START NOW WebApp-promoting emotion regulation and resilience in residential youth care and correctional institutions: study protocol for a cluster randomized controlled trial.

BACKGROUND: Adolescents and young adults in residential care and correctional institutions face various challenges, leading to negative life outcomes. Implementation barriers within these institutions, such as limited financial and spatial resources, pose significant hurdles to providing necessary support. Web-based approaches address these challenges by offering cost-effective, accessible solutions. This study aims to assess the efficacy of a newly developed web-based version of the existing evidence-based START NOW skills training in fostering emotion regulation and resilience among institutionalized adolescents and young adults. We present the study protocol (Version 5, August 2023) of the trial titled "Implementation of an e-version of the skills training START NOW for promoting emotion regulation and resilience in residential youth care and correctional institutions". METHODS: The study is a monocentric, prospective, confirmatory randomized controlled trial with 150 institutionalized adolescents and young adults with a need to improve resilience (predefined cut-offs). Participating institutions will be randomized to one of three conditions: (i) 9-week web-based group training guided by a facilitator, (ii) 9-week web-based self-help training, (iii) and treatment as usual. The primary endpoint is the change in psychological flexibility, assessed by the Avoidance and Fusion Questionnaire for Youth score, from baseline to follow-up 12 weeks post skills training. Secondary objectives encompass assessing pre-post changes in psychological flexibility and other psychological health-related outcome measures in participating adolescents, young adults, and caretakers from baseline, to post training, and to 12- and 24-week follow-ups. DISCUSSION: This study evaluates the efficacy of START NOW as web-based training for institutionalized adolescents and young adults, providing valuable insights into web-based interventions and aiming to optimize support levels. TRIAL REGISTRATION {2A AND 2B}: ClinicalTrials.gov NCT05313581. Registered on 6 April 2022.

Virtual reality vs. tablet for procedural comfort using an identical game in children undergoing venipuncture: a randomized clinical trial.

Introduction: Recent research has explored the effectiveness of interactive virtual experiences in managing pain and anxiety in children during routine medical procedures, compared to conventional care methods. However, the influence of the specific technology used as an interface, 3-dimensions (D) immersive virtual reality (VR) vs. 2D touch screens, during pediatric venipuncture, remains unexamined. This study aimed to determine if immersive VR is more effective than a tablet in reducing pain and anxiety during short procedures. Methods: An interactive game was designed by clinicians and psychologists, expert in pain theory, hypnosis, and procedural pain and anxiety relief, and was tailored for both VR and tablet use. Fifty patients were randomly assigned to either the Tablet or VR group. The primary outcome measures were pain and anxiety levels during the procedure. Secondary outcome measures included the need for physical restraint, duration of the procedure, enjoyment levels, and satisfaction ratings from both parents and nurses. Results: Participants, in both groups, had low levels of pain and anxiety. Physical restraint was infrequently used, procedures were brief, and high satisfaction levels were reported by patients, parents, and nurses. Discussion: This study suggests that the type of technology used as a support for the game has a minimal effect on the child's experience, with both groups reporting low pain and anxiety levels, minimal physical restraint, and high enjoyment. Despite immersive VR's technological advancements, this study underscores the value of traditional tablets with well-designed interactive games in enhancing children's wellbeing during medical procedures. Clinical Trial Registration: [ClinicalTrials.gov], identifier [NCT05065307].