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

Sponsor

Sue Ryder Care (Other)

Overall Status

Unknown status

CT.gov ID

NCT00550251

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nausea Vomiting	Device: Acupressure Wrist Bands (Sea-Bands) Device: Placebo wristbands	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2010

Anticipated Primary Completion Date :

Jul 1, 2018

Anticipated Study Completion Date :

Jul 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of PRN Doses of anti-emetics needed [3 days]

Secondary Outcome Measures

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. [3 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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, or history of use of acupressure by a close relative.
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.
Patients who are unable to read or comprehend the questionnaire or Visual Analogue Scale.