Chinese Auriculotherapy on Stress and Quality of Life in Nursing Professionals: Randomized Clinical Trial
|ClinicalTrials.gov Identifier: NCT01420835|
Recruitment Status : Completed
First Posted : August 22, 2011
Last Update Posted : January 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Stress Quality of Life||Other: Auriculotherapy (protocol group) Other: without protocol group||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||175 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Clinical Trial: Chinese Auriculotherapy With and Without Protocol on Stress and Quality of Life in Nursing Professionals|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||December 2012|
Active Comparator: Without Protocol Group
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
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.
Other Name: auricular acupuncture
Active Comparator: Auriculotherapy with protocol
Auriculotherapy with stress protocol points. Five points are indicated for stress (Liver yang1, Liver yang2, Shenmen, Brainstem and Kidney).
Other: Auriculotherapy (protocol 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.
Other Name: auricular acupuncture
No Intervention: Control Group
Control Group won't receive any treatment and will be evaluated at the same time and the same way of interventions group
- stress levels [ Time Frame: 75 days ]The measurement of stress levels will be performed by List of Stress Symptoms (Vasconcellos) and the main symptoms
- quality of life domains [ Time Frame: 75 days ]The assessment of life quality domains will be done by SF36v2
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420835
|São Paulo, Brazil, 01323-001|
|Principal Investigator:||Leonice FS Kurebayashi||Instituto de Terapia Integrada e Oriental|