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| Sponsor: | National Center for Complementary and Alternative Medicine (NCCAM) |
|---|---|
| Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
| ClinicalTrials.gov Identifier: | NCT00087841 |
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 | Intervention | Phase |
|---|---|---|
|
Uterine Neoplasms Leiomyoma |
Behavioral: Self-hypnotic relaxation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Midcareer Development of Nonpharmacologic Analgesia |
| Estimated Enrollment: | 390 |
| Study Start Date: | April 2002 |
| Study Completion Date: | November 2006 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
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 to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: | Elvira Lang, MD | Beth Israel Deaconess Medical Center |
More Information
| Study ID Numbers: | K24 AT001074-01 |
| Study First Received: | July 14, 2004 |
| Last Updated: | January 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00087841 History of Changes |
| Health Authority: | United States: Federal Government |
|
Hypnosis Analgesia Embolization, Therapeutic Chemoembolization, Therapeutic |
|
Neoplasms, Muscle Tissue Neoplasms by Histologic Type Physiological Effects of Drugs Genital Neoplasms, Female Uterine Diseases Central Nervous System Depressants Urogenital Neoplasms Leiomyoma Pharmacologic Actions |
Genital Diseases, Female Neoplasms, Connective and Soft Tissue Neoplasms Neoplasms by Site Therapeutic Uses Hypnotics and Sedatives Uterine Neoplasms Central Nervous System Agents |
