Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

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Description Module


Ignite Creation Date: 2025-12-25 @ 2:28 AM
Ignite Modification Date: 2025-12-25 @ 2:28 AM
NCT ID: NCT07067034
Brief Summary: This randomized controlled trial investigates the effectiveness of the Riddikulus Nursing Intervention, a brief, low-cost, nurse-led strategy designed to reduce anxiety levels in university students. The intervention uses metaphor-based reflection and creative emotional flexibility techniques in a single-session format. A total of 36 participants were randomly assigned to intervention and control groups. Anxiety levels were measured using the Visual Analog Scale (VAS) and the Beck Anxiety Inventory (BAI) before and after the intervention. The study aims to evaluate whether this innovative, easily applicable approach can significantly reduce short-term perceived anxiety in young adults.
Detailed Description: This study investigates the effectiveness of a novel, low-cost, nurse-led psychological intervention called the Riddikulus Nursing Intervention, designed to reduce anxiety levels in university students with moderate anxiety. The intervention was inspired by a metaphorical coping scene from the Harry Potter film series and structured as a single-session, creative, and non-pharmacological approach. During the intervention, participants were asked to generate personal metaphors related to their anxiety and were guided in restructuring these metaphors into less distressing, humorous, or soothing mental images. The process was facilitated by an academic mentor trained in therapeutic communication. The study was conducted at the School of Foreign Languages of Ege University between December 2023 and June 2024. A total of 1100 students were invited, and 549 agreed to participate. Among students with moderate levels of anxiety, 36 participants were included and the study was completed with them. These participants were randomly assigned to intervention (n=17) and control (n=19) groups. Anxiety levels were assessed at three time points-pre-intervention, post-intervention, and follow-up-using the Visual Analog Scale (VAS) and the Beck Anxiety Inventory (BAI). Data analysis was performed with SPSS 25.0, and participant flow was reported using the CONSORT diagram. The results revealed a statistically significant reduction in VAS anxiety scores within the intervention group, with a large effect size. However, no significant differences were observed in BAI scores between the groups over time. These findings suggest that the Riddikulus Intervention may be particularly effective in reducing short-term, perceived anxiety in young adults. Participants also reported subjective improvements in emotional state and metaphor transformation following the session. This study highlights the feasibility and promise of brief, creative, nurse-led interventions for managing moderate anxiety in university settings. Further research with larger sample sizes, repeated sessions, digital delivery formats, and long-term follow-up assessments is recommended to validate and expand upon these findings.
Study: NCT07067034
Study Brief:
Protocol Section: NCT07067034