Inclusion Criteria:EAEIRTSOSAANCT01275989
Ear Acupuncture Effectiveness In Reducing The Signs And Symptoms Of Stress And Anxiety
A study testing Ear acupuncture in people with Inclusion Criteria: and Voluntary Participation in the Study With Available Time for Submission to the Sessions, Which Occur Over Two Months., run by University of Sao Paulo.
Trial summary
Randomized Controlled Trial found that levels of stress and anxiety of students ITIO, Ear and effective in reducing these levels. The LSS questionnaire and IDATE state were applied before, two months and two and a half months after the start of the applications, the STAI trait was applied once prior to the sessions. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Inclusion Criteria:, Voluntary Participation in the Study With Available Time for Submission to the Sessions, Which Occur Over Two Months., Have a Score of Stress Medium, High or Very High in the LSS Questionnaire, Completion of the STAI and General Form.
- What is being tested?
- Ear acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Nov 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Voluntary participation in the study with available time for submission to the sessions, which occur over two months.
- Have a score of stress medium, high or very high in the LSS questionnaire, completion of the STAI and general form.
Who cannot join
- Pregnant students. The only contraindication to this treatment is for pregnant women until the 3rd month of pregnancy
About this study
Official title: EAR ACUPUNCTURE EFFECTIVENESS IN REDUCING THE SIGNS AND SYMPTOMS OF STRESS AND ANXIETY
Randomized Controlled Trial found that levels of stress and anxiety of students ITIO, Ear and effective in reducing these levels. The LSS questionnaire and IDATE state were applied before, two months and two and a half months after the start of the applications, the STAI trait was applied once prior to the sessions. The sample comprised 56 individuals who had higher levels of stress above the average LSS 100 students who answered the questionnaires. Participants were divided randomly into three groups: control group with 15 patients without care, intervention group with 20 individuals using specific points for treatment and Group Sham at 21 points using individuals without indication for treatment of anxiety and stress. The results showed that the sham points decreased anxiety levels of participants.
Read the detailed description
After checking the levels of stress and anxiety of students and workers from a school of massage and acupuncture concluded that auricular acupuncture in this study had significant results in reducing anxiety levels with the use of points and Ear Handle, but more studies are necessary so that it can be said that these points have sedating and calming effects for anxiety.
- Conditions
- Inclusion Criteria:, Voluntary Participation in the Study With Available Time for Submission to the Sessions, Which Occur Over Two Months., Have a Score of Stress Medium, High or Very High in the LSS Questionnaire, Completion of the STAI and General Form., Exclusion Criteria:, Pregnant Students.
- Being tested
- Ear acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ear acupunctureOther
| Study group | Role | What they receive |
|---|---|---|
| 21 | Sham comparator | sham acupuncture Receives: Other: Ear acupuncture |
| 15 | No intervention | Control Receives: Other: Ear acupuncture |
| 20 | Active comparator | intervention Receives: Other: Ear acupuncture |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inclusion Criteria:Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Santander
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275989
- Sponsor's protocol ID
- 848/2009
- Acronym
- EAEIRTSOSAA
- Status last verified
- Jun 2010
- First submitted
- 12 Jan 2011
- Last updated
- 13 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EAR ACUPUNCTURE EFFECTIVENESS IN REDUCING THE SIGNS AND SYMPTOMS OF STRESS AND ANXIETY
- ClinicalTrials.gov ID
- NCT01275989
- Acronym / sponsor ID
- EAEIRTSOSAA / 848/2009
- Conditions
- Inclusion Criteria:, Voluntary Participation in the Study With Available Time for Submission to the Sessions, Which Occur Over Two Months., Have a Score of Stress Medium, High or Very High in the LSS Questionnaire, Completion of the STAI and General Form., Exclusion Criteria:, Pregnant Students.
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Santander
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized Controlled Trial found that levels of stress and anxiety of students ITIO, Ear and effective in reducing these levels. The LSS questionnaire and IDATE state were applied before, two months and two and a half months after the start of the applications, the STAI trait was applied once prior to the sessions. The sample comprised 56 individuals who had higher levels of stress above the average LSS 100 students who answered the questionnaires. Participants were divided randomly into three groups: control group with 15 patients without care, intervention group with 20 individuals using specific points for treatment and Group Sham at 21 points using individuals without indication for treatment of anxiety and stress. The results showed that the sham points decreased anxiety levels of participants.
Detailed description
After checking the levels of stress and anxiety of students and workers from a school of massage and acupuncture concluded that auricular acupuncture in this study had significant results in reducing anxiety levels with the use of points and Ear Handle, but more studies are necessary so that it can be said that these points have sedating and calming effects for anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 21 | Sham comparator | Other: Ear acupuncturesham acupuncture |
| 15 | No intervention | Other: Ear acupunctureControl |
| 20 | Active comparator | Other: Ear acupunctureintervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Voluntary participation in the study with available time for submission to the sessions, which occur over two months.
- Have a score of stress medium, high or very high in the LSS questionnaire, completion of the STAI and general form.
Key exclusion criteria (1 listed)
- Pregnant students. The only contraindication to this treatment is for pregnant women until the 3rd month of pregnancy
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 |
|---|---|---|
| Ear acupuncture | Other | 15, 20, 21 |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ear acupuncture in people with Inclusion Criteria: and Voluntary Participation in the Study With Available Time for Submission to the Sessions, Which Occur Over Two Months., run by University of Sao Paulo.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 13 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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.
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 13 Jan 2011.