Auriculotherapy as a Coping Strategy in Professional Nursing

NCT01424072 | Completed Phase 1 Results

• 1 other identifier: CAAE: 0060.0.198.000-09
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stress, Psychological; Coping Behavior

Keywords

stress psychological; coping behavior

Outcome Measures

Primary Outcomes (3)

• Coping Strategy: Domain Social Support(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 60days

• Coping Strategy: Distancing Domain

  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

  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 Outcomes (1)

• Stress Scale

  after 60 days

Study Arms (3)

Control Group

NO INTERVENTION

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

Auriculotherapy by needles

EXPERIMENTAL

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.

Other: auriculotherapy by needles

Auriculotherapy by seeds

EXPERIMENTAL

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

Other: auriculotherapy by seeds

Interventions

auriculotherapy by needles OTHER

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.

Also known as: auricular acupuncture

Auriculotherapy by needles

auriculotherapy by seeds OTHER

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.

Also known as: auricular acupuncture by seeds

Auriculotherapy by seeds

Eligibility Criteria

• Age: 23 Years - 61 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Average and high score by the List of Stress Symptoms
• Voluntary participation in the study
• Availability of time for submission to the sessions

You may not qualify if:

• Pregnancy
• Medical license or vacation during the period
• Low score of stress

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Hospital Universitário de São Paulo

São Paulo, São Paulo, 05508-000, Brazil

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Limitations and Caveats

Number of the participants(reduced sample)

Results Point of Contact

• Title: Leonice Fumiko Sato Kurebayashi
• Organization: University of São Paulo

fumie_ibez@yahoo.com.br

5511 991126023

Study Officials

• Leonice FS Kurebayashi

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leonice Fumiko Sato Kurebayashi

Study Record Dates

• First Submitted: August 23, 2011
• First Posted: August 26, 2011
• Study Start: January 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2011
• Last Updated: May 31, 2013
• Results First Posted: May 31, 2013

Record last verified: 2013-04

Locations

BR (1)