The REST (randomised evaluation of sleeping with a toy or comfort item) trial: a protocol for an online, randomised trial of comfort item use on sleep quality in children.

ABSTRACT: Randomised controlled trials (RCTs) are the gold standard for evaluating healthcare interventions. Participatory research, in which the public is engaged in research activities, enhances their understanding of trials but requires innovative strategies to reach diverse populations, particularly children. This article outlines the design of the REST (Randomised Evaluation of Sleeping with a Toy or comfort item) trial, a child-led study investigating whether sleeping with a comfort item affects sleep quality in children compared to not using one. The REST trial was created with children aged 7 to 12 through The Kid's Trial, an online initiative where children co-design and co-conduct a randomised trial. The REST trial is a two-arm, pragmatic, superiority RCT. Children worldwide participate fr

SUBMITTER: Lepage S 

PROVIDER: S-EPMC12702047 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature