NauseaNCT00550251
Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? Formal Study
A study testing Acupressure Wrist Bands (Sea-Bands) in people with Nausea and Vomiting, run by Sue Ryder Care at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Acupressure Wrist Bands (Sea-Bands)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Sue Ryder Care Leckhampton Court Hospice
Cheltenham, Gloucestershire, GL53 0QJ
Paul Perkins, MB BCh MRCP, +441242230199, paul.perkins@suerydercare.org
Paul Perkins, MB BCh MRCP
About this study
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.
Read the 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.
- Being tested
- Acupressure Wrist Bands (Sea-Bands), Placebo wristbands
- Keywords
- Nausea, Vomiting, Emesis, Palliative, Terminal, Cancer
- Medical subject headings
- Nausea, Vomiting, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupressure Wrist Bands (Sea-Bands)Device
Also called Sea-Bands
Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally.
Placebo wristbandsDevice
Also called Seaband Placebo
Elasticated wrist bands without active bead.
| Study group | Role | What they receive |
|---|---|---|
| Acupressure Bands | Active comparator | Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally. Receives: Device: Acupressure Wrist Bands (Sea-Bands) |
| Placebo | Placebo comparator | Elasticated wrist bands without active bead. Receives: Device: Placebo wristbands |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of PRN Doses of anti-emetics needed
Measured: 3 days
Secondary outcomes (1)
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2007 (estimated)
- Study startJul 2010
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sue Ryder Care
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Perkins, Sue Ryder Care
- Investigators
- Paul Perkins, MB Bch MRCP, Study director, Sue Ryder Care Leckhampton Court Hospice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00550251
- Sponsor's protocol ID
- SRC2
- Status last verified
- May 2018
- First submitted
- 25 Oct 2007
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? Formal Study
- ClinicalTrials.gov ID
- NCT00550251
- Acronym / sponsor ID
- SRC2
- Keywords
- Nausea, Vomiting, Emesis, Palliative, Terminal, Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Sue Ryder CareUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 29 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure Bands | Active comparator | Device: Acupressure Wrist Bands (Sea-Bands)Elasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally. |
| Placebo | Placebo comparator | Device: Placebo wristbandsElasticated wrist bands without active bead. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupressure Wrist Bands (Sea-Bands)Also: Sea-BandsElasticated wrist bands with active bead pressing on Pericardium 6 acupressure points bilaterally. | Device | Acupressure Bands |
| Placebo wristbandsAlso: Seaband PlaceboElasticated wrist bands without active bead. | Device | Placebo |
Primary outcome
Number of PRN Doses of anti-emetics needed
Time frame: 3 days
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Perkins, MB Bch MRCP study director
Sue Ryder Care Leckhampton Court Hospice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupressure Wrist Bands (Sea-Bands) in people with Nausea and Vomiting, run by Sue Ryder Care at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Perkins, MB BCh MRCP (+44 1242 230199, paul.perkins@suerydercare.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of PRN Doses of anti-emetics needed (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.