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Nonpharmacologic Analgesia for Invasive Procedures

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00010855
First received: February 2, 2001
Last updated: August 4, 2008
Last verified: August 2008

February 2, 2001
August 4, 2008
September 1997
April 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00010855 on ClinicalTrials.gov Archive Site
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Nonpharmacologic Analgesia for Invasive Procedures
Nonpharmacologic Analgesia for Invasive Procedures

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 47,000 patients will suffer serious cardiorespiratory complications and 2,600 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.

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Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pain
  • Anxiety
Behavioral: Self-hypnotic relaxation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
390
April 2007
April 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients referred for transcatheter embolization for benign uterine fibroid tumors or malignant hepatic tumors.
  • Patients referred for radiofrequency ablation of malignant hepatic or renal tumors

Exclusion Criteria:

  • Unable to give informed consent
  • Impaired mental function, psychosis, severe chronic obstructive pulmonary disease, intolerance towards midazolam or fentanyl
  • Weigh < 55 kg
  • Pregnant
  • Unable to hear or understand English
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010855
R01 AT000002
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Elvira V. Lang, MD Beth Israel Deaconess Medical Center
National Center for Complementary and Alternative Medicine (NCCAM)
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP