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

Primary Purpose

Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Acupressure Wristbands
Sponsored by
Gloucestershire Hospitals NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring nausea, vomiting, palliative, acupressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sue Ryder Care St. John's Hospice

Outcomes

Primary Outcome Measures

1.Visual Analogue Scale of nausea measured every 6 hours.

Secondary Outcome Measures

Duration of perceived nausea over preceding time period.
Number of vomits per 24 hours.
Volume of vomit per 24 hours.
Adverse effects of acupressure.
Number of doses of PRN anti-emetics.
Measure of whether the patient felt the intervention helped at the end of the trial.

Full Information

First Posted
September 16, 2005
Last Updated
October 13, 2009
Sponsor
Gloucestershire Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00220688
Brief Title
Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients?
Official Title
Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Gloucestershire Hospitals NHS Foundation Trust

4. Oversight

5. Study Description

Brief Summary
Randomised controlled trial of acupressure wrist bands for hospice in-patients suffering from terminal cancer who are troubled by nausea and vomiting.
Detailed Description
Pilot The study will be piloted with 10 patients to ensure that the protocol is acceptable to patients and to inform a formal power calculation for a larger study. Patients will be randomized to each arm according to a randomization programme at www.randomization.com. Arm 1 Instruction and placement of acupressure bands at the P6 acupuncture point bilaterally. This point is located 2 cun (a Chinese measurement equal to approximately 3cm) proximal to the midpoint of the transverse crease of the wrist between the tendons of palmaris longus and flexor carpi radialis. Arm 2 Instruction and placement of sham acupressure bands P6 acupuncture point bilaterally. Sham acupressure bands have no stud to stimulate P6. Patients may choose to have regular anti-emetics or a subcutaneous syringe driver after 24 hours if they are not happy with their level of nausea and vomiting. 4. STUDY POPULATION 4.1 Source and Number of Patients: Hospice in-patients. 10 patients for pilot. 4.2 Inclusion Criteria Patients must meet the following criteria to be eligible to participate in the study: 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. 4.3 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. 5. OUTCOME MEASURES Visual Analogue Scale of nausea measured every 6 hours. If patients are asleep they will not be waken for assessments overnight. Duration of perceived nausea over preceding time period. Number of vomits per 24 hours. Volume of vomit per 24 hours. Adverse effects of acupressure. Number of doses of PRN anti-emetics. Measure of whether the patient felt the intervention helped at the end of the trial. 6. QUANTITATIVE ANALYSIS This pilot will allow a formal power calculation to be performed to elucidate how many patients need to be randomized to the full study. Statistical analysis will be performed by Sarah Vowler at the Centre for Applied Medical Statistics.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer
Keywords
nausea, vomiting, palliative, acupressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
10 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Acupressure Wristbands
Primary Outcome Measure Information:
Title
1.Visual Analogue Scale of nausea measured every 6 hours.
Secondary Outcome Measure Information:
Title
Duration of perceived nausea over preceding time period.
Title
Number of vomits per 24 hours.
Title
Volume of vomit per 24 hours.
Title
Adverse effects of acupressure.
Title
Number of doses of PRN anti-emetics.
Title
Measure of whether the patient felt the intervention helped at the end of the trial.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Perkins, MB BCh MRCP
Organizational Affiliation
Sue Ryder Care St. John's Hospice
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sue Ryder Care St. John's Hospice
City
Moggerhanger
State/Province
Bedfordshire
ZIP/Postal Code
MK44 3RJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
1457233
Citation
Brown S, North D, Marvel MK, Fons R. Acupressure wrist bands to relieve nausea and vomiting in hospice patients: do they work? Am J Hosp Palliat Care. 1992 Jul-Aug;9(4):26-9. doi: 10.1177/104990919200900409.
Results Reference
result

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

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