A Phase 2 interventional study of Auriculotherapy (protocol group) and without protocol group in Stress and Quality of Life, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2013-01-21.
Sponsored by University of Sao Paulo · Phase 2, Interventional, and Treatment
The purpose of this study is to assess stress levels and quality of life in the nursing team of Samaritan Hospital and evaluate the effectiveness of Chinese auriculotherapy used with and without closed protocol on reducing the stress levels and improvement of life quality.
Based on the positive results achieved in a preliminary study conducted in January and February 2010, entitled "Applicability of auricular needles or seeds for the reduction of stress in nursing professionals" at the University Hospital, emerged from this research project in order to extend the first study, with a more representative sample and with a design that would allow further discussions on the effectiveness of Chinese auricular needles semi-permanent to reduce stress and thereby improving the quality of life of nursing professionals. This clinical trial aims, above all, compare the results of the technique with the use of closed protocol and a group without protocol. The latter, however, shall be based on energy evaluation according to Traditional Chinese Medicine (TCM) and the course of treatment will be performed similarly to the clinical practice commonly performed by traditional practitioners, that is, individually, not necessarily repetitive and whose continuation is achieved depending on the answers to each treatment.
Discussions are justified about protocol and no protocol research in complementary and integrative practices, since the methodologies proposed and accepted by the scientific community does not always seem to be appropriate tools for evaluating therapies like those coming from the East. The transfer of the Western conception of research according to positivist principles are not always consistent with the principles underlying the complementary and alternative therapies, and in particular the practice from China.
University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Score by the List of Stress Symptoms (40 to 95 points)
Voluntary participation in the study
Availability of time for submission to the sessions
Exclusion Criteria:
Pregnancy
Medical license or vacation during the period
If they perform another chinese treatment like a massage, acupuncture, moxibustion etc
The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion. Five points will be chosen to treat stress according to the symptoms and Chinese diagnosis.
Other: without protocol group
Auriculotherapy with stress protocol points. Five points are indicated for stress (Liver yang1, Liver yang2, Shenmen, Brainstem and Kidney).
Other: Auriculotherapy (protocol group)
Control Group won't receive any treatment and will be evaluated at the same time and the same way of interventions group
The auriculotherapy points of the protocol group will be 5 points (Liver yang1, Liver yang2, Shenmen, Kidney, Brainstem), during 45 days, twice per week, 12 sessions and assessment of the follow-up (30 days) after finishing the treatment.
Also known as: auricular acupuncture
The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion. Five points will be chosen to treat stress according to the symptoms and the Chinese diagnosis.
Also known as: auricular acupuncture
stress levels
The measurement of stress levels will be performed by List of Stress Symptoms (Vasconcellos) and the main symptoms
Time frame: 75 days
quality of life domains
The assessment of life quality domains will be done by SF36v2
Time frame: 75 days
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo