Nonpharmacologic Analgesia for Invasive Procedures
Condition: Pain; Anxiety
Study type: Interventional
Phase: Phase 2/Phase 3

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 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.
    


Intervention name(s): Self-hypnotic relaxation
Intervention type(s): Behavioral
Intervention MeSH terms: Hypnotics and Sedatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypnosis; relaxation; invasive medical procedures; interventional radiology; conscious sedation; anesthesia; complications; cost analysis; Interventional procedures, complications; Angiography; Nephrostomy; Hepatic chemoembolization; Fibroid Embolization