AnxietyRNINCT07067034
Nurse-Led Intervention (Riddikulus) to Reduce Anxiety in University Students
A study testing Ridikullus Nursing İntervention in people with Anxiety and Nurse-led Supportive Care, run by Ege Miray Topcu at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Anxiety, Nurse-led Supportive Care, Nursing Interventions
- What is being tested?
- Ridikullus Nursing İntervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Dec 2023to 29 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Failure to attend the intervention session
- Withdrawal of voluntary consent at any time
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Riddikulus Nursing Intervention: A Brief, Nurse-Led Intervention to Reduce Student Anxiety in a Randomized Controlled Study
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.
Read the 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.
- Conditions
- Anxiety, Nurse-led Supportive Care, Nursing Interventions
- Being tested
- Ridikullus Nursing İntervention
- Keywords
- Anxiety, University Students, Psychosocial Nursing Intervention, brief intervention
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridikullus Nursing İnterventionBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline, Immediately Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start16 Dec 2023
- Primary completion10 Dec 2024
- Study completion29 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege Miray Topcu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ege Miray Topcu, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067034
- Sponsor's protocol ID
- 23-2T/44
- Other IDs
- 1919B012205498
- Acronym
- RNI
- Status last verified
- Sep 2025
- First submitted
- 4 Jul 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data including age, gender, Beck Anxiety Inventory (BAI) scores, and Visual Analog Scale (VAS) scores collected at baseline, immediately post-intervention, and 4-week follow-up will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Riddikulus Nursing Intervention: A Brief, Nurse-Led Intervention to Reduce Student Anxiety in a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07067034
- Acronym / sponsor ID
- RNI / 23-2T/44
- Conditions
- Anxiety, Nurse-led Supportive Care, Nursing Interventions
- Keywords
- Anxiety, University Students, Psychosocial Nursing Intervention, brief intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ege Miray TopcuUniversity, hospital or other
- Study start
- 16 Dec 2023 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 29 Dec 2024 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Riddikulus Intervention Group | Experimental | Behavioral: Ridikullus Nursing İnterventionParticipants 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. |
| 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Failure to attend the intervention session
- Withdrawal of voluntary consent at any time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ridikullus Nursing İnterventionA 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 | Behavioural | Riddikulus Intervention Group |
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data including age, gender, Beck Anxiety Inventory (BAI) scores, and Visual Analog Scale (VAS) scores collected at baseline, immediately post-intervention, and 4-week follow-up will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ridikullus Nursing İntervention in people with Anxiety and Nurse-led Supportive Care, run by Ege Miray Topcu at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in anxiety level measured by Beck Anxiety Inventory (BAI) (time frame: Baseline, Immediately Post-Intervention, 4-Week Follow-Up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.