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临床试验/NCT05778994
NCT05778994已完成不适用

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

University of Extremadura2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Changes in the BECK anxiety questionnaire over 3 months

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Not meeting the inclusion criteria
  • Not wanting to participate in the study

结局指标

主要结局

Changes in the BECK anxiety questionnaire over 3 months

时间窗: 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

次要结局

  • Changes in the questionnaire for the assessment of anxiety before exams(Measures before starting the intervention. through study completion, an average of 3 months.)
  • Changes in the Perceived self-efficacy scale in academic situations(Measures before starting the intervention. through study completion, an average of 3 months.)

研究者

发起方
University of Extremadura
申办方类型
Other
责任方
Principal Investigator
主要研究者

Blanca González Sanchez

DOCTOR. PRINCIPAL INVESTIGATOR

University of Extremadura

研究点 (2)

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