- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07067034
- Original Trial
Nurse-Led Intervention (Riddikulus) to Reduce Anxiety in University Students (RNI)
The Riddikulus Nursing Intervention: A Brief, Nurse-Led Intervention to Reduce Student Anxiety in a Randomized Controlled Study
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Izmir, Turkey (Türkiye), 35100
- Ege University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Undergraduate student at the School of Foreign Languages, Ege University during the study period
- No history of repeating an academic year
- No hearing or visual impairments
- No prior psychiatric diagnosis
- Not currently undergoing psychiatric treatment or therapy
- A score between 16 and 25 on the Beck Anxiety Inventory (BAI), indicating moderate anxiety
- Voluntary participation with signed informed consent
Exclusion Criteria:
- Failure to attend the intervention session
- Withdrawal of voluntary consent at any time
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
Participants in this group received no intervention.
They completed the same outcome measures at the same time points as the intervention group, but did not receive any psychological or nursing-based session.
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|
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Experimental: Riddikulus Intervention Group
Participants in this group received a one-session, metaphor-based psychosocial nursing intervention.
The intervention involved identifying anxiety-related personal metaphors and restructuring them into less distressing or humorous mental images under the guidance of a trained academic nurse.
|
A one-session, nurse-led psychosocial intervention designed to reduce anxiety in university students.
Participants identified personal metaphors related to their anxiety and were guided to reconstruct them into less distressing, humorous, or calming mental images.
The intervention was delivered in a structured format by an academic nurse trained in therapeutic communication
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in anxiety level measured by Beck Anxiety Inventory (BAI)
Time Frame: Baseline, Immediately Post-Intervention, 4-Week Follow-Up
|
The Beck Anxiety Inventory (BAI) was used to assess clinical anxiety symptoms.
It is a 21-item self-report instrument, with higher total scores reflecting higher levels of anxiety.
The Beck Anxiety Inventory (BAI) ranges from 0 to 63, with higher scores indicating greater levels of anxiety
|
Baseline, Immediately Post-Intervention, 4-Week Follow-Up
|
|
Change in anxiety level measured by Visual Analog Scale (VAS)
Time Frame: Baseline, Immediately Post-Intervention
|
Anxiety was assessed using a 0-10 Visual Analog Scale (VAS), with higher scores indicating greater anxiety.
Measurements were taken before the intervention, immediately after, and two weeks following the session.
Lower scores reflect reduced levels of anxiety.
|
Baseline, Immediately Post-Intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-2T/44
- 1919B012205498 (Other Grant/Funding Number: TÜBİTAK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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