Chinese Auriculotherapy on Stress and Quality of Life in Nursing Professionals: Randomized Clinical Trial

NCT ID: NCT01420835

Last Updated: 2013-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-12-31

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.

Conditions

Stress; Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

without protocol group

Intervention Type: OTHER

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.

Auriculotherapy with protocol

Auriculotherapy with stress protocol points. Five points are indicated for stress (Liver yang1, Liver yang2, Shenmen, Brainstem and Kidney).

Group Type: ACTIVE_COMPARATOR

Auriculotherapy (protocol group)

Intervention Type: OTHER

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.

Control Group

Control Group won't receive any treatment and will be evaluated at the same time and the same way of interventions group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

auricular acupuncture; auricular acupuncture

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sociedade Hospital Samaritano

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Leonice Fumiko Sato Kurebayashi

Leonice Fumiko Sato Kurebayashi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leonice FS Kurebayashi

Role: PRINCIPAL_INVESTIGATOR

Instituto de Terapia Integrada e Oriental

Locations

Samaritan Hospital

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

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.

Reference Type: DERIVED

PMID: 25029046 (View on PubMed)

Other Identifiers

SISNEP CAAE 0050.0.196.196-11

Identifier Type: -

Identifier Source: org_study_id