Effect of Music Breathing, a Programme Based on Mindful Breathing and Music Therapy for Promoting Sense of Coherence in Young People: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 290
- 主要终点
- Sense of coherence: change from pre-intervention to post-intervention in sense of coherence
研究概览
简要总结
The goal of this experimental study is to test the effects of Music Breathing (MB) in promoting a sense of coherence among young people.
The main questions it aims to answer are:
- What is the effect of a MB programme on personal resources (i.e., SOC, coping self-efficacy, emotion regulation and mindfulness) compared with the control condition in young people?
- What is the effect of a MB programme on stress reduction (i.e., depression, anxiety and stress, and salivary cortisol levels) compared with the control condition in young people? • • What is the effect of a MB programme on mental well-being compared with the control condition in young people?
- What is the relationship between SOC, coping self-efficacy, emotion regulation and mindfulness?
Participants will receive a MB programme in 6 weekly sessions and weekly home practice. The programme includes:
- meditative breathing;
- breathing with music listening;
- drawing a mental image of the breathing practice; and
- sharing and processing of the experience
详细描述
The proposed study will evaluate the effect of the Music Breathing (MB) programme on young people's sense of coherence in promoting coping with stress.
In the proposed randomised controlled trial, a sample of 290 young people (aged 18-30) will be recruited and allocated randomly into either the experimental or placebo control group. Participants in the experimental group will participate in a 6-week MB programme that will include music therapy and mindful breathing guided by a certified music therapist.
The following objectives are proposed:
- To examine the effect of a MB programme on promoting personal resources in young people;
- To examine the effect of a MB programme on reducing stress-related symptoms in young people; and
- To examine the effect of a MB programme on promoting mental well-being in young people.
This is a two-arm, parallel randomised controlled trial (RCT). Randomisation involving computer-generated two-digit random numbers (even and odd) (Excel 2007, Microsoft, Redmond, WA, USA) will be used to allocate participants in sequence to either the intervention group or control group in a 1:1 ratio after they have provided consent to participate. The allocation will be blinded to the participants and the data analyst. The random allocation will be conducted by a research assistant who will not be involved in the intervention and data analysis. Participants in the experimental arm will receive a 6-week MB programme. Participants in the control arm will placebo control programme and will be blinded to the study details. Data will be collected from both groups at three time points: before-intervention (T0), after-intervention (week 6; T1) and 1-month follow-up (week 10; T2), except the salivary cortisol levels which will be assessed at T0 and T1.
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
- Single (Outcomes Assessor)
盲法说明
A research team member will be masked when performing data analysis
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
- •moderate stress level measured with perceived stress scale (PSS-10) >or =14-26
- •a liking for music
排除标准
- •diagnosed with an acute mental problem;
- •participants under the influence of drugs that affect the nervous system;
- •having previous experience with imagery evoked by music and meditations where music is played.
结局指标
主要结局
Sense of coherence: change from pre-intervention to post-intervention in sense of coherence
时间窗: Pre- to post-intervention (10 weeks)
The 13-item Chinese version of the Sense of Coherence Scale (C-SOC-13) ranges from 1 to 7. Higher scores indicate greater levels of sense of coherence.
次要结局
- Salivary cortisol(post-intervention at week 6)
- Depression, anxiety and stress: change from pre-intervention to post-intervention in depression, anxiety and stress(Pre- to post-intervention (10 weeks))
- Coping self-efficacy: change from pre-intervention to post-intervention in coping self-efficacy(Pre- to post-intervention (10 weeks))
- Mindfulness: change from pre-intervention to post-intervention in mindfulness(Pre- to post-intervention (10 weeks))
- Subjective general well-being; change from pre-intervention to post-intervention in subjective general well-being(Pre- to post-intervention (10 weeks))
- Emotion regulation: change from pre-intervention to post-intervention in emotion regulation(Pre- to post-intervention (10 weeks))
研究者
Winnie CHENG Lai Sheung
Professor of Practice
Caritas Institute of Higher Education