Efficacy of Hypno-ear-acupuncture on Insomnia in Advanced Cancer Patients: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Richards-Campbell Sleep Questionnaire (RCSQ)
研究概览
简要总结
This randomized controlled trial aims to test if a combination of medical hypnosis and ear acupuncture improves sleep quality in patients with advanced cancer during a hospital stay in a palliative care unit.
Patients submitted to our palliative care unit will receive a medical hypnosis and ear acupuncture on the second day of their stay. Sleep quality will be measured using validated patient-reported outcome measures at baseline and after 7 days. Additionally, the use of sleep medication will be documented as a secondary outcome.
The intervention will be compared to a sham medical hypnosis and ear acupuncture to see if the effect of the true intervention has a unique effect.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed cancer
- •RCSQ total score <25mm
- •ability to read and understand the questionnaires
- •ability to give informed consent
排除标准
- •pregnancy
- •language barrier (non German)
- •inability to give informed consent
- •hypacusis
- •radiographical verified brain metastases
- •diagnosed psychosis
结局指标
主要结局
Richards-Campbell Sleep Questionnaire (RCSQ)
时间窗: Baseline and after seven days
Change in Patient-reported outcome measure assessing the sleep quality on five sleep related items using a visual analoge scale Range: 0-100mm (Visual Analog Scale) Domains/items: 5 (Sleep depth, Sleep latency, Awakenings from sleep, Ability to return to sleep, Sleep quality) Total score: mean score of all 5 domains (0-100) Interpretation: higher scores reflect better sleep quality
次要结局
- Use of additional medication(From baseline to end of study (total seven days))
- Edmonton symptom assessment scale (ESAS)(Baseline and after seven days)
- Patient health questionnaire 9 (PHQ-9)(Baseline and after seven days)