Self-Hypnotic Relaxation Therapy During Invasive Procedures
NCT ID: NCT00087841
Last Updated: 2008-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
390 participants
INTERVENTIONAL
2002-04-30
2006-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Self-hypnotic relaxation
Eligibility Criteria
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Inclusion Criteria
* Able to hear and understand English
Exclusion Criteria
* Psychosis
* Severe chronic obstructive pulmonary disease
* Intolerance of midazolam or fentanyl
* Weigh less than 121 lbs
* Pregnancy
18 Years
90 Years
ALL
No
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
Principal Investigators
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Elvira Lang, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Other Identifiers
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