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Tracking Information | |||||
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First Received Date † | September 16, 2005 | ||||
Last Updated Date | March 9, 2007 | ||||
Start Date † | September 2005 | ||||
Current Primary Outcome Measures † |
1.Visual Analogue Scale of nausea measured every 6 hours. | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00220688 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
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? | ||||
Brief Summary | Randomised controlled trial of acupressure wrist bands for hospice in-patients suffering from terminal cancer who are troubled by nausea and vomiting. |
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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:
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. |
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Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Cancer | ||||
Intervention † | Device: Acupressure Wristbands | ||||
Study Arms / Comparison Groups | |||||
Publications * | 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. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 10 | ||||
Completion Date | October 2006 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United Kingdom | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00220688 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Sue Ryder Care | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Sue Ryder Care | ||||
Verification Date | March 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |