Saman, Yuliya
Pascual-Vera, Belén
Corberán, Marta
Arnáez, Sandra
Roncero, María
García-Soriano, Gemma
Article History
Received: 27 March 2024
Accepted: 3 April 2024
First Online: 9 April 2024
Declarations
:
: The authors assert that all procedures contributing to this study comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008. All procedures involving human subjects/patients were approved by the Ethics Committee of Research in Humans of the Universitat de Valènica (Spain) on March 14, 2023 (register code: 2557724), and it was registered in Clinicaltrials.gov on September 4, 2023 (Amendments: 4; last amendment on March 18, 2024). Identifier: NCT06033391 (). Any modification will be informed on Clinicaltrials.gov.Regarding participants’ consent, participants will be informed about the basics of the study and the potential benefits. Informed consent of the participants will be obtained after the nature of the procedures has been fully explained. Only those who provide the written consent, signed by the participant and their parent or legal guardian, will be included in the study. They will also be reminded that they can withdraw their consent at any point to terminate their participation and that anonymity and confidentiality is ensured. Regarding the potential risks of the study, no risks are expected. Nevertheless, in case of adverse events (e.g. discomfort while reading the statements of the application or the items of the questionnaires) individualized assistance will be offered. If necessary, specialized services will be provided.
: Not applicable.
: The authors declare no competing interests.