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Use of Intorus to Control Anxiety Before Exams in Students at the University of Extremadura

NCT ID: NCT05778994

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2023-07-31

Brief Summary

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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

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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

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STUDENT Anxiety Disorders

Keywords

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STUDENTS ANXIETY OCCUPATIONAL THERAPY

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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EXPERIMENTAL

Group that performs therapy with intorus

Group Type EXPERIMENTAL

INTORUS

Intervention Type DEVICE

Exercise protocol with intorus

CONTROL

Group without intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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INTORUS

Exercise protocol with intorus

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

* Not wanting to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Extremadura

OTHER

Sponsor Role lead

Responsible Party

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Blanca González Sanchez

DOCTOR. PRINCIPAL INVESTIGATOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Blanca González Sáchez, Doctor

Role: PRINCIPAL_INVESTIGATOR

Universidad de Extremadura

Locations

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Blanca Gonzalez Sanchez

Cáceres, , Spain

Site Status

Countries

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Spain

Other Identifiers

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2023.ALUMNOS.INTORUS

Identifier Type: -

Identifier Source: org_study_id