Use of Intorus to Control Anxiety Before Exams in Students at the University of Extremadura
Primary Purpose
STUDENT, Anxiety Disorders
Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
INTORUS
Sponsored by
About this trial
This is an interventional prevention trial for STUDENT focused on measuring STUDENTS, ANXIETY, OCCUPATIONAL THERAPY
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
Sites / Locations
- Blanca Gonzalez Sanchez
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
EXPERIMENTAL
CONTROL
Arm Description
Group that performs therapy with intorus
Group without intervention
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05778994
First Posted
January 30, 2023
Last Updated
March 20, 2023
Sponsor
University of Extremadura
1. Study Identification
Unique Protocol Identification Number
NCT05778994
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
March 1, 2023 (Actual)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Extremadura
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STUDENT, Anxiety Disorders
Keywords
STUDENTS, ANXIETY, OCCUPATIONAL THERAPY
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EXPERIMENTAL
Arm Type
Experimental
Arm Description
Group that performs therapy with intorus
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
Group without intervention
Intervention Type
Device
Intervention Name(s)
INTORUS
Intervention Description
Exercise protocol with intorus
Primary Outcome Measure Information:
Title
Changes in the BECK anxiety questionnaire over 3 months
Description
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
Time Frame
Measures before starting the intervention. through study completion, an average of 3 months.
Secondary Outcome Measure Information:
Title
Changes in the Perceived self-efficacy scale in academic situations
Description
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.
Time Frame
Measures before starting the intervention. through study completion, an average of 3 months.
Title
Changes in the questionnaire for the assessment of anxiety before exams
Description
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.
Time Frame
Measures before starting the intervention. through study completion, an average of 3 months.
Other Pre-specified Outcome Measures:
Title
Participant satisfaction questionnaire
Description
Questionnaire to measure patient satisfaction with the protocol. higher scores mean a better outcome.
Time Frame
Through study completion, an average of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Blanca González Sáchez, Doctor
Organizational Affiliation
Universidad de Extremadura
Official's Role
Principal Investigator
Facility Information:
Facility Name
Blanca Gonzalez Sanchez
City
Caceres
ZIP/Postal Code
10001
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of Intorus to Control Anxiety Before Exams in Students at the University of Extremadura
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