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

May 3, 2018 updated by: Paul Perkins, Sue Ryder Care
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Gloucestershire
      • Cheltenham, Gloucestershire, United Kingdom, GL53 0QJ
        • Recruiting
        • Sue Ryder Care Leckhampton Court Hospice
        • Contact:
        • Principal Investigator:
          • Paul Perkins, MB BCh MRCP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Acupressure Bands
Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.
Device: Acupressure Wrist Bands (Sea-Bands)
Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.
Other Names:
  • Sea-Bands
Placebo Comparator: Placebo
Elasticated wrist bands without active bead.
Device: Placebo wristbands
Elasticated wrist bands without active bead.
Other Names:
  • Seaband Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of PRN Doses of anti-emetics needed
Time Frame: 3 days
3 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sue Ryder Care

Investigators

  • Study Director: Paul Perkins, MB Bch MRCP, Sue Ryder Care Leckhampton Court Hospice

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2018

Study Registration Dates

First Submitted

October 25, 2007

First Submitted That Met QC Criteria

October 25, 2007

First Posted (Estimate)

October 29, 2007

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 3, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SRC2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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