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

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01420835
Collaborator
Sociedade Hospital Samaritano (Other)
175
1
3
15
11.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Auriculotherapy (protocol group)
  • Other: without protocol group
Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
175 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Randomized Clinical Trial: Chinese Auriculotherapy With and Without Protocol on Stress and Quality of Life in Nursing Professionals
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

    1. stress levels [75 days]

      The measurement of stress levels will be performed by List of Stress Symptoms (Vasconcellos) and the main symptoms

    Secondary Outcome Measures

    1. quality of life domains [75 days]

      The assessment of life quality domains will be done by SF36v2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Leonice Fumiko Sato Kurebayashi, Leonice Fumiko Sato Kurebayashi, University of Sao Paulo
    ClinicalTrials.gov Identifier:
    NCT01420835
    Other Study ID Numbers:
    • SISNEP CAAE 0050.0.196.196-11
    First Posted:
    Aug 22, 2011
    Last Update Posted:
    Jan 21, 2013
    Last Verified:
    Jan 1, 2013
    Keywords provided by Leonice Fumiko Sato Kurebayashi, Leonice Fumiko Sato Kurebayashi, University of Sao Paulo

    Study Results

    No Results Posted as of Jan 21, 2013