. Patients are randomly divided into 2 groups: experiential group (n = 100) or control group (n = 100). The experimental group is given preoperative nursing visit to each patient 1 day before the operation, whereas the control group did not receive the preoperative nursing intervention. The patients in experience group also received education on the surgery team and the environment of operating room, the process of anesthesia, advantages of laparoscopic surgery, and the postoperative care from recovery room to discharge. The primary outcomes include State-Trait anxiety level and postoperative visual analogue scale. Secondary outcomes include total consumption of analgesics and postoperative complications.
Results: Figure (a) will show the comparison of outcomes between 2 groups.
Conclusion: The preoperative nursing visit may decrease the anxiety and the complications after operation in patients receiving LC.
Trial registration: This study protocol is registered in Research Registry (researchregistry5924).