Clinical trial NCT05778994: Use of Intorus to Control Anxiety Before Exams in Students at the University of Extremadura
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: STUDENT
Anxiety Disorders
Keywords: STUDENTS
ANXIETY
OCCUPATIONAL THERAPY
Lead sponsor: University of Extremadura
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: 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.

Exclusion Criteria:

* Not meeting the inclusion criteria
* Not wanting to participate in the study

Primary outcomes:
measure: Changes in the BECK anxiety questionnaire over 3 months
timeFrame: Measures before starting the intervention. through study completion, an average of 3 months.
Secondary outcomes:
measure: Changes in the Perceived self-efficacy scale in academic situations
timeFrame: Measures before starting the intervention. through study completion, an average of 3 months.
measure: Changes in the questionnaire for the assessment of anxiety before exams
timeFrame: Measures before starting the intervention. through study completion, an average of 3 months.
Other outcomes:
measure: Participant satisfaction questionnaire
timeFrame: Through study completion, an average of 3 months
Locations:
city: Caceres
country: Spain
facility: Blanca Gonzalez Sanchez
Study officials:
affiliation: Universidad de Extremadura
name: Blanca González Sáchez, Doctor
role: PRINCIPAL_INVESTIGATOR
References: