Stress, PsychologicalPhase 1/2NCT01424072
Auriculotherapy as a Coping Strategy in Professional Nursing
A Phase 1/2 study testing auriculotherapy by needles and auriculotherapy by seeds in people with Stress, Psychological and Coping Behavior, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This randomized clinical trial aimed at evaluating the auriculotherapy as coping strategies in 75 nursing professionals in a University Hospital. Read more about this study
- Who is it for?
- Ages 23 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Coping Behavior
- What is being tested?
- auriculotherapy by needles and auriculotherapy by seeds
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Sep 2011
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 61 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Average and high score by the List of Stress Symptoms
- Voluntary participation in the study
- Availability of time for submission to the sessions
Who cannot join
- Pregnancy
- Medical license or vacation during the period
- Low score of stress
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário de São Paulo
São Paulo, São Paulo, 05508-000
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Psychological, Coping Behavior
- Being tested
- auriculotherapy by needles, auriculotherapy by seeds
- Keywords
- stress psychological, coping behavior
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auriculotherapy by needlesOther
Also called auricular acupuncture
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 seedsOther
Also called auricular acupuncture 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: auriculotherapy by seeds |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: after 60 days
Secondary outcomes (1)
Stress Scale
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.
Measured: after 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leonice Fumiko Sato Kurebayashi, University of Sao Paulo
- Investigators
- Leonice FS Kurebayashi, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424072
- Sponsor's protocol ID
- CAAE: 0060.0.198.000-09
- Status last verified
- Apr 2013
- First submitted
- 23 Aug 2011
- Last updated
- 31 May 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicability of Auriculotherapy as a Strategy for Stress and Coping in Nursing Professionals
- ClinicalTrials.gov ID
- NCT01424072
- Acronym / sponsor ID
- CAAE: 0060.0.198.000-09
- Conditions
- Stress, Psychological, Coping Behavior
- Keywords
- stress psychological, coping behavior
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Posted 31 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: auriculotherapy by needlesThe 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 seeds | Experimental | Other: auriculotherapy by seedsThe investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions. |
Who may qualify
- Ages
- 23 to 61 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Average and high score by the List of Stress Symptoms
- Voluntary participation in the study
- Availability of time for submission to the sessions
Key exclusion criteria (3 listed)
- Pregnancy
- Medical license or vacation during the period
- Low score of stress
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auriculotherapy by needlesAlso: auricular acupunctureThe 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 | Auriculotherapy by needles |
| auriculotherapy by seedsAlso: auricular acupuncture by seedsWe 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 | Auriculotherapy by seeds |
Primary outcome
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).
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).
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).
1 secondary outcome
Stress Scale
Time frame: after 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonice FS Kurebayashi principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing auriculotherapy by needles and auriculotherapy by seeds in people with Stress, Psychological and Coping Behavior, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coping Strategy: Domain Social Support(After 60 Days) (time frame: after 60days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2013.