Nurse-Led Intervention (Riddikulus) to Reduce Anxiety in University Students

NCT07067034 | Completed

• 2 other identifiers: 23-2T/441919B012205498
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Nurse-led Supportive Care; Nursing Interventions

Keywords

Anxiety; University Students; Psychosocial Nursing Intervention; brief intervention

Outcome Measures

Primary Outcomes (2)

• Change in anxiety level measured by Beck Anxiety Inventory (BAI)

  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)

  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

Study Arms (2)

Riddikulus Intervention Group

EXPERIMENTAL

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.

Behavioral: Ridikullus Nursing İntervention

control group

NO INTERVENTION

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.

Interventions

Ridikullus Nursing İntervention BEHAVIORAL

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

Riddikulus Intervention Group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Failure to attend the intervention session
• Withdrawal of voluntary consent at any time

Sponsors & Collaborators

• Ege Miray Topcu: lead

Study Sites (1)

Ege University

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Group allocation was blinded to the investigators and care providers during participant assignment. Randomization codes were prepared by an independent person who did not take part in data collection or intervention delivery. After group assignment, participants and researchers were aware of the allocations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Assistant Ege University

Model Details: Participants were randomly assigned to either the intervention group, which received the Riddikulus Nursing Intervention, or the control group, which received no intervention. Each participant remained in their assigned group throughout the study. Anxiety levels were assessed at three time points: before, immediately after, and at follow-up.

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 15, 2025
• Study Start: December 16, 2023
• Primary Completion: December 10, 2024
• Study Completion: December 29, 2024
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon publication of primary results
• Access Criteria: Qualified researchers who provide a methodologically sound proposal may request access to de-identified individual participant data, the study protocol, and the statistical analysis plan. Data will be shared via secure institutional email after obtaining approval from the principal investigator and the ethics committee.

Locations

TU (1)