Nausea | Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? Formal Study
Nausea research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: 1. Have a diagnosis of advanced cancer with an estimated prognosis of less than 1 year but more than 3 days. 2. 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. 3. 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). 4. Can be male or female patients but must be over the age of 18. 5. Have signed a consent form prior to entering the study. 6. If patients are taking corticosteroids the dosage should be stable for 3 days before and during the trial. 7. Be thought to be well enough to complete the 3 day trial. Exclusion criteria: 1. Arm lymphoedema. 2. Weakness, fatigue or confusion sufficient that patient is unable to take part. 3. Previous history of acupuncture/acupressure for nausea or vomiting, or history of use of acupressure by a close relative. 4. History of Parkinsonism or Parkinsonism on examination. 5. Patients will not be enrolled if they are sharing a room with another patient taking part in the study. 6. Patients who are unable to read or comprehend the questionnaire or Visual Analogue Scale.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Acupressure Wrist Bands (Sea-Bands)Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.
Device:Placebo wristbandsElasticated wrist bands without active bead.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Acupressure BandsElasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.
PlaceboElasticated wrist bands without active bead.
Start Date: July 2010
Completed Date: July 2018
Primary Outcome: Number of PRN Doses of anti-emetics needed
Secondary Outcome: 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.
Study sponsors, principal investigator, and references
Principal Investigator: Paul Perkins, MB Bch MRCP
Lead Sponsor: Sue Ryder Care