AnxietyPhase 2NCT01627444
Acupuncture in Mothers of Very Low Birth Weight Infants
A Phase 2 study testing Ear acupuncture in people with Anxiety, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Does ear acupuncture reduce anxiety in mother of very low birth weight infants? Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Ear acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2011to Aug 2012
- Phase
- Phase 2
- 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 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- can read and write in portuguese
Who cannot join
- breastfeeding contraindication
- use of lactogogues
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Universitário de Londrina
Londrina, Paraná, 86038-350
Mariana L Haddad, RN, MSc, 55 43 33246030, mari.tradu@gmail.com
Mariana L Haddad, RN, MSc
About this study
Official title: Ear Acupuncture for Anxiety in Mothers of Very Low Birth Weight Infants
Does ear acupuncture reduce anxiety in mother of very low birth weight infants?
- Conditions
- Anxiety
- Being tested
- Ear acupuncture
- Keywords
- Acupuncture, Anxiety, Human Milk, Very low birth weight infants, Mother of very low birth weight infants
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ear acupunctureProcedure or surgery
Ear acupuncture based on Chinese Map: ShenMen, Anxiety 1 and 2, Tension, Muscular relaxation.
| Study group | Role | What they receive |
|---|---|---|
| ear acupuncture | Experimental | Not described Receives: Procedure: Ear acupuncture |
| Placebo acupuncture | Placebo comparator | No needle insertion, only stickers on acupuncture points. Receives: Procedure: Ear acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced anxiety
Measured: at least 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Haddad, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627444
- Sponsor's protocol ID
- Acupuncture_doctorate
- Status last verified
- Jun 2012
- First submitted
- 20 Jun 2012
- Last updated
- 25 Jun 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ear Acupuncture for Anxiety in Mothers of Very Low Birth Weight Infants
- ClinicalTrials.gov ID
- NCT01627444
- Acronym / sponsor ID
- Acupuncture_doctorate
- Conditions
- Anxiety
- Keywords
- Acupuncture, Anxiety, Human Milk, Very low birth weight infants, Mother of very low birth weight infants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 25 Jun 2012 (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.
Does ear acupuncture reduce anxiety in mother of very low birth weight infants?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ear acupuncture | Experimental | Procedure: Ear acupuncture |
| Placebo acupuncture | Placebo comparator | Procedure: Ear acupunctureNo needle insertion, only stickers on acupuncture points. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- can read and write in portuguese
Key exclusion criteria (2 listed)
- breastfeeding contraindication
- use of lactogogues
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 acupunctureEar acupuncture based on Chinese Map: ShenMen, Anxiety 1 and 2, Tension, Muscular relaxation. | Procedure or surgery | Placebo acupuncture, ear acupuncture |
Primary outcome
Reduced anxiety
Time frame: at least 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
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 Ear acupuncture in people with Anxiety, 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 25 Jun 2012. 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. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariana L Haddad, RN, MSc (55 43 33246030, mari.tradu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced anxiety (time frame: at least 2 weeks). 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 25 Jun 2012.