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临床试验/NCT05171218
NCT05171218已完成不适用

The Effects of Music & Auditory Beat Stimulation on Anxiety

Toronto Metropolitan University2 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2020年7月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
163
试验地点
2
主要终点
Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)

研究概览

简要总结

Anxiety is a growing problem and has been steadily increasing, particularly in the adolescent and young adult populations in the past 24 years. Music and auditory beat stimulation (ABS) in the theta frequency range (4-7 Hz) are sound-based anxiety treatments that have been independently investigated in prior studies. Here, the anxiety-reducing potential of calm music combined with theta ABS was examined in a large sample of participants. Participants taking anxiolytics (n = 163) were randomly assigned to a single 24-minute session of sound-based treatment: combined (music & ABS), music-alone, ABS-alone, or pink noise (control). Pre- and post-intervention somatic and cognitive state anxiety measures (STICSA State) were collected along with trait anxiety (STICSA Trait), personality measures (Short Form Eysenck Personality Inventory) and musical preferences (Short Test of Music Preferences).

详细描述

In this study, the investigators examined and compared the effectiveness of ABS in the theta range, calm music playlist curated by an affective music recommendation system, and the combination of ABS and the same music to reduce anxiety and stress levels (as measured by the State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)) compared to a control condition (pink noise). Prior work has demonstrated that ABS and music both reduce anxiety when presented on their own. It is hypothesized that music with ABS will lead to significantly lower anxiety levels and increased calmness compared to the other experimental conditions. Approximately 163 participants were recruited from the Prolific online participant pool (https://www.prolific.co). The experiment was conducted on the Qualtrics survey platform, and the experimental treatment was provided with the LUCID Research App. After reading and agreeing with the consent form, participants provided their Prolific ID and then filled out the Short Test of Music Preferences (STOMP), Queen's Music Questionnaire, Anxiety coping method's questionnaire, Positive and Negative Affect Scale (PANAS), Self-Assessment Manikin (SAM), Eysenck Personality Questionnaire, and the State Trait Inventory of Cognitive and Somatic Anxiety (STICSA). Participants were also asked to list any medications currently being taken (including cannabis). Participants were then randomly assigned to one of four treatment groups: (1) music; (2) music and auditory beat stimulation (ABS); (3) auditory beat stimulation (ABS) alone; or (4) pink noise for 24 minutes. Participants then received instructions on how to download the LUCID Research app on their iOS device or access the LUCID Research App through a virtual machine using their computer. Participants listened to their randomly assigned treatment for 24 minutes. Participants then completed their post-intervention questionnaires which included: the STICSA state version, SAM and PANAS. The investigators' hypotheses were that the combined, music alone and ABS alone conditions would experience a greater reduction in somatic and cognitive state anxiety compared to the pink noise control condition. These hypotheses were pre-registered using the Open Science Framework (Registration DOI: https://doi.org/10.17605/OSF.IO/VHCA5) and were based upon previous studies showing that ABS and music listening are capable of reducing anxiety. The investigators had no specific predictions for moderate and high trait anxiety participants, but their pre-registration noted their intention to recruit from both of these populations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Adults (18+)
  • Must be taking anxiety medication
  • Self-identified normal hearing
  • No known cardiac issues
  • No known epilepsy/seizures
  • Have access to an iOS device (iPhone or iPad) to run the Research Application

排除标准

  • Adults younger than 18
  • Not taking anxiety medication
  • Have known cardiac issues
  • Do not have access to an iOS device (iPhone or iPad) to run the Research Application
  • Have known epilepsy/seizures

结局指标

主要结局

Anxiety: State Trait Inventory for Cognitive and Somatic Anxiety (STICSA)

时间窗: 24 minutes

The State Trait Anxiety Inventory for Cognitive and Somatic Anxiety has good reliability and validity as a measure of state and trait cognitive and somatic anxiety. The minimum score is 10 and the maximum is 40. Higher scores indicate higher anxiety (worse outcome). But in this study the post-intervention anxiety score is subtracted from the pre-intervention anxiety score, giving a measure of anxiety reduction. In the case of this anxiety reduction measure, higher anxiety reduction scores would indicate a better outcome.

次要结局

  • Mood: Positive and Negative Affect Scale (PANAS)(24 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Frank Russo

Professor

Toronto Metropolitan University

研究点 (2)

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