NCT01420848

Brief Summary

Single-blind randomized controlled trial aimed to assess stress and anxiety levels in Nursing School students of Beneficence Portuguese Hospital and review the effectiveness of true and placebo auriculotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 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

Study Start

First participant enrolled

January 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
18 days until next milestone

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
1.9 years until next milestone

Results Posted

Study results publicly available

July 15, 2013

Completed
Last Updated

July 15, 2013

Status Verified

June 1, 2013

Enrollment Period

7 months

First QC Date

August 19, 2011

Results QC Date

January 30, 2013

Last Update Submit

June 9, 2013

Conditions

StressAnxiety

Keywords

stress disordersanxiety disorders

Outcome Measures

Primary Outcomes (1)

  • Students Stress Levels

    The List of Symptoms of Stress is an evaluation questionnaire which consists of a list of 59 psycho-physiological and psychosocial stress, in which the subject must associate to each symptom of the four answers: never (0), rarely (1 ), often (2) or always (3). The scores are added together and the answers provide the level of stress the individual.In this questionnaire to score from 0 to 11 is void, 12 to 29 (low level), 30 to 59 (medium level), 60 to 120 (high level) and 120 to 177, very high level. Participants below 29 points were excluded.

    90 days

Secondary Outcomes (1)

  • Students Anxiety Levels

    90 days

Study Arms (3)

Auriculotherapy 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. Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).

Other: Auriculotherapy

Placebo Group

PLACEBO COMPARATOR

Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.

Other: Placebo Group

Control Group

NO INTERVENTION

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

Interventions

AuriculotherapyOTHER

Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological.

Also known as: Auricular acupuncture
Auriculotherapy Group
Placebo GroupOTHER

They were evaluated at the baseline,twelve sessions and 15-day follow-up and received 12 sessions through the Fist and Outer ear points.

Also known as: Sham Group
Placebo Group

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Real e Benemérita Associação Portuguesa de Beneficência

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

  • do Prado JM, Kurebayashi LF, da Silva MJ. Efficacy of auriculotherapy for the reduction of stress in nursing students: a randomized clinical trial. Rev Lat Am Enfermagem. 2012 Jul-Aug;20(4):727-35. doi: 10.1590/s0104-11692012000400013. English, Portuguese, Spanish.

    PMID: 22990158DERIVED

MeSH Terms

Conditions

Anxiety DisordersStress Disorders, Traumatic

Interventions

AuriculotherapyAcupuncture, Ear

Condition Hierarchy (Ancestors)

Mental DisordersTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsAcupuncture Therapy

Limitations and Caveats

The limitation of the trial was the reduced number of the sample.

Results Point of Contact

Title
Leonice Fumiko Sato Kurebayashi
Organization
University of São Paulo
fumie_ibez@yahoo.com.br
(5511 991126023)

Study Officials

  • Juliana M Prado

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Leonice FS Kurebayashi

    University of Sao Paulo

    STUDY DIRECTOR

  • Maria Julia P Silva

    University of Sao Paulo

    STUDY CHAIR

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

August 19, 2011

First Posted

August 22, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

July 15, 2013

Results First Posted

July 15, 2013

Record last verified: 2013-06

Locations

BR(1)