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Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? Formal Study

This study is currently recruiting participants.
Verified May 2017 by Paul Perkins, Sue Ryder Care
Sponsor:
ClinicalTrials.gov Identifier:
NCT00550251
First Posted: October 29, 2007
Last Update Posted: May 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Paul Perkins, Sue Ryder Care
October 25, 2007
October 29, 2007
May 11, 2017
July 2010
September 2017   (Final data collection date for primary outcome measure)
Number of PRN Doses of anti-emetics needed [ Time Frame: 3 days ]
Same as current
Complete list of historical versions of study NCT00550251 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 3 days ]
Same as current
Not Provided
Not Provided
 
Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? Formal Study
Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? Formal 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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
  • Nausea
  • Vomiting
  • Device: Acupressure Wrist Bands (Sea-Bands)
    Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.
    Other Name: Sea-Bands
  • Device: Placebo wristbands
    Elasticated wrist bands without active bead.
    Other Name: Seaband Placebo
  • Active Comparator: Acupressure Bands
    Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.
    Intervention: Device: Acupressure Wrist Bands (Sea-Bands)
  • Placebo Comparator: Placebo
    Elasticated wrist bands without active bead.
    Intervention: Device: Placebo wristbands
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
58
September 2017
September 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Paul Perkins, MB BCh MRCP +44 1242 230199 paul.perkins@suerydercare.org
United Kingdom
 
 
NCT00550251
SRC2
No
Not Provided
Not Provided
Paul Perkins, Sue Ryder Care
Sue Ryder Care
Not Provided
Study Director: Paul Perkins, MB Bch MRCP Sue Ryder Care Leckhampton Court Hospice
Sue Ryder Care
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP