NCT01420835

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
175

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 21, 2013

Status Verified

January 1, 2013

Enrollment Period

2 months

First QC Date

August 19, 2011

Last Update Submit

January 17, 2013

Conditions

StressQuality of Life

Keywords

StressQuality of life

Outcome Measures

Primary Outcomes (1)

  • stress levels

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

    75 days

Secondary Outcomes (1)

  • quality of life domains

    75 days

Study Arms (3)

Without Protocol Group

ACTIVE COMPARATOR

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

Auriculotherapy with protocol

ACTIVE COMPARATOR

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

Other: Auriculotherapy (protocol group)

Control Group

NO INTERVENTION

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

Interventions

Auriculotherapy (protocol group)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.

Also known as: auricular acupuncture
Auriculotherapy with protocol
without protocol groupOTHER

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.

Also known as: auricular acupuncture
Without Protocol Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Score by the List of Stress Symptoms (40 to 95 points)
  • Voluntary participation in the study
  • Availability of time for submission to the sessions

You may not qualify if:

  • Pregnancy
  • Medical license or vacation during the period
  • If they perform another chinese treatment like a massage, acupuncture, moxibustion etc

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samaritan Hospital

São Paulo, São Paulo, 01323-001, Brazil

Location

Related Publications (2)

  • 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.

    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.

    PMID: 25029046DERIVED

MeSH Terms

Interventions

AuriculotherapyAcupuncture, Ear

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsAcupuncture Therapy

Study Officials

  • Leonice FS Kurebayashi

    Instituto de Terapia Integrada e Oriental

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Leonice Fumiko Sato Kurebayashi

Study Record Dates

First Submitted

August 19, 2011

First Posted

August 22, 2011

Study Start

September 1, 2011

Primary Completion

November 1, 2011

Study Completion

December 1, 2012

Last Updated

January 21, 2013

Record last verified: 2013-01

Locations

BR(1)