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Clinical Trials/NCT01420848
NCT01420848CompletedPhase 2

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

University of Sao Paulo2 sites in 1 country71 target enrollmentStarted: January 2011Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
71
Locations
2
Primary Endpoint
Students Stress Levels

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
19 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Students Stress Levels

Time Frame: 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 Outcomes

  • Students Anxiety Levels(90 days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Leonice Fumiko Sato Kurebayashi

Leonice Fumiko Sato Kurebayashi

University of Sao Paulo

Study Sites (2)

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