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| Descriptive Information Fields | |||||
| Brief Title † | Self-Hypnotic Relaxation Therapy During Invasive Procedures | ||||
| Official Title † | Midcareer Development of Nonpharmacologic Analgesia | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Uterine Neoplasms Leiomyoma |
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| Intervention † | Behavioral: Self-hypnotic relaxation | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 390 | ||||
| Start Date † | April 2002 | ||||
| Completion Date | November 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00087841 | ||||
| Organization ID | K24 AT001074-01 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | January 2008 | ||||
| First Received Date † | July 14, 2004 | ||||
| Last Updated Date | January 15, 2008 | ||||