Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? Formal Study
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Number of PRN Doses of anti-emetics needed
研究概览
简要总结
Pilot study completed - power calculation performed. Now formal double blind randomized study comparing active with placebo wristbands for nausea in palliative care patients to be carried out.
详细描述
Terminally ill hospice in-patients suffering with nausea will be randomized to active or placebo acupressure bands. The study will last 3 days and they will be allowed to continue regular or have PRN anti-emetics during the study.
Assessors and patients will both be blinded to whether they patients are receiving active or placebo bands.
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
- Double (Participant, 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
- •Have a diagnosis of advanced cancer with an estimated prognosis of less than 1 year but more than 3 days.
- •Describe their nausea as at least moderate on a Likert scale OR at have had at least one vomit per day for the last three days.
- •Have an underlying cause for their nausea which is thought to be irreversible OR the patient has made an autonomous choice not to proceed with treatment for any potentially reversible cause (for example surgery for obstruction or drainage of ascites).
- •Can be male or female patients but must be over the age of
- •Have signed a consent form prior to entering the study.
- •If patients are taking corticosteroids the dosage should be stable for 3 days before and during the trial.
- •Be thought to be well enough to complete the 3 day trial.
- •Exclusion criteria:
- •Arm lymphoedema.
- •Weakness, fatigue or confusion sufficient that patient is unable to take part.
- •Previous history of acupuncture/acupressure for nausea or vomiting, or history of use of acupressure by a close relative.
- •History of Parkinsonism or Parkinsonism on examination.
- •Patients will not be enrolled if they are sharing a room with another patient taking part in the study.
- •Patients who are unable to read or comprehend the questionnaire or Visual Analogue Scale.
排除标准
- 未提供
研究组 & 干预措施
Acupressure Bands
Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.
干预措施: Acupressure Wrist Bands (Sea-Bands) (Device)
Placebo
Elasticated wrist bands without active bead.
干预措施: Placebo wristbands (Device)
结局指标
主要结局
Number of PRN Doses of anti-emetics needed
时间窗: 3 days
次要结局
- Visual Analogue Scale of nausea; duration of perceived nausea; number of vomits per 24 hours; volume of vomit per 24 hours; adverse effects of acupressure; measure of whether the patient felt the intervention helped.(3 days)
研究者
Paul Perkins
Consultant in Palliative Medicine
Sue Ryder Care