mHealth-delivered Music Breathing Therapy to Enhance Resilience and Improve Quality of Life of Caregivers of Children Newly Diagnosed With Cancer: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Resilience
研究概览
简要总结
This proposed pilot randomised controlled trial aims to examine the effect of mobile health-delivered music breathing therapy in enhancing resilience, reducing psychological distress and caregiver strain, and improving the coping and quality of life of parental caregivers of children newly diagnosed with cancer.
详细描述
Parents of children with cancer experience considerable stress and distress from the time of their child's life-threatening diagnosis. Music therapy, for example, music breathing therapy, has been increasingly used as a nonpharmacological care strategy in the healthcare field. Music breathing therapy is an adaptation of the Bonny Method of Guided Imagery and Music. It has demonstrated promising potential for enhancing resilience and alleviating psychological distress among diverse populations, including women with complex post-traumatic stress disorder, individuals with work-related stress and caregivers of dementia patients. However, it is unclear whether this is a feasible and acceptable approach to enhance resilience, reduce psychological distress, and improve the quality of life of Chinese caregivers of children newly diagnosed with cancer.
Aims:
- To assess the effects of a mobile health-delivered music breathing therapy in enhancing resilience, reducing psychological distress (i.e., depression, anxiety, and stress) and caregiver strain, and improving coping and quality of life of parental caregivers of children newly diagnosed with cancer
- To determine the feasibility (in terms of recruitment rates, dropout rates, engagement rates, randomization process, and intervention delivery mode), and acceptability of the intervention.
Hypotheses:
It is hypothesized that compared with caregivers who receive usual care, those who receive the mHealth-delivered music breathing therapy will report higher levels of resilience (primary outcome), lower levels of psychological distress (i.e., depression, anxiety, and stress) and caregiver strain, better coping and quality of life at the 2-month (immediately after intervention) and 6-month follow-ups.
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)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parental caregivers (the primary caregiver; either mother or father) who
- •has a child (aged under 19 years) who has been diagnosed with cancer at least 2 months but not more than 12 months prior.
- •can read and communicate in Chinese (Cantonese or Mandarin)
- •has Internet access through any mobile device (e.g., a cell phone, tablet or laptop with camera and microphone features).
- •is willing to download and use Zoom as the intervention delivery platform.
排除标准
- •has a child who has been diagnosed with cancer and has major comorbid conditions and/or who is receiving end-of-life care.
- •is caring for more than one child with a chronic or critical illness or caring for another family member with a chronic illness.
- •is currently participating in any interventions or additional counselling services.
- •has a diagnosed mental illness, cognitive impairment or learning problem, and/or is taking regular psychotropic medications
结局指标
主要结局
Resilience
时间窗: 6-month after baseline
The Chinese version of the Connor-Davidson Resilience Scale will be used to assess the caregivers' levels of resilience. This scale consists of 25 items, rated on a 5-point Likert scale from 0 (not true at all) to 4 (true nearly all of the time). A higher total score indicates a higher level of resilience.
次要结局
- Feasibility outcomes - intervention engagement/adherence rate(Change from recruitment to 6-month follow-up)
- Psychological distress (i.e., depression, anxiety and stress)(2-month and 6-month after baseline)
- Acceptability(2-month follow-up (immediately after intervention))
- Caregiver strain(2-month and 6-month after baseline)
- Feasibility outcomes - Retention rate(Change from recruitment to 6-month follow-up)
- Acceptability - Satisfaction(2-month follow-up (immediately after intervention))
- Coping response(2-month and 6-month after baseline)
- Caregiver's quality of life(2-month and 6-month after baseline)
- Feasibility outcomes - recruitment rate(Change from recruitment to 6-month follow-up)
研究者
Cheung Tan
Assistant Professor
Chinese University of Hong Kong