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

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders; STUDENT
• Intervention / Treatment: Device: INTORUS

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Caceres, Spain, 10001
    • Blanca Gonzalez Sanchez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EXPERIMENTAL; Group that performs therapy with intorus	Device: INTORUS; Exercise protocol with intorus
No Intervention: CONTROL; Group without intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Measures before starting the intervention. through study completion, an average of 3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Measures before starting the intervention. through study completion, an average of 3 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant satisfaction questionnaire	Questionnaire to measure patient satisfaction with the protocol. higher scores mean a better outcome.	Through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: University of Extremadura
• Investigators: Principal Investigator: Blanca González Sáchez, Doctor, Universidad de Extremadura

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: ANXIETY; OCCUPATIONAL THERAPY; STUDENTS
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2023.ALUMNOS.INTORUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No