Clinical trial NCT01420835: Chinese Auriculotherapy on Stress and Quality of Life in Nursing Professionals: Randomized Clinical Trial
Official title: Randomized Clinical Trial: Chinese Auriculotherapy With and Without Protocol on Stress and Quality of Life in Nursing Professionals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress
Quality of Life
Keywords: Stress
Quality of life
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Sociedade Hospital Samaritano
First posted: 2011-08-22
Enrollment: 175
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: stress levels
timeFrame: 75 days
Secondary outcomes:
measure: quality of life domains
timeFrame: 75 days
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Samaritan Hospital
Study officials:
affiliation: Instituto de Terapia Integrada e Oriental
name: Leonice FS Kurebayashi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giaponesi ANL, Leão ER. Auriculotherapy as an intervention to reduce stress reduction among the nursing team in intensive care. Nursing (São Paulo);12(139):575-579, dez. 2009. ilus.
citation: Kurebayashi LF, Silva MJ. Efficacy of Chinese auriculotherapy for stress in nursing staff: a randomized clinical trial. Rev Lat Am Enfermagem. 2014 May-Jun;22(3):371-8. doi: 10.1590/0104-1169.3239.2426.