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Self-hypnotic Relaxation Therapy During Invasive Procedures - Article


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Procedures and Therapies


Clinical Trial: Self-hypnotic Relaxation Therapy During Invasive Procedures

This study is currently recruiting patients.

Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)

Purpose

The purpose of this study is to determine the effectiveness of self-hypnotic relaxation on mental and physical distress during and after tumor treatment procedures.

Condition Treatment or Intervention Phase
Uterine Neoplasms
Leiomyoma
 Behavior: Self-hypnotic relaxation
Phase II

MedlinePlus related topics:  Uterine Cancer;   Uterine Fibroids

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title: Midcareer Development of Nonpharmacologic Analgesia

Further Study Details: 

Expected Total Enrollment:  390

Pain relievers and sedatives may have limited effectiveness and serious side effects when given to alleviate distress during minimally invasive surgical procedures. Unabated distress may interfere with the ongoing procedure and may negatively impact future interventions. Studies have shown that nonpharmacologic analgesia in the form of self-hypnotic relaxation during invasive medical procedures significantly reduces patients' pain, anxiety, drug use, and number of complications. The long-term goal of this study is to determine whether self-hypnotic relaxation therapy can be a safe and practical method for reducing cognitive and physiologic distress associated with invasive procedures.

Participants in this study will be randomly assigned to one of three groups: a standard care group, an empathic control group, and a self-hypnotic relaxation group. The emphatic control group will meet with a clinician who will offer encouragement and support. The group assigned to self-hypnotic relaxation will read a standardized script prior to procedure. Self-report questionnaires will be used to assess pain and anxiety.

Eligibility

Ages Eligible for Study:  18 Years   -   90 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Exclusion Criteria:

  • Impaired mental function
  • Psychosis
  • Severe chronic obstructive pulmonary disease
  • Intolerance of midazolam or fentanyl
  • Weigh less than 121 lbs
  • Pregnancy

Location and Contact Information


Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting
Eva Maria Kettenmann  617-754-2666    ekettenm@bidmc.harvard.edu 
Elvira V. Lang, MD  617-754-2847    elang@bidmc.harvard.edu 
Elvira V. Lang, MD,  Principal Investigator

Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States; Recruiting
Cindy Cobb  401-444-4233    ccobb@lifespan.org 

More Information

Study ID Numbers:  1-K24-AT001074-01
Record last reviewed:  February 2005
Last Updated:  February 10, 2005
Record first received:  July 14, 2004
ClinicalTrials.gov Identifier:  NCT00087841
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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Page Updated: December 17, 2004
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