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

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ClinicalTrials.gov Identifier: NCT00220688
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : October 14, 2009
Sponsor:
Information provided by:
Gloucestershire Hospitals NHS Foundation Trust

Study Description
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Brief Summary:
Randomised controlled trial of acupressure wrist bands for hospice in-patients suffering from terminal cancer who are troubled by nausea and vomiting.

Condition or disease Intervention/treatment Phase
Cancer Device: Acupressure Wristbands Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients?
Study Start Date : September 2005
Study Completion Date : October 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 1.Visual Analogue Scale of nausea measured every 6 hours.

Secondary Outcome Measures :
  1. Duration of perceived nausea over preceding time period.
  2. Number of vomits per 24 hours.
  3. Volume of vomit per 24 hours.
  4. Adverse effects of acupressure.
  5. Number of doses of PRN anti-emetics.
  6. Measure of whether the patient felt the intervention helped at the end of the trial.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 18.
  • 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.
  • 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00220688


Locations
United Kingdom
Sue Ryder Care St. John's Hospice
Moggerhanger, Bedfordshire, United Kingdom, MK44 3RJ
Sponsors and Collaborators
Gloucestershire Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Paul Perkins, MB BCh MRCP Sue Ryder Care St. John's Hospice
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

ClinicalTrials.gov Identifier: NCT00220688     History of Changes
Other Study ID Numbers: SRC1
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: March 2007

Keywords provided by Gloucestershire Hospitals NHS Foundation Trust:
nausea
vomiting
palliative
acupressure

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms