Auriculotherapy Effectiveness on Stress and Anxiety in Nursing Student

Phase 2

Completed

• Conditions: Stress; Anxiety
• Interventions: Other: Auriculotherapy; Other: Placebo Group

• Registration Number: NCT01420848
• Lead Sponsor: University of Sao Paulo

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2011-08-19
• Study First Submitted QC: 2011-08-19
• Study First Posted: 2011-08-22
• Results First Submitted: 2013-01-30
• Status Verified: 2013-06
• Results First Submitted QC: 2013-06-09
• Last Update Submitted: 2013-06-09
• Results First Posted: 2013-07-15
• Last Update Posted: 2013-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

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Exclusion Criteria

• Pregnancy
• Medical license or vacation during the period
• Low score of stress

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Students Stress Levels	90 days	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

Name	Time	Method
Students Anxiety Levels	90 days	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.

Trial Locations

Locations (1)

Real e Benemérita Associação Portuguesa de Beneficência; 🇧🇷 São Paulo, Brazil