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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nausea Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Acupressure Bands

Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.

Group Type ACTIVE_COMPARATOR

Acupressure Wrist Bands (Sea-Bands)

Intervention Type DEVICE

Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.

Placebo

Elasticated wrist bands without active bead.

Group Type PLACEBO_COMPARATOR

Placebo wristbands

Intervention Type DEVICE

Elasticated wrist bands without active bead.

Interventions

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Acupressure Wrist Bands (Sea-Bands)

Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.

Intervention Type DEVICE

Placebo wristbands

Elasticated wrist bands without active bead.

Intervention Type DEVICE

Other Intervention Names

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Sea-Bands Seaband Placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No