Examining the Effects of Binaural Beat Music on Sleep Quality, Heart Rate Variability, and Depression in Older People With Poor Sleep Quality in a Long-term Care Institution: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- HRV analyzer
研究概览
简要总结
Background:
Older people in long-term care institutions often have poor sleep quality and depression, which may negatively affect their health and welfare. Binaural beat music (BBM) has been proposed as a possible intervention. However, its effects on older people with poor sleep quality in long-term care institutions is still unclear.
Objective:
This study aimed to examine the effects of binaural beat music on sleep quality, heart rate variability, and depression in older people with poor sleep quality in a long-term care institution
Methods:
A single-blind randomized controlled trial design was employed and 64 older participants with poor sleep quality were recruited from a long-term care institution in Taiwan. Participants were randomized into the BBM group or control (sham) group (32 per group) and received 14 days of intervention. During the intervention period, participants in the experimental group listened to 20 minutes of Taiwanese Hokkien oldies embedded with BBM once in the morning and afternoon thrice a week. Participants in the control group only listened to Taiwanese Hokkien oldies. Questionnaires and heart rate variability analysis were used to assess participants' sleep quality, heart rate variability, and depressive symptoms.
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 (Participant)
入排标准
- 年龄范围
- 75 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria were participants who: were aged 65 years and older, had a PSQI score> 7, were able to understand questionnaire contents and communicate in Mandarin or Taiwanese Hokkien, stayed in institution for 1 month and more, and did not receive antidepressant within 3 months prior to and during the intervention.
排除标准
- •Exclusion criteria were those with hearing loss, history of bipolar disorder or schizophrenia diagnosed by a physician, and had an acute physiological disease, such as cold, fracture, or trauma.
结局指标
主要结局
HRV analyzer
时间窗: On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' long-term care institution and the test content was the same as the first test. It took about 5 minutes
HRV was used to measure heart rate variability, including five markers: (1) Mean heart rate; (2) SDNN: Standard deviation of all RR intervals, represent the physiological health of autonomic nervous system; the higher the SDNN, the better the physiological health of the autonomic nervous system; (3) nLF: Normalized low frequency, reflects sympathetic nervous activity. The higher the value, the greater the activity; (4) nHF: Normalized high frequency, reflects parasympathetic nervous activity. The higher the value, the greater the activity; (5) LF/HF, a marker reflecting sympathetic and parasympathetic nervous activity.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' long-term care institution and the test content was the same as the first test. It took about 10 minutes.
There were 18 questions in the PSQI, and participants used a self-rated method to fill in their sleep quality in the last month on a 4-point Likert scale. The total score range was 0-21 points. The higher the score, the poorer the sleep quality. This scale has seven dimensions, including: (1) Subjective sleep quality; (2) Sleep latency; (3) Sleep duration; (4) Sleep efficiency; (5) Sleep disturbances; (6) Daytime dysfunction; and (7) Use of sleep medication. PSQI had good validity and reliability(Tsai et al., 2005).
次要结局
- Geriatric Depression Scale (GDS)(On Day 14 of the intervention, the researchers conducted the posttest (second test) at the participants' long-term care institution and the test content was the same as the first test. It took about 5 minutes)
研究者
Yang Shang-Yu
Assistant professor
Asia University