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

Sponsor
University of Extremadura (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05778994
Collaborator
(none)
60
1
2
5.9
10.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: INTORUS
N/A

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

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Feb 1, 2023
Actual Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Jul 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: EXPERIMENTAL

Group that performs therapy with intorus

Device: INTORUS
Exercise protocol with intorus

No Intervention: CONTROL

Group without intervention

Outcome Measures

Primary Outcome Measures

  1. Changes in the BECK anxiety questionnaire over 3 months [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

Secondary Outcome Measures

  1. Changes in the Perceived self-efficacy scale in academic situations [Measures before starting the intervention. through study completion, an average of 3 months.]

    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.

  2. Changes in the questionnaire for the assessment of anxiety before exams [Measures before starting the intervention. through study completion, an average of 3 months.]

    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.

Other Outcome Measures

  1. Participant satisfaction questionnaire [Through study completion, an average of 3 months]

    Questionnaire to measure patient satisfaction with the protocol. higher scores mean a better outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Blanca Gonzalez Sanchez Caceres Spain 10001

Sponsors and Collaborators

  • University of Extremadura

Investigators

  • Principal Investigator: Blanca González Sáchez, Doctor, Universidad de Extremadura

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Blanca González Sanchez, DOCTOR. PRINCIPAL INVESTIGATOR, University of Extremadura
ClinicalTrials.gov Identifier:
NCT05778994
Other Study ID Numbers:
  • 2023.ALUMNOS.INTORUS
First Posted:
Mar 22, 2023
Last Update Posted:
Mar 22, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Blanca González Sanchez, DOCTOR. PRINCIPAL INVESTIGATOR, University of Extremadura
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2023