Hypnosedation in Relaxing Patients Undergoing Breast Cancer Surgery
NCT ID: NCT03012399
Last Updated: 2025-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2017-03-07
2027-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (hypnosedation)
Patients undergo hypnosedation performed by a mind-body specialist before surgery begins and continuing until after surgery is complete.
Hypnosedation
Undergo hypnosedation
Questionnaire Administration
Ancillary studies
Group II (verbal support)
Patients speak to a mind-body specialist before surgery and prior to receiving general anesthesia.
Questionnaire Administration
Ancillary studies
Verbal Support
Speak with min-body specialist
Interventions
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Hypnosedation
Undergo hypnosedation
Questionnaire Administration
Ancillary studies
Verbal Support
Speak with min-body specialist
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to read, speak, and write English or Spanish
Exclusion Criteria
* Significant pain during core biopsy as reported by the patient
* Received neoadjuvant chemotherapy, any autoimmune or immunological disease or taking any immune suppression drugs
* Plastic surgery involvement for oncoplastic reconstruction
* If surgery is likely greater than 3 hours
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Lorenzo Cohen
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2018-01241
Identifier Type: REGISTRY
Identifier Source: secondary_id
2016-0599
Identifier Type: OTHER
Identifier Source: secondary_id
2016-0599
Identifier Type: -
Identifier Source: org_study_id
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