Application of Auriculotherapy on Nursing Professional Stress Levels

NCT01141374 | Completed Phase 2 Results

• 1 other identifier: SISNEP
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Randomized controlled trial aimed to assess stress levels in nursing staff and review the auriculotherapy effectiveness through semi-permanent needles and seeds.

Conditions

Stress

Keywords

Stress

Outcome Measures

Primary Outcomes (1)

• Stress Levels After 4 Sessions (2nd Evaluation)

  Scale information: Stress Symptoms List (LSS)with 60 items (better outcome)Low score: 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): \>120 points.

  after 30 days

Secondary Outcomes (1)

• Stress Levels(3rd and 4th Evaluation)

  after 60 and 75 days

Study Arms (3)

control group without treatment

NO INTERVENTION

Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group

Auriculotherapy by needles

EXPERIMENTAL

The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.

Other: auriculotherapy by needles

Auriculotherapy by seeds

EXPERIMENTAL

The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.

Other: auriculotherapy by seeds

Interventions

auriculotherapy by needles 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.

Also known as: auricular acupuncture

Auriculotherapy by needles

auriculotherapy by seeds OTHER

We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.

Also known as: Auricular acupuncture by seeds

Auriculotherapy by seeds

Eligibility Criteria

• Age: 23 Years - 61 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Average and high score by the List of Stress Symptoms
• 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
• Low score of stress

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital Universitário da Universidade de São Paulo

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Interventions

Acupuncture, Ear

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Limitations and Caveats

Study limitations: small sample size Bias procedure with auricular seeds: the non-participation of the subject of research in self-massage of the points

Results Point of Contact

• Title: Leonice Fumiko Sato Kurebayashi
• Organization: University of São Paulo

fumie_ibez@yahoo.com.br

55-11-91126023

Study Officials

• Maria Julia P Silva

  Escola de Enfermagem da Universidade de São Paulo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: June 4, 2010
• First Posted: June 10, 2010
• Study Start: January 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 24, 2013
• Results First Posted: January 23, 2012

Record last verified: 2013-01

Locations

BR (1)