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
  Purpose

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.


Condition Intervention Phase
Pain
Anxiety
Behavioral: Self-hypnotic relaxation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nonpharmacologic Analgesia for Invasive Procedures

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 390
Study Start Date: September 1997
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00010855

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Investigators
Principal Investigator: Elvira V. Lang, MD Beth Israel Deaconess Medical Center
  More Information

Publications:
Lang EV, Laser E. Hypnosis in Radiology. In: Temes R. Contemporary Medical Hypnosis: A Clinical Guide. Churchill Livingstone 1998, 95-105
Lang EV, Porter DH. Analgesia and sedation for interventional radiological procedures. In: Murphy TP, Benenati JF, Kaufman JA (eds) SCVIR Syllabus. Patient Care in Interventional Radiology. 1999:65-90
Lang EV, Lutgendorf S, Logan H, Benotsch EG, Laser E, Spiegel D. Nonpharmacologic analgesia and anxiolysis for interventional radiological procedures. Seminars in Interventional Radiology 1999; 16: 113-123
Lang EV, Benotsch EG, Fick LJ. Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunct nonpharmacologic analgesia for invasive medical procedures: A randomized trial. Excerpted from article in The Lancet 2000; 355:1486-1490 - and printed in Evidence-Based Mental Health
Lang EV. Use of sedation and pain control in interventional procedures. Syllabus Series of the Society of Cardiovascular and Interventional Radiology, in press, planned print March 2001
Lang EV, Spiegel D, Smith, WL. Nonpharmacologic analgesia in the radiology department. Radiology 1997; 205(P): 33
Benotsch E, Lang EV, Lutgendorf S, Fick LJ. Preoperative anxiety and procedural pain, anxiety, and physiologic functioning. Ann Behav Med 1998; 20(S): 92
Benotsch E, Watson D, Lang EV, Lutgendorf S, Fick LJ. Trait negative affect and psychological preparation for invasive procedures. Ann Behavioral Med 1988; 20(S): 58
Lang EV, Rosen M. Impact of self-hypnotic relaxation on cost of IV conscious sedation during outpatient angiography: a decision analysis model. Radiology 1999; 213 (P): 434

ClinicalTrials.gov Identifier: NCT00010855     History of Changes
Obsolete Identifiers: NCT00008944
Other Study ID Numbers: R01 AT000002
Study First Received: February 2, 2001
Last Updated: August 4, 2008
Health Authority: United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
hypnosis
relaxation
invasive medical procedures
interventional radiology
conscious sedation
anesthesia
complications
cost analysis
Interventional procedures, complications
Angiography
Nephrostomy
Hepatic chemoembolization
Fibroid Embolization

ClinicalTrials.gov processed this record on October 23, 2014