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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05778994
Other study ID # 2023.ALUMNOS.INTORUS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2023
Est. completion date July 31, 2023

Study information

Verified date November 2023
Source University of Extremadura
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 31, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
INTORUS
Exercise protocol with intorus

Locations

Country Name City State
Spain Blanca Gonzalez Sanchez Caceres

Sponsors (1)

Lead Sponsor Collaborator
University of Extremadura

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other 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
Primary 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 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 a = .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.
Secondary 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.
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