Auriculotherapy Effectiveness on Stress and Anxiety in Nursing Student

NCT ID: NCT01420848

Last Updated: 2013-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-08-31

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.

Conditions

Stress; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Auriculotherapy

Intervention Type: OTHER

Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological.

Placebo Group

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

Group Type: PLACEBO_COMPARATOR

Placebo Group

Intervention Type: OTHER

They were evaluated at the baseline,twelve sessions and 15-day follow-up and received 12 sessions through the Fist and Outer ear points.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Auriculotherapy

Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

Auricular acupuncture; Sham Group

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Leonice Fumiko Sato Kurebayashi

Leonice Fumiko Sato Kurebayashi

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juliana M Prado

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Leonice FS Kurebayashi

Role: STUDY_DIRECTOR

University of Sao Paulo

Maria Julia P Silva

Role: STUDY_CHAIR

University of Sao Paulo

Locations

Real e Benemérita Associação Portuguesa de Beneficência

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: RESULT

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.

Reference Type: DERIVED

PMID: 22990158 (View on PubMed)

Other Identifiers

SISNEP CAAE 0107.0.360.000-11

Identifier Type: -

Identifier Source: org_study_id