Stefano Liguori1, Massimiliano Stacchini2, Daniele Ciofi2, Nicole Olivini3, Sofia Bisogni3, Filippo Festini4. 1. Tuscan Regional Health System, Tuscany, Italy. 2. Meyer Children's Hospital, Florence, Italy. 3. Department of Health Sciences, University of Florence, Florence, Italy. 4. Meyer Children's Hospital, Florence, Italy3Department of Health Sciences, University of Florence, Florence, Italy.
Abstract
IMPORTANCE: Effective methods to reduce children's preoperative anxiety (such as giving information beforehand, organizing a tour of the operating room [OR] before the intervention, and incorporating clown physicians) may be difficult to implement for some hospitals, as they are time-consuming and expensive and require hospital staff to be performed. OBJECTIVE: To test the effectiveness of Clickamico, an app that shows clown physicians giving a comical and informative tour of the OR, for reducing preoperative anxiety in children. DESIGN, SETTING, AND PARTICIPANTS: This unblinded randomized clinical trial included 40 children aged 6 to 11 years undergoing a planned surgical intervention at a third-level Italian pediatric hospital from December 2013 to September 2014 randomized into experimental (n = 20) and control (n = 20) groups. INTERVENTIONS: The experimental intervention was a 6-minute video showing 2 clown physicians visiting the OR and explaining to each other what is in the OR in a joking way. The video was shown on a tablet to children in the experimental group the afternoon preceding a planned surgical procedure. The control intervention was the standard informative intervention regarding the surgical procedure the next day. MAIN OUTCOMES AND MEASURES: The main outcome was preoperative anxiety. Preoperative anxiety was measured before the experimental and control interventions and immediately before entering the OR using the modified Yale Preoperative Anxiety Scale (m-YPAS). RESULTS: The experimental and control groups were homogeneous with regard to age (mean [SD] age, 8.8 [2.5] vs 8.6 [2.2] years), sex (female, 11 [55.0%] vs 9 [45.0%]), parents' age (mean [SD] age, 41.8 [6.2] vs 41.3 [5.0] years), and previous surgical procedures (already underwent surgical procedure, 9 [45.0%] vs 10 [50.0%]). The initial mean (SD) m-YPAS scores were 37.3 (21.7) and 37.1 (13.8) for the experimental and control groups, respectively; the mean (SD) m-YPAS scores when entering the OR were 33.0 (18.4) and 48.6 (15.9), respectively (P = .009). The mean (SD) difference between the m-YPAS score at the first and second measurements of each participant was -2.8 (7.2) in the experimental group and 10.7 (10.8) in the control group. The 13.5-point difference between these averages was statistically significant (P = .003). CONCLUSIONS AND RELEVANCE: The app was effective in reducing preoperative anxiety in Italian children admitted to an Italian National Health System pediatric hospital and may act as a substitute for staff-provided interventions, allowing possible reductions of hospital costs. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01688115.
RCT Entities:
IMPORTANCE: Effective methods to reduce children's preoperative anxiety (such as giving information beforehand, organizing a tour of the operating room [OR] before the intervention, and incorporating clown physicians) may be difficult to implement for some hospitals, as they are time-consuming and expensive and require hospital staff to be performed. OBJECTIVE: To test the effectiveness of Clickamico, an app that shows clown physicians giving a comical and informative tour of the OR, for reducing preoperative anxiety in children. DESIGN, SETTING, AND PARTICIPANTS: This unblinded randomized clinical trial included 40 children aged 6 to 11 years undergoing a planned surgical intervention at a third-level Italian pediatric hospital from December 2013 to September 2014 randomized into experimental (n = 20) and control (n = 20) groups. INTERVENTIONS: The experimental intervention was a 6-minute video showing 2 clown physicians visiting the OR and explaining to each other what is in the OR in a joking way. The video was shown on a tablet to children in the experimental group the afternoon preceding a planned surgical procedure. The control intervention was the standard informative intervention regarding the surgical procedure the next day. MAIN OUTCOMES AND MEASURES: The main outcome was preoperative anxiety. Preoperative anxiety was measured before the experimental and control interventions and immediately before entering the OR using the modified Yale Preoperative Anxiety Scale (m-YPAS). RESULTS: The experimental and control groups were homogeneous with regard to age (mean [SD] age, 8.8 [2.5] vs 8.6 [2.2] years), sex (female, 11 [55.0%] vs 9 [45.0%]), parents' age (mean [SD] age, 41.8 [6.2] vs 41.3 [5.0] years), and previous surgical procedures (already underwent surgical procedure, 9 [45.0%] vs 10 [50.0%]). The initial mean (SD) m-YPAS scores were 37.3 (21.7) and 37.1 (13.8) for the experimental and control groups, respectively; the mean (SD) m-YPAS scores when entering the OR were 33.0 (18.4) and 48.6 (15.9), respectively (P = .009). The mean (SD) difference between the m-YPAS score at the first and second measurements of each participant was -2.8 (7.2) in the experimental group and 10.7 (10.8) in the control group. The 13.5-point difference between these averages was statistically significant (P = .003). CONCLUSIONS AND RELEVANCE: The app was effective in reducing preoperative anxiety in Italian children admitted to an Italian National Health System pediatric hospital and may act as a substitute for staff-provided interventions, allowing possible reductions of hospital costs. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01688115.
Authors: Robin Eijlers; Bram Dierckx; Lonneke M Staals; Johan M Berghmans; Marc P van der Schroeff; Elske M Strabbing; René M H Wijnen; Manon H J Hillegers; Jeroen S Legerstee; Elisabeth M W J Utens Journal: Eur J Anaesthesiol Date: 2019-10 Impact factor: 4.330
Authors: Jie Li; Peishan Ning; Peixia Cheng; David C Schwebel; Yang Yang; Xiang Wei; Jieyi He; Wanhui Wang; Ruotong Li; Guoqing Hu Journal: J Med Internet Res Date: 2021-01-29 Impact factor: 5.428