StressPhase 2NCT01141374
Application of Auriculotherapy on Nursing Professional Stress Levels
A Phase 2 study testing auriculotherapy by needles and auriculotherapy by seeds in people with Stress, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Objectives: Randomized controlled trial aimed to assess stress levels in nursing staff and review the auriculotherapy effectiveness through semi-permanent needles and seeds. Read more about this study
- Who is it for?
- Ages 23 to 61 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- 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 Jun 2010
- Phase
- Phase 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 da Universidade de São Paulo
São Paulo, São Paulo, 05508-000
About this study
Official title: Analysis of the Application of Different Forms in Auriculotherapy on Nursing Professional Stress Levels
Objectives: Randomized controlled trial aimed to assess stress levels in nursing staff and review the auriculotherapy effectiveness through semi-permanent needles and seeds.
Read the detailed description
Seventy five participants with average and high scores on the Stress Symptoms List (LSS) were divided in 3 groups (control, needles and seeds).
They were evaluated at the baseline, fourth and eighth sessions and 15-day follow-up and received 8 sessions through Shenmen, Kidney and Brainstem points.
- Conditions
- Stress
- Being tested
- auriculotherapy by needles, auriculotherapy by seeds
- Keywords
- Stress
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 without treatment | 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.
Stress Levels After 4 Sessions (2nd Evaluation)
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 30 days
Secondary outcomes (1)
Stress Levels(3rd and 4th Evaluation)
Scale Information: Stress Symptoms List (LSS) with 60 items Low score (better outcome): 12/29 points; Medium score: 30/60 points; High score: 61/120 points; Very high score (worse outcome): >120 points.
Measured: after 60 and 75 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2010
- Study completionJun 2010
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 StressStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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 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
- Maria Julia P Silva, Study director, Escola de Enfermagem da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01141374
- Sponsor's protocol ID
- SISNEP
- Status last verified
- Jan 2013
- First submitted
- 4 Jun 2010
- Last updated
- 24 Jan 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 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Application of Different Forms in Auriculotherapy on Nursing Professional Stress Levels
- ClinicalTrials.gov ID
- NCT01141374
- Acronym / sponsor ID
- SISNEP
- Conditions
- Stress
- Keywords
- Stress
- Phase
- Phase 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
- Apr 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 10 Jun 2010 (estimated)
- Results
- Posted 23 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives: Randomized controlled trial aimed to assess stress levels in nursing staff and review the auriculotherapy effectiveness through semi-permanent needles and seeds.
Detailed description
Seventy five participants with average and high scores on the Stress Symptoms List (LSS) were divided in 3 groups (control, needles and seeds).
They were evaluated at the baseline, fourth and eighth sessions and 15-day follow-up and received 8 sessions through Shenmen, Kidney and Brainstem points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group without treatment | 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
Stress Levels After 4 Sessions (2nd Evaluation)
Time frame: after 30 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.
1 secondary outcome
Stress Levels(3rd and 4th Evaluation)
Time frame: after 60 and 75 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 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.
Maria Julia P Silva study director
Escola de Enfermagem da Universidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing auriculotherapy by needles and auriculotherapy by seeds in people with Stress, 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 24 Jan 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 phase mean?
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 23 Jan 2012). 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?
Stress Levels After 4 Sessions (2nd Evaluation) (time frame: after 30 days). 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 24 Jan 2013.