Auriculotherapy Effectiveness on Stress and Anxiety in Nursing Student

The Effectiveness of the Auriculotherapy on Reducing Stress and Anxiety in Nursing Student: Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Stress; Anxiety
• Intervention / Treatment: Other: Auriculotherapy; Other: Placebo 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.

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01323-001
    • Real e Benemerita Associacao Portuguesa de Beneficencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Students Anxiety Levels	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.	90 days

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: Juliana M Prado, University of Sao Paulo; Study Director: Leonice FS Kurebayashi, University of Sao Paulo; Study Chair: Maria Julia P Silva, University of Sao Paulo

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): August 1, 2011

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): July 15, 2013
• Last Update Submitted That Met QC Criteria: June 9, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: anxiety disorders; stress disorders
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: SISNEP CAAE 0107.0.360.000-11