Auriculotherapy Effectiveness on Stress and Anxiety in Nursing Student

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leonice Fumiko Sato Kurebayashi, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01420848
First received: August 19, 2011
Last updated: June 9, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Stress
Anxiety
Other: Auriculotherapy
Other: Placebo Group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Effectiveness of the Auriculotherapy on Reducing Stress and Anxiety in Nursing Student: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Students Stress Levels [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Students Anxiety Levels [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    The State-Trait Anxiety Inventory consists of 2 scales, each one containing 20 items. One of the scales evaluates state anxiety, characterized by subjective feelings of tension and apprehension, followed by autonomic nervous system responses at a given moment. Trait anxiety, assessed by the other scale, refers to a relatively stable tendency to perceive situations at threatening and react anxiously to them. The scores are divided into low, moderate, high and very high and are determined by the sum of 20 symptoms from a 5-point Likert-type scale.The range of scores is 20-80, the higher the score indicating greater anxiety for both the Trait and State Anxiety.


Enrollment: 71
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Auriculotherapy 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.

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

Other: Auriculotherapy
Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological.
Other Name: Auricular acupuncture
Placebo Comparator: Placebo Group
Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
Other: Placebo Group
They were evaluated at the baseline,twelve sessions and 15-day follow-up and received 12 sessions through the Fist and Outer ear points.
Other Name: Sham Group
No Intervention: Control Group
Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group

Detailed Description:

Although researches on stress have a strong focus on stress at work,it is very important the evaluation of the stress and its consequences in Nursing students. This allows to understand which stress factors experienced in a negative way could interfere on the adaptive success in school activities. Students can experience symptoms of the alarm phase of stress such as tachycardia, muscle tension, skin and cold extremities, and also the second phase of stress such as headache, sleepiness, irritability and difficulty concentrating. High levels of stress have a substantial effect on attention and can lead to errors, lack of concentration and fluctuations in the level of attention. The auriculotherapy may have an important role as a coping strategy for stress and anxiety. It is a fast, relatively simple, easily performed, safe and without major side effects.

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Average and high score by the List of Stress Symptoms
  • Voluntary participation in the study
  • Availability of time for submission to the sessions

Exclusion Criteria:

  • Pregnancy
  • Medical license or vacation during the period
  • Low score of stress
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420848

Locations
Brazil
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, Brazil, 01323-001
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Juliana M Prado university of são paulo
Study Director: Leonice FS Kurebayashi university of são paulo
Study Chair: Maria Julia P Silva university of são paulo
  More Information

Additional Information:
No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Leonice Fumiko Sato Kurebayashi, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01420848     History of Changes
Other Study ID Numbers: SISNEP CAAE 0107.0.360.000-11
Study First Received: August 19, 2011
Results First Received: January 30, 2013
Last Updated: June 9, 2013
Health Authority: United States: Food and Drug Administration
Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
stress disorders
anxiety disorders

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014