- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01424072
Auriculotherapy as a Coping Strategy in Professional Nursing
April 22, 2013 updated by: Leonice Fumiko Sato Kurebayashi, University of Sao Paulo
Applicability of Auriculotherapy as a Strategy for Stress and Coping in Nursing Professionals
This randomized clinical trial aimed at evaluating the auriculotherapy as coping strategies in 75 nursing professionals in a University Hospital.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There is consensus that psychological and social factors can lead to physical health problems of individuals and coping strategies in stressful situations may be crucial for the mental, physical and social development of people.
Taking care of professionals who provide health services is a key strategy, since good results depend on the service, especially in work teams healthy and, therefore, able to promote the humanization of service.
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
São Paulo, Brazil, 05508-000
- Hospital Universitário de São Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 61 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
Other Names:
|
Experimental: Auriculotherapy by seeds
The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.
|
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.
Other Names:
|
No Intervention: Control Group
Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Coping Strategy: Domain Social Support(After 60 Days)
Time Frame: after 60days
|
Scale information: Folkman and Lazarus Coping Strategy Inventory with 66 items.
The scale is constructed by 8 different "domains": confrontation, distancing, self-control, social support, acceptance of responsibility, escape avoidance, problem solving and positive reappraisal.The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory).
It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty).
|
after 60days
|
Coping Strategy: Distancing Domain
Time Frame: after 75 days
|
The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory).
It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty).
|
after 75 days
|
Coping Strategy: Social Support Domain
Time Frame: after 60 days
|
Scale information: Folkman and Lazarus Coping Strategy Inventory with 66 items.
The scale is constructed by 8 different "domains": confrontation, distancing, self-control, social support, acceptance of responsibility, escape avoidance, problem solving and positive reappraisal.The questions are scored by Likert scale: 0 (not used this strategy); 1 (used somewhat); 2 (used enough) and 3(used in large quantities) to the 66 items (Folkman and Lazarus Coping Strategy Inventory).
It performed a summation of items and defined the scores: 0-4 points (not use this strategy), 5-9 (use this strategy a bit), 10-14 ( use this strategy quite) 14-18 (use strategy plenty).
|
after 60 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stress Scale
Time Frame: after 60 days
|
Scale information: Stress Symptoms List (LSS)with 60 items (better outcome)Low score: 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): >120 points.
|
after 60 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Leonice FS Kurebayashi, University of Sao Paulo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
August 23, 2011
First Submitted That Met QC Criteria
August 24, 2011
First Posted (Estimate)
August 26, 2011
Study Record Updates
Last Update Posted (Estimate)
May 31, 2013
Last Update Submitted That Met QC Criteria
April 22, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE: 0060.0.198.000-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress, Psychological
-
New York State Psychiatric InstituteJohnson & JohnsonCompletedPsychological Stress in PregnancyUnited States
-
Baylor UniversityCompletedAcute Psychological StressUnited States
-
Örebro University, SwedenCompletedPsychological Stress Due to SkydivingSweden
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
Amrita Vishwa VidyapeethamAmrita Viswa VidyapeethamCompletedCovid Related Psychological StressIndia
-
Institut de Recherche Biomedicale des ArmeesCompletedPsychological Stresses
-
University of California, San FranciscoNational Institute on Aging (NIA); Penn State University; Harvard UniversityCompletedStress | Depressive Symptoms | Psychological Distress | Psychological Stress | Signs and Symptoms | Psychological | Child MaltreatmentUnited States
-
Penn State UniversityStony Brook University; National Institute on Aging (NIA); Oregon State University and other collaboratorsCompleted
-
Military Academy at ETH ZurichSwiss Armed ForcesCompletedPsychological Stress | Psychological AdaptationSwitzerland
-
Nagoya City UniversityAichi Health Promotion FoundationCompleted
Clinical Trials on auriculotherapy by needles
-
University of Sao PauloCompleted
-
Columbia UniversityCompleted
-
Hopital FochRecruiting
-
The Hong Kong Polytechnic UniversityCompleted
-
Peking Union Medical CollegeRecruitingArthroplasty, Replacement, Knee | Enhanced Recovery After Surgery | AuriculotherapyChina
-
Universidade do PortoEscola Superior Saúde Santa MariaCompleted
-
Hopital FochCompleted
-
Hopital FochCompleted