Auriculotherapy as a Coping Strategy in Professional Nursing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Leonice Fumiko Sato Kurebayashi, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01424072
First received: August 23, 2011
Last updated: April 22, 2013
Last verified: April 2013
Results First Received: January 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Stress, Psychological
Coping Behavior
Interventions: Other: auriculotherapy by needles
Other: auriculotherapy by seeds

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was conducted between January and September 2011 at University Hospital. Study participants were professionals from different sectors of the hospital after the invitation and 109 people answered the Stress Symptoms List. Obeying the exclusion criteria, 75 subjects were enrolled and randomized into three groups.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 109 subjects, 4 were eliminated for having a low level of stress and three for not belonging to nursing staff.

Reporting Groups
  Description
Auriculotherapy by Needles

The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.

auriculotherapy by needles : 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.

Auriculotherapy by Seeds

The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.

auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.

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

Participant Flow:   Overall Study
    Auriculotherapy by Needles     Auriculotherapy by Seeds     Control Group  
STARTED     27     26     22  
COMPLETED     27     26     22  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Auriculotherapy by Needles

The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.

auriculotherapy by needles : 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.

Auriculotherapy by Seeds

The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.

auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.

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

Baseline Measures
    Auriculotherapy by Needles     Auriculotherapy by Seeds     Control Group     Total  
Number of Participants  
[units: participants]
  27     26     22     75  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     27     26     22     75  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  41.37  ± 8.23     45.57  ± 6.40     39.25  ± 13.17     42.06  ± 9.27  
Gender  
[units: participants]
       
Female     25     25     21     71  
Male     2     1     1     4  
Region of Enrollment  
[units: participants]
       
Brazil     27     26     22     75  



  Outcome Measures
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1.  Primary:   Coping Strategy: Domain Social Support(After 60 Days)   [ Time Frame: after 60days ]

2.  Primary:   Coping Strategy: Distancing Domain   [ Time Frame: after 75 days ]

3.  Primary:   Coping Strategy: Social Support Domain   [ Time Frame: after 60 days ]

4.  Secondary:   Stress Scale   [ Time Frame: after 60 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Number of the participants(reduced sample)


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Leonice Fumiko Sato Kurebayashi
Organization: University of São Paulo
phone: 5511 991126023
e-mail: fumie_ibez@yahoo.com.br


No publications provided


Responsible Party: Leonice Fumiko Sato Kurebayashi, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01424072     History of Changes
Other Study ID Numbers: CAAE: 0060.0.198.000-09
Study First Received: August 23, 2011
Results First Received: January 28, 2013
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration
Brazil: National Committee of Ethics in Research