Nausea | Alternative Approaches for Nausea Control
Nausea research study
What is the primary objective of this study?
216 Chemotherapy-naïve, female breast cancer patients about to begin chemotherapy and who expect to have nausea, will be entered. Participants will be randomized to one of three study arms: Arm 1: control; Arm 2: Expectancy-neutral handout + Expectancy-neutral MP3+ acupressure bands; Arm 3: Expectancy-enhancing handout + Expectancy-enhancing MP3 + acupressure bands. Hypothesis: Acupressure bands provided with the relaxation MP3 will be effective in controlling chemotherapy-induced nausea
Who is eligible to participate?
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Acupressure bandsBilateral acupressure wrist bands
Other:Expectancy-neutral handoutThe expectancy neutral handout has neutral information regarding the acupressure bands
Behavioral:Expectancy-neutral MP3Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery.
Other:Expectancy-enhancing handoutThe expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands
Behavioral:Expectancy-enhancing MP3Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery. It also has expectancy-enhancing information regarding the acupressure bands.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Arm 1 - Standard Care OnlyPatients will receive standard care only
Arm 2 - Expectancy-neutral ArmPatients receive: Expectancy-neutral handout Expectancy-neutral MP3 Acupressure bands
Arm 3 - Expectancy-enhancing ArmPatients receive: Expectancy-enhancing handout Expectancy-enhancing MP3 Acupressure bands
Start Date: November 2012
Completed Date: May 16, 2017
Primary Outcome: Patient Report Nausea Diary
Study sponsors, principal investigator, and references
Principal Investigator: Joseph A Roscoe, Ph.D.
Lead Sponsor: University of Rochester
Collaborator: National Center for Complementary and Integrative Health (NCCIH)