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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 23, 2011

Last Updated Date

April 22, 2013

Start Date ^ICMJE

January 2010

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Coping Strategy: Domain Social Support(After 60 Days) [ Time Frame: after 60days ] [ Designated as safety issue: Yes ]
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).
Coping Strategy: Distancing Domain [ Time Frame: after 75 days ] [ Designated as safety issue: Yes ]
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).
Coping Strategy: Social Support Domain [ Time Frame: after 60 days ] [ Designated as safety issue: Yes ]
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).

Original Primary Outcome Measures ^ICMJE

stress [ Time Frame: 75 days ] [ Designated as safety issue: Yes ]

The stress was evaluated in three phases: baseline, after 4 sessions (one month), 8 sessions (2 months) and follow-up of 15 days.

Change History

Complete list of historical versions of study NCT01424072 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Stress Scale [ Time Frame: after 60 days ] [ Designated as safety issue: Yes ]

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.

Original Secondary Outcome Measures ^ICMJE

coping [ Time Frame: 75 days ] [ Designated as safety issue: Yes ]

Identify the different domains of coping strategies according to the Folkman and Lazarus Inventory in Nursing staff of a University Hospital. These domains were evaluated in three phases: baseline, after 4 sessions (one month), 8 sessions (2 months) and follow-up of 15 days.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Auriculotherapy as a Coping Strategy in Professional Nursing

Official Title ^ICMJE

Applicability of Auriculotherapy as a Strategy for Stress and Coping in Nursing Professionals

Brief Summary

This randomized clinical trial aimed at evaluating the auriculotherapy as coping strategies in 75 nursing professionals in a University Hospital.

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 ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Stress, Psychological
Coping Behavior

Intervention ^ICMJE

Other: 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.

Other Name: auricular acupuncture
Other: 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.

Other Name: auricular acupuncture by seeds

Study Arm (s)

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
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.

Intervention: Other: auriculotherapy by needles
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.

Intervention: Other: auriculotherapy by seeds

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

23 Years to 61 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01424072

Other Study ID Numbers ^ICMJE

CAAE: 0060.0.198.000-09

Has Data Monitoring Committee

Responsible Party

Leonice Fumiko Sato Kurebayashi, University of Sao Paulo

Study Sponsor ^ICMJE

University of Sao Paulo

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Leonice FS Kurebayashi

University of São Paulo

Information Provided By

University of Sao Paulo

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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