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

NCT05778994 | Completed

• 1 other identifier: 2023.ALUMNOS.INTORUS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

STUDENT; Anxiety Disorders

Keywords

STUDENTS; ANXIETY; OCCUPATIONAL THERAPY

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in the Perceived self-efficacy scale in academic situations

  Measures before starting the intervention. through study completion, an average of 3 months.

• Changes in the questionnaire for the assessment of anxiety before exams

  Measures before starting the intervention. through study completion, an average of 3 months.

Other Outcomes (1)

• Participant satisfaction questionnaire

  Through study completion, an average of 3 months

Study Arms (2)

EXPERIMENTAL

EXPERIMENTAL

Group that performs therapy with intorus

Device: INTORUS

CONTROL

NO INTERVENTION

Group without intervention

Interventions

INTORUS DEVICE

Exercise protocol with intorus

EXPERIMENTAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Not wanting to participate in the study

Sponsors & Collaborators

• University of Extremadura: lead

Study Sites (1)

Blanca Gonzalez Sanchez

Cáceres, 10001, Spain

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Blanca González Sáchez, Doctor

  Universidad de Extremadura

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DOCTOR. PRINCIPAL INVESTIGATOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: March 22, 2023
• Study Start: February 1, 2023
• Primary Completion: March 1, 2023
• Study Completion: July 31, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)