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Sponsored by: |
Sue Ryder Care |
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Information provided by: | Sue Ryder Care |
ClinicalTrials.gov Identifier: | NCT00220688 |
Randomised controlled trial of acupressure wrist bands for hospice in-patients suffering from terminal cancer who are troubled by nausea and vomiting.
Condition | Intervention |
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Cancer |
Device: Acupressure Wristbands |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Does Acupressure Help Reduce Nausea and Vomiting in Palliative Care Patients? |
Estimated Enrollment: | 10 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | October 2006 |
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:
4.3 Exclusion criteria
5. OUTCOME MEASURES
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, Bedfordshire | |
Sue Ryder Care St. John's Hospice | |
Moggerhanger, Bedfordshire, United Kingdom, MK44 3RJ |
Principal Investigator: | Paul Perkins, MB BCh MRCP | Sue Ryder Care St. John's Hospice |
Study ID Numbers: | SRC1 |
Study First Received: | September 16, 2005 |
Last Updated: | March 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00220688 History of Changes |
Health Authority: | United Kingdom: National Health Service |
nausea vomiting palliative acupressure |
Signs and Symptoms Vomiting Signs and Symptoms, Digestive Nausea |
Signs and Symptoms Vomiting Signs and Symptoms, Digestive |