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| Descriptive Information Fields | |||||
| Brief Title † | Shamanic Healing for Women With Temporomandibular Joint Disorders (TMDs) | ||||
| Official Title † | |||||
| Brief Summary | This is a Phase I study to examine the feasibility and safety of shamanic (spiritual) healing for treating temporomandibular joint disorders (TMDs). |
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| Detailed Description | Traditional systems of healing, such as shamanism, do not readily lend themselves to conventional research methods, yet studying their effectiveness is especially germane in the case of chronic conditions that involve an emotional component and that elude allopathic treatment regimens. Temporomandibular joint disorders (TMDs), which affect up to 10% of the adult population, are a prime example of such conditions. Traditional treatment outcomes for TMD pain are often unsatisfactory. Moreover, in women age 25-55 (the age-sex group most affected), TMD is often found in association with depression, anxiety, sleep disturbances, gastrointestinal symptoms, frequent infection,and fibromyalgia. Because these multiple and complex symptoms suggest a loss of spirit or life energy, they may be particularly susceptible to treatment by shamanic (spiritual) healing, which aims to bring disturbed physical, mental, and emotional systems into balance. This phase I study will develop methods to evaluate shamanic healing as an intervention for TMD and will evaluate the feasibility of conducting randomized clinical trials of shamanic healing. |
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| Study Phase | Phase I | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Temporomandibular Disorders | ||||
| Intervention † | Procedure: shamanic healing | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 25 | ||||
| Start Date † | August 2003 | ||||
| Completion Date | May 2005 | ||||
| Eligibility Criteria † | Inclusion criteria:
Exclusion criteria:
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| Gender | Female | ||||
| Ages | 25 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00071474 | ||||
| Organization ID | R21 AT000951-01A2 | ||||
| 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 2007 | ||||
| First Received Date † | October 23, 2003 | ||||
| Last Updated Date | January 22, 2007 | ||||