Finding studies
Finding studies
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Lead
M.D. Anderson Cancer Center
With
PRIMARY OBJECTIVES: I. Determine the feasibility of conducting a randomized controlled trial (RCT) of hypnosedation (HS) during breast cancer surgery. SECONDARY OBJECTIVES: I. Assess the preliminary efficacy of HS with local anesthesia versus (vs) opioid based general anesthesia (GA) on reducing self-reported anxiety, pain, nausea, vomiting, cancer-related symptoms, and surgical complication rates. II. Preliminarily evaluate changes in immune markers (natural killer cell function, cytokines, and resolution of inflammatory response markers) and endocrine function (epinephrine, norepinephrine, and cortisol). III. Preliminarily identify changes in neurological activity as assessed through electroencephalogram (EEG) activity. IV. Preliminarily evaluate the group differences in medical costs. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients undergo hypnosedation performed by a mind-body specialist before surgery begins and continuing until after surgery is complete. GROUP II: Patients speak to a mind-body specialist before surgery and prior to receiving general anesthesia. After completion of study intervention, patients are followed up at days 1, 3, 5, 7, and 14.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted