Research of Music Therapy in the Development of Persons With Special Needs
试验速览
- 阶段
- 不适用
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- subjective stress perception
研究概览
简要总结
The goal of the planned Randomized Control Trial is to explore the effect of vibroacoustic therapy on acute stress of university students. The theoretical framework of the study is based on biopsychosocial model of stress and multimodal approach to measurement. The trial is designed as single-blinded, placebo-controlled, with participants individually randomized into two parallel-groups, including equal randomization and blocked allocation of participants. 420 participants are all full-time university students (18-30 years) and will be divided into two groups: an experimental group (receiving low vibrations combined with music) and a control group (only music without low-frequency sounds). For both groups acute stress response will be measured by spectral analysis of heart rate variability (HRV SA), galvanic skin response (GSR), salivary cortisol, standardized psychological questionnaires - visual analogue scales for stress (VAS-stress) and Perceived Stress Scales-10, Czech version (PSS-10). It is expected that the experimental group will demonstrate a lower level of stress response that will be measured by higher activity of parasympathetic activity, lower level of skin resistance, lower level of salivary cortisol and lower subjective perception of stress. If vibroacoustic therapy turns out to be effective, it can be viewed as safe, student-friendly and inexpensive prevention of stress-related health problems and promote the health of students in the course of university education.
详细描述
Primary objective: to explore whether application of vibroacoustic therapy has more significant effect on eliminating acute stress response in university students than music alone.
Research question: "Does the application of vibroacoustic therapy (low frequency vibration with music) show a more significant effect on decreasing an acute stress response (measured by HRV SA, GSR, salivary cortisol) and perception of stress (measured on VAS) in university students compared to listening to music without technologically modified low-vibrations?"
Participants: The recruitment of suitable research participants will be carried out among students studying at Faculty of Education at Palacky University in Olomouc, Czech Republic, provided that all inclusive criteria are met. Participants will be recruited by three researchers via mail and personal contact with students at the start of each of two semesters of one academic year. Only students with medium or high levels of acute stress will participate on the research experiment (level of stress measured by PSS-10, min. 20 points are required from participants). Recruiting process will be coordinated and overseen by a recruitment coordinator. Sequentially numbered, opaque, sealed envelopes will be used as a mechanism for allocation concealment. The allocation sequence will be generated at a remote workplace by a specialist not participating in enrollment and assignment of participants for the intervention.
It is a parallel group, two arms, superiority trial with 1.1. allocation ratio. Equal blocked randomization (with block size 8) with stratification according to the gender will be used here. The randomization scheme will determine which persons will be placed in the intervention group and the control group (placebo) The randomization will be implemented by a computerized random number generator (program Sealed Envelope).
The intervention is triple-blinded (blinded will be participants, statisticians as well as outcome measurements). Considering one-shot character of research experiment in every participant possibility of emergency unblinding has not been considered, nor systematic plans to promote participants´ retention and complete follow-up have not been created.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •participants want to voluntarily participate in the study,
- •they are 18-30 years old,
- •they are of Czech or Slovak nationality,
- •full-time students.
排除标准
- •psychiatric diagnosis,
- •neurologic disease (e.g. epilepsy, cerebral palsy) or any known contraindication of vibro-acoustic therapy such as muscle hypotonia, angina pectoris, psychotic or acute post-traumatic and bleeding,
- •post-traumatic stress disorder,
- •perceived pain,
- •persons after sleep deprivation,
- •substance abuse (caffeine, nicotine) on the day of experiment and in case of strong addictive substances (alcohol, drugs) 1 day before the experiment,
- •increased physical activity on the day before the experiment,
- •menstruation on the day of the experiment,
- •moderate to high food intake on the day of the experiment.
结局指标
主要结局
subjective stress perception
时间窗: 1 day
Subjective stress perception measured by Visual Analogue Scales for Stress and Perceived Stress Scales-10, Czech version.
Salivary cortisol
时间窗: 1 day
Salivary cortisol to measure the level of cortisol by Salivette Cortisol.
Galvanic skin response
时间窗: 1 day
Galvanic skin response to measure the response of autonomous nervous system response measured by VLV Lab.
Spectral analysis of heart rate variability
时间窗: 1 day
Spectral analysis of heart rate variability to measure the response of autonomous nervous system response measured by VLV Lab.
次要结局
未报告次要终点
研究者
Jiří Kantor
Principal Investigator
Palacky University