|
Nonpharmacologic Analgesia for Invasive Procedures Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Nonpharmacologic Analgesia for Invasive Procedures conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Nonpharmacologic Analgesia for Invasive Procedures Clinical research trials and Nonpharmacologic Analgesia for Invasive Procedures health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Nonpharmacologic Analgesia for Invasive Procedures. Nonpharmacologic Analgesia for Invasive Procedures Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Nonpharmacologic Analgesia for Invasive Procedures clinical trial. Human subjects often get the best healthcare possible for their Nonpharmacologic Analgesia for Invasive Procedures condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "N" Clinical Trials Conditions > Nonpharmacologic Analgesia for Invasive Procedures  Nonpharmacologic Analgesia for Invasive Procedures
Nonpharmacologic Analgesia for Invasive Procedures
For Condition: Anxiety,Pain
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) , National Institute of Mental Health (NIMH)
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 18 Years/90 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 390
Location and Contact Information:
Overall Study Official:
ElviraLang, Principal Investigator, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Elvira Lang 617-754-2523
Additional Information:
Study ID Numbers: 5 R01 AT00002-07;
Study Start Date: September 1997
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010855
Other Pain Studies:
1. Nonpharmacologic Analgesia for Invasive Procedures
Related Studies:
Other Pain Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Nonpharmacologic Analgesia for Invasive Procedures
|
|
|
|
|
|
|
|
