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. Distress management for these procedures, in general, relies on """"""""intravenous conscious sedation"""""""" with narcotics and sedatives. Extrapolating the risk of intravenous conscious sedation to the number of procedures, we predict annually 47,000 patients to suffer serious cardiorespiratory complications and 2,600 deaths. We propose nonpharmacologic analgesia for safe management of cognitive and physiologic distress during and after procedures. Nonpharmacologic analgesia includes relaxation training, self-hypnosis, and imagery. With the current funding, we were able to show that self-hypnotic relaxation offered to patients during vascular and renal interventions significantly reduced physiologic and cognitive distress. As the differences between hypnosis and control treatments grew linearly over the procedure time, questions arose as to whether these effects extend similarly into the recovery period and beyond; and whether patients with lengthier and more painful procedures, such as tumor embolizations, would benefit.
The specific aims are: 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 cognitive and physiologic distress in the postoperative period, and 3) Determine the impact of intraprocedural self- hypnotic relaxation on distress during subsequent tumor embolization. We hypothesize that self-hypnotic relaxation decreases cognitive and physiologic distress (1) during tumor embolizations, (2) after tumor embolization when post- embolization ischemia sets, and (3) when patients return for repeat tumor embolizations. On completion, the efficacy and durability administration of nonpharmacologic analgesia will be known by a rigorous and practical assessment of 390 patients. The relative performance of self-hypnotic relaxation will be quantified compared to standard care and empathic controls in a well- characterized population of patients. Results will provide the next level of data needed for future study design to determine broad clinical utility in a multicenter randomized controlled trial.

Agency
National Institute of Health (NIH)
Institute
National Center for Complementary & Alternative Medicine (NCCAM)
Type
Research Project (R01)
Project #
5R01AT000002-06
Application #
6512068
Study Section
Special Emphasis Panel (ZRG1-RPHB-3 (01))
Program Officer
Stoney, Catherine
Project Start
1997-09-30
Project End
2006-04-29
Budget Start
2002-05-01
Budget End
2003-04-30
Support Year
6
Fiscal Year
2002
Total Cost
$340,000
Indirect Cost
Name
Beth Israel Deaconess Medical Center
Department
Type
DUNS #
076593722
City
Boston
State
MA
Country
United States
Zip Code
02215
Kadom, Nadja; Nguyen, Xuan V; Jensen, Mark P et al. (2017) Effects of Patients' Affect on Adverse Procedural Events during Image-Guided Interventions. J Vasc Interv Radiol 28:1732-1738
Lang, Elvira V; Tan, Gabriel; Amihai, Ido et al. (2014) Analyzing acute procedural pain in clinical trials. Pain 155:1365-73
Flory, Nicole; Lang, Elvira V (2011) Distress in the radiology waiting room. Radiology 260:166-73
Flory, Nicole; Lang, Elvira (2008) Practical hypnotic interventions during invasive cancer diagnosis and treatment. Hematol Oncol Clin North Am 22:709-25, ix
Lang, Elvira V; Berbaum, Kevin S; Pauker, Stephen G et al. (2008) Beneficial effects of hypnosis and adverse effects of empathic attention during percutaneous tumor treatment: when being nice does not suffice. J Vasc Interv Radiol 19:897-905
Lutgendorf, Susan K; Lang, Elvira V; Berbaum, Kevin S et al. (2007) Effects of age on responsiveness to adjunct hypnotic analgesia during invasive medical procedures. Psychosom Med 69:191-9
Flory, Nicole; Salazar, Gloria M Martinez; Lang, Elvira V (2007) Hypnosis for acute distress management during medical procedures. Int J Clin Exp Hypn 55:303-17
Lang, Elvira V; Berbaum, Kevin S; Faintuch, Salomao et al. (2006) Adjunctive self-hypnotic relaxation for outpatient medical procedures: a prospective randomized trial with women undergoing large core breast biopsy. Pain 126:155-64
Schupp, Christine J; Berbaum, Kevin; Berbaum, Michael et al. (2005) Pain and anxiety during interventional radiologic procedures: effect of patients' state anxiety at baseline and modulation by nonpharmacologic analgesia adjuncts. J Vasc Interv Radiol 16:1585-92
Lang, Elvira V; Sood, Ajay; Anderson, Brad et al. (2005) Interpersonal and communication skills training for radiology trainees using a rotating peer supervision model (microteaching). Acad Radiol 12:901-8

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