Ignite Creation Date:
2024-05-06 @ 9:33 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03012399
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2017-01-04
Brief Title:
Hypnosedation in Relaxing Patients Undergoing Breast Cancer Surgery
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Biobehavioral Effects of Hypnosis During Breast Cancer Surgery
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial studies how well hypnosedation works in relaxing and reducing the need for general anesthesia in patients who are undergoing breast cancer surgery Hypnosedation is a technique that places patients under conscious sedation where they remain awake and numbed during surgery and involves the use of words and images to help patients relax and to affect their thoughts about what is happening during surgery
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA016672 | NIH | M D Anderson Cancer Center | httpsreporternihgovquickSearchP30CA016672 |
| NCI-2018-01241 | REGISTRY | None | None |
| 2016-0599 | OTHER | None | None |