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

This study has been completed.
Sponsor:
Collaborator:
Sociedade Hospital Samaritano
Information provided by (Responsible Party):
Leonice Fumiko Sato Kurebayashi, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01420835
First received: August 19, 2011
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Stress
Quality of Life
Other: Auriculotherapy (protocol group)
Other: without protocol group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial: Chinese Auriculotherapy With and Without Protocol on Stress and Quality of Life in Nursing Professionals

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • stress levels [ Time Frame: 75 days ] [ Designated as safety issue: No ]
    The measurement of stress levels will be performed by List of Stress Symptoms (Vasconcellos) and the main symptoms


Secondary Outcome Measures:
  • quality of life domains [ Time Frame: 75 days ] [ Designated as safety issue: No ]
    The assessment of life quality domains will be done by SF36v2


Enrollment: 175
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420835

Locations
Brazil
Samaritan Hospital
São Paulo, Brazil, 01323-001
Sponsors and Collaborators
University of Sao Paulo
Sociedade Hospital Samaritano
Investigators
Principal Investigator: Leonice FS Kurebayashi Instituto de Terapia Integrada e Oriental
  More Information

Additional Information:
No publications provided

Responsible Party: Leonice Fumiko Sato Kurebayashi, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01420835     History of Changes
Other Study ID Numbers: SISNEP CAAE 0050.0.196.196-11
Study First Received: August 19, 2011
Last Updated: January 17, 2013
Health Authority: Brazil: Ethics Committee
United States: Food and Drug Administration

Keywords provided by University of Sao Paulo:
Stress
Quality of life

ClinicalTrials.gov processed this record on August 20, 2014