STUDENTNCT05778994
Use of Intorus to Control Anxiety Before Exams in Students at the University of Extremadura
A study testing INTORUS in people with STUDENT and Anxiety Disorders, run by University of Extremadura at 1 site in Spain.
Trial summary
The goal of this clinical trial is to assess the possible efficacy of the INTORUS device as an element to reduce test anxiety in university students. The main question[s] it aims to answer are: Can the INTORUS device be used as a tool to reduce anxiety? Once informed, those participants who meet the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STUDENT, Anxiety Disorders
- What is being tested?
- INTORUS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 31 Jul 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Students of the Degree in Occupational Therapy at the University of Extremadura.
- Students who are going to study the Degree in Occupational Therapy in person.
Who cannot join
- Not meeting the inclusion criteria
- Not wanting to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of the Intorus Device as a Therapeutic Tool for the Control of Anxiety Before the Exams in Occupational Therapy Students of the University of Extremadura
The goal of this clinical trial is to assess the possible efficacy of the INTORUS device as an element to reduce test anxiety in university students. The main question[s] it aims to answer are:
Can the INTORUS device be used as a tool to reduce anxiety? Once informed, those participants who meet the inclusion/exclusion criteria and sign the informed consent to participate in the study will be randomly divided into two groups. The randomization procedure will be carried out using the OxMaR (Oxford Minimization and Randomization) software.
All participants will be given the Sociodemographic Questionnaire, Self-efficacy Scale and anxiety questionnaire prior to the start of the study.
Read the detailed description
The population is made up of students of the Degree in Occupational Therapy during the 2nd semester of the 2022-2023 academic year.
The initial sample size will be approximately 70 participants.
- Process
Once informed, those participants who meet the inclusion/exclusion criteria and sign the informed consent to participate in the study will be randomly divided into two groups. The randomization procedure will be carried out using the Oxford Minimization and Randomization software.
All participants will be given the Sociodemographic Questionnaire, Self-efficacy Scale and anxiety questionnaire prior to the start of the study.
The participants of the experimental group will carry out a weekly exercise session with INTORUS aimed at reducing anxiety in the period between March 1, 2023 and May 10, 2023.
On the day of the final exam for the subject, all students will repeat the anxiety measurement questionnaire and the perceived self-efficacy scale minutes before the final exam for the subject.
Once the intervention period is over, a questionnaire will be passed to the professionals participating in the study to assess the usefulness of the device, the degree of satisfaction with it and the usefulness of the therapies applied.
- Conditions
- STUDENT, Anxiety Disorders
- Being tested
- INTORUS
- Keywords
- STUDENTS, ANXIETY, OCCUPATIONAL THERAPY
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INTORUSDevice
Exercise protocol with intorus
| Study group | Role | What they receive |
|---|---|---|
| EXPERIMENTAL | Experimental | Group that performs therapy with intorus Receives: Device: INTORUS |
| CONTROL | No intervention | Group without intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the BECK anxiety questionnaire over 3 months
Questionnaire to measure anxiety. The questionnaire consists of 21 questions, providing a range of scores between 0 and 63. The suggested cut-off points for interpreting the result obtained are as follows:
00-21 - Very low anxiety 22-35 - Moderate anxiety over 36 - Severe anxiety
Measured: Measures before starting the intervention. through study completion, an average of 3 months.
Secondary outcomes (2)
Changes in the Perceived self-efficacy scale in academic situations
Scale to measure participants' perceived self-efficacy in academic situations. the scale is structured with 10 items, wherein factorial loads are higher than .63 (with the exception of item 9); with high reliability α = .91 and temporal stability (10 weeks) r = .91. higher scores mean a worse outcome.
Measured: Measures before starting the intervention. through study completion, an average of 3 months.
Changes in the questionnaire for the assessment of anxiety before exams
Questionnaire to measure participants' level of test anxiety. a standardized measurement scale for test anxiety, consists of 20 items that separate worry and emotionality and, at the same time, yields total score of examination anxiety. higher scores mean a worse outcome.
Measured: Measures before starting the intervention. through study completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start1 Feb 2023
- Primary completion1 Mar 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for STUDENTStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca González Sanchez, University of Extremadura
- Investigators
- Blanca González Sáchez, Doctor, Principal investigator, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778994
- Sponsor's protocol ID
- 2023.ALUMNOS.INTORUS
- Status last verified
- Nov 2023
- First submitted
- 30 Jan 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Intorus Device as a Therapeutic Tool for the Control of Anxiety Before the Exams in Occupational Therapy Students of the University of Extremadura
- ClinicalTrials.gov ID
- NCT05778994
- Acronym / sponsor ID
- 2023.ALUMNOS.INTORUS
- Conditions
- STUDENT, Anxiety Disorders
- Keywords
- STUDENTS, ANXIETY, OCCUPATIONAL THERAPY
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 22 Mar 2023 (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.
The goal of this clinical trial is to assess the possible efficacy of the INTORUS device as an element to reduce test anxiety in university students. The main question[s] it aims to answer are:
Can the INTORUS device be used as a tool to reduce anxiety? Once informed, those participants who meet the inclusion/exclusion criteria and sign the informed consent to participate in the study will be randomly divided into two groups. The randomization procedure will be carried out using the OxMaR (Oxford Minimization and Randomization) software.
All participants will be given the Sociodemographic Questionnaire, Self-efficacy Scale and anxiety questionnaire prior to the start of the study.
Detailed description
The population is made up of students of the Degree in Occupational Therapy during the 2nd semester of the 2022-2023 academic year.
The initial sample size will be approximately 70 participants.
- Process
Once informed, those participants who meet the inclusion/exclusion criteria and sign the informed consent to participate in the study will be randomly divided into two groups. The randomization procedure will be carried out using the Oxford Minimization and Randomization software.
All participants will be given the Sociodemographic Questionnaire, Self-efficacy Scale and anxiety questionnaire prior to the start of the study.
The participants of the experimental group will carry out a weekly exercise session with INTORUS aimed at reducing anxiety in the period between March 1, 2023 and May 10, 2023.
On the day of the final exam for the subject, all students will repeat the anxiety measurement questionnaire and the perceived self-efficacy scale minutes before the final exam for the subject.
Once the intervention period is over, a questionnaire will be passed to the professionals participating in the study to assess the usefulness of the device, the degree of satisfaction with it and the usefulness of the therapies applied.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL | Experimental | Device: INTORUSGroup that performs therapy with intorus |
| CONTROL | No intervention | –Group without intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Students of the Degree in Occupational Therapy at the University of Extremadura.
- Students who are going to study the Degree in Occupational Therapy in person.
Key exclusion criteria (2 listed)
- Not meeting the inclusion criteria
- Not wanting to participate in the study
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 |
|---|---|---|
| INTORUSExercise protocol with intorus | Device | EXPERIMENTAL |
Primary outcome
Changes in the BECK anxiety questionnaire over 3 months
Time frame: Measures before starting the intervention. through study completion, an average of 3 months.
Questionnaire to measure anxiety. The questionnaire consists of 21 questions, providing a range of scores between 0 and 63. The suggested cut-off points for interpreting the result obtained are as follows: 00-21 - Very low anxiety 22-35 - Moderate anxiety over 36 - Severe anxiety
2 secondary outcomes
Changes in the Perceived self-efficacy scale in academic situations
Time frame: Measures before starting the intervention. through study completion, an average of 3 months.
Changes in the questionnaire for the assessment of anxiety before exams
Time frame: Measures before starting the intervention. through study completion, an average of 3 months.
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 1 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Blanca González Sáchez, Doctor principal investigator
Universidad de Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INTORUS in people with STUDENT and Anxiety Disorders, run by University of Extremadura at 1 site in Spain.
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 2 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 1 Dec 2023. 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 Spain. 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?
Changes in the BECK anxiety questionnaire over 3 months (time frame: Measures before starting the intervention. through study completion, an average of 3 months.). 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 1 Dec 2023.