Randomized Control Trial Access to an online video enhances the consent process, increases knowledge, and decreases anxiety of caregivers with children scheduled for inguinal hernia repair: A randomized controlled study ☆ Friederike Book a , Jan Goedeke a , Alicia Poplawski b , Oliver J. Muensterer a, ⁎ a Department of Pediatric Surgery, University Medicine of the Johannes Gutenberg University, Mainz, Germany b IMBEI Institute of Medical Biostatistics, Epidemiology and Informatics University Medicine of the Johannes Gutenberg University, Mainz, Germany abstract article info Article history: Received 15 September 2019 Accepted 29 September 2019 Key words: Inguinal hernia repair Informed consent Online video Anxiety Satisfaction Background: There is limited time within the clinical workflow of most pediatric surgeons to obtain a comprehen- sive, well informed consent. This study evaluates whether ad-lib access to an online video on the consent dia- logue enhances the consent process for inguinal hernia repair (IHR) in children. Methods: The study was approved by the state ethics board. A 6-min video of a consent speech on IHR was produced and uploaded to a nonpublic online channel, explaining the condition, procedure, complica- tions, and postoperative expectations. A total of 50 families were randomized to conventional, face-to-face consenting in clinic either with (intervention) or without (control) access to the online video. During their child's IHR, the parents were asked to complete the State–Trait–Anxiety Inventory (STAI), a modified Friedlander questionnaire on assessing knowledge sufficient to provide informed consent, and a validated satisfaction survey. Scores of the intervention and control group were statistically compared. Results: The intervention group demonstrated significantly decreased anxiety measured with the STAI (p = 0,026) and increased knowledge (p = 0,016) compared to controls. There was no difference in satisfaction (p = 0,557). Conclusion: Preoperatively providing access to an online consent video regarding IHR reduces anxiety and enhances knowledge without altering satisfaction level. Adjunct online videos are a useful tool to enhance the consent process. Type of study: Prospective randomized controlled trial. Level of evidence: Level I. © 2019 Elsevier Inc. All rights reserved. Modern medical ethics demand that prior informed consent must be obtained before performing any type of surgical procedure on a patient [1]. The term “informed” implies that the person giving con- sent understands the rationale for the procedure, alternatives, ad- vantages and disadvantages, risks and benefits, expected outcome, possible complications, as well as technical aspects of the procedure itself. Only then is an informed consent truly informed. Most often in pediatric surgery, the legal guardians provide consent in surrogate for their children. In the best of cases, the information is conveyed by the surgeon performing the procedure, or a surgeon from the team who is intimately involved in the case. Unfortunately, de- mands of increased productivity limit the contact time between the provider and the family in today's clinical workflow, resulting in an often overwhelming amount of information being transmitted in a very short time. Furthermore, the parents or guardians may just have learned about a diagnosis or that a procedure is indi- cated in their child, creating an emotional predicament that compro- mises reception for information provided during the consent process [2]. Several studies have shown that knowledge about medical procedures is insufficient to obtain informed consent [3–5]. A decade ago, Nwomeh et al. demonstrated that using a portable computer Journal of Pediatric Surgery 55 (2020) 18–28 ☆ How this paper will improve care: This study shows that providing parents with ac- cess to an online video on the consent talk regarding inguinal hernia repair decreases peri- operative anxiety and enhances knowledge. We propose that online videos should be available for other elective procedures as well. ⁎ Corresponding author at: Department of Pediatric Surgery, University Medicine Mainz, Langenbeckstrasse 1, 55131 Mainz, Germany. Tel.: +49 6131 17 3865; fax: +49 6131 17 6523. E-mail address: oliver.muensterer@unimedizin-mainz.de (O.J. Muensterer). https://doi.org/10.1016/j.jpedsurg.2019.09.047 0022-3468/© 2019 Elsevier Inc. All rights reserved. Contents lists available at ScienceDirect Journal of Pediatric Surgery journal homepage: www.elsevier.com/locate/jpedsurg