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Auriculotherapy Effectiveness on Stress and Anxiety in Nursing Student

Primary Purpose

Stress, Anxiety

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Auriculotherapy
Placebo Group
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring stress disorders, anxiety disorders

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Real e Benemérita Associação Portuguesa de Beneficência

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Auriculotherapy Group

Placebo Group

Control Group

Arm Description

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).

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 19, 2011
Last Updated
June 9, 2013
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01420848
Brief Title
Auriculotherapy Effectiveness on Stress and Anxiety in Nursing Student
Official Title
The Effectiveness of the Auriculotherapy on Reducing Stress and Anxiety in Nursing Student: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Anxiety
Keywords
stress disorders, anxiety disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auriculotherapy Group
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
Intervention Type
Other
Intervention Name(s)
Auriculotherapy
Other Intervention Name(s)
Auricular acupuncture
Intervention Description
Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological.
Intervention Type
Other
Intervention Name(s)
Placebo Group
Other Intervention Name(s)
Sham Group
Intervention Description
They were evaluated at the baseline,twelve sessions and 15-day follow-up and received 12 sessions through the Fist and Outer ear points.
Primary Outcome Measure Information:
Title
Students Stress Levels
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Students Anxiety Levels
Description
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.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana M Prado
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leonice FS Kurebayashi
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Maria Julia P Silva
Organizational Affiliation
University of São Paulo
Official's Role
Study Chair
Facility Information:
Facility Name
Real e Benemérita Associação Portuguesa de Beneficência
City
São Paulo
ZIP/Postal Code
01323-001
Country
Brazil

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
result
PubMed Identifier
22990158
Citation
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.
Results Reference
derived

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Auriculotherapy Effectiveness on Stress and Anxiety in Nursing Student

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