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

January 17, 2013 updated by: Leonice Fumiko Sato Kurebayashi, University of Sao Paulo

Randomized Clinical Trial: Chinese Auriculotherapy With and Without Protocol on Stress and Quality of Life in Nursing Professionals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

175

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 01323-001
        • Samaritan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stress levels
Time Frame: 75 days
The measurement of stress levels will be performed by List of Stress Symptoms (Vasconcellos) and the main symptoms
75 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality of life domains
Time Frame: 75 days
The assessment of life quality domains will be done by SF36v2
75 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

Sociedade Hospital Samaritano

Investigators

  • Principal Investigator: Leonice FS Kurebayashi, Instituto de Terapia Integrada e Oriental

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 19, 2011

First Submitted That Met QC Criteria

August 19, 2011

First Posted (Estimate)

August 22, 2011

Study Record Updates

Last Update Posted (Estimate)

January 21, 2013

Last Update Submitted That Met QC Criteria

January 17, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SISNEP CAAE 0050.0.196.196-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Quality of Life

Clinical Trials on without protocol group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe