Anxiety Disorders Clinical Trial
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
Verified date | November 2023 |
Source | University of Extremadura |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Blanca Gonzalez Sanchez | Caceres |
Lead Sponsor | Collaborator |
---|---|
University of Extremadura |
Spain,
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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