Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010855
Status:
COMPLETED
Last Update Posted:
2008-08-06
First Post:
2001-02-02
Brief Title:
Nonpharmacologic Analgesia for Invasive Procedures
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Nonpharmacologic Analgesia for Invasive Procedures
Status:
COMPLETED
Status Verified Date:
2008-08
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:
Analgesics and sedatives administered to control distress from minimally invasive surgical procedures have limited effectiveness and serious side effects Unabated distress not only interferes with smooth progression of the ongoing procedure but can elicit adverse responses when patients need additional intervention The long-term objective of this research is to provide a safe and practical behavioral method for reducing cognitive and physiologic distress associated with invasive procedures Currently this method should benefit at least 8 million patients annually in the US Extrapolating the risk of intravenous conscious sedation to the number of invasive procedures performed annually we predict that 47000 patients will suffer serious cardiorespiratory complications and 2600 will die These numbers do not include effects of the psychological damage inflicted by poorly managed procedure-related stress on patients subsequent health behavior This application sets out to pursue three aims 1 Prospectively determine the impact of self-hypnotic relaxation on cognitive and physiologic distress during tumor embolizations 2 Prospectively determine the impact of self-hypnotic relaxation on distress in the postoperative period 3 Determine the impact of intraprocedural self-hypnotic relaxation on distress during subsequent tumor embolization We hypothesize that 1 Self-hypnotic relaxation decreases cognitive and physiologic distress during tumor embolizations 2 Self-hypnotic relaxation decreases cognitive and physiologic distress after tumor embolization when post-embolization ischemia is expected to induce painful stimuli and systemic distress 3 The beneficial effect of self-hypnotic coping skills acquired during an invasive procedure carries over to the next invasive procedure Upon completion the efficacy and durability of procedural administration of nonpharmacologic analgesia will be known by a rigorous and practical assessment The relative performance of self-hypnotic relaxation will be quantified compared to standard care and empathic controls in a well-characterized population of patients within the controlled and monitored environment of a busy interventional radiology practice Results from this competing renewal will provide the next level of data needed for future study design to determine broad clinical utility in a multicenter randomized controlled trial
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None