Memory ImpairmentNCT01492738
The Effect of Acupuncture on Anxiety and Working Memory
A study testing Acupuncture in people with Memory Impairment and Anxiety, run by National University of Health Sciences at 2 sites in United States.
Trial summary
This study endeavors to examine the relationship between acupuncture, anxiety, and performance on a test of working memory. In the study, all participants will complete the State-Trait Anxiety Inventory (STAI) survey to determine how anxious they are at the moment and how anxious they tend to be in general. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Memory Impairment, Anxiety
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to Dec 2011
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Undergraduate University student
- Fluent in English
- Willing to receive acupuncture
- Aged 18-30
- In good health
- Not pregnant
- Not breastfeeding
Who cannot join
- Not an Undergraduate University student
- Not fluent in English
- Unwilling to receive acupuncture
- Under 18 years of age or older than 30 years of age
- Chronic disease
- Pregnant
- Breastfeeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tiffani Kim Institute
Chicago, Illinois, 60654
A Center for Oriental Medicine
Wilmette, Illinois, 60091
About this study
This study endeavors to examine the relationship between acupuncture, anxiety, and performance on a test of working memory. In the study, all participants will complete the State-Trait Anxiety Inventory (STAI) survey to determine how anxious they are at the moment and how anxious they tend to be in general. Then ½ of subjects will receive acupuncture for 20 minutes and ½ will rest quietly for 20 minutes. After this period, all subjects will again complete the STAI survey. Then all subjects will complete the Automated Operations Span Task (AOSPAN) which is a computerized test of working memory. Statistical analysis will be performed to determine if acupuncture had any effect on State-level anxiety and on performance on the AOSPAN.
- Conditions
- Memory Impairment, Anxiety
- Being tested
- Acupuncture
- Keywords
- Acupuncture, anxiety, memory
- Medical subject headings
- Memory Disorders, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
After completing questionnaires and anxiety survey, a licensed acupuncturist will insert needles according to Clean Needle Technique into specific acupuncture points. Procedure will last 20 minutes.Following acupuncture treatment, participants will complete anxiety survey and memory test.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants will be asked to make themselves comfortable lying on a massage table for 20 minutes. |
| Acupuncture group | Active comparator | Acupuncture group will receive one acupuncture treatment for twenty minutes. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety level
Participants will complete the State-Trait Anxiety Inventory survey to see how anxious they are initially; after acupuncture treatment or quiet resting, they will complete the survey again to see how anxious they are after the intervention.
Measured: Baseline and after1 hour
Memory task
Following acupuncture treatment or resting control, participants will complete a standardized memory test (AOSPAN) to see if intervention affects memory.
Measured: After 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory ImpairmentStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Bussell, MSOM, LAc, Principal investigator, National University of Health SciencesHui Yan Cai, PhD, LAc, Study director, National University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492738
- Sponsor's protocol ID
- NUHS H1011
- Status last verified
- Apr 2015
- First submitted
- 1 Dec 2011
- Last updated
- 15 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Acupuncture on Anxiety and Working Memory
- ClinicalTrials.gov ID
- NCT01492738
- Acronym / sponsor ID
- NUHS H1011
- Conditions
- Memory Impairment, Anxiety
- Keywords
- Acupuncture, anxiety, memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National University of Health SciencesUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Dec 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.
This study endeavors to examine the relationship between acupuncture, anxiety, and performance on a test of working memory. In the study, all participants will complete the State-Trait Anxiety Inventory (STAI) survey to determine how anxious they are at the moment and how anxious they tend to be in general. Then ½ of subjects will receive acupuncture for 20 minutes and ½ will rest quietly for 20 minutes. After this period, all subjects will again complete the STAI survey. Then all subjects will complete the Automated Operations Span Task (AOSPAN) which is a computerized test of working memory. Statistical analysis will be performed to determine if acupuncture had any effect on State-level anxiety and on performance on the AOSPAN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants will be asked to make themselves comfortable lying on a massage table for 20 minutes. |
| Acupuncture group | Active comparator | Procedure: AcupunctureAcupuncture group will receive one acupuncture treatment for twenty minutes. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Undergraduate University student
- Fluent in English
- Willing to receive acupuncture
- Aged 18-30
- In good health
Key exclusion criteria (7 listed)
- Not an Undergraduate University student
- Not fluent in English
- Unwilling to receive acupuncture
- Under 18 years of age or older than 30 years of age
- Chronic disease
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 |
|---|---|---|
| AcupunctureAfter completing questionnaires and anxiety survey, a licensed acupuncturist will insert needles according to Clean Needle Technique into specific acupuncture points. Procedure will last 20 minutes.Following acupuncture treatment, participants will complete anxiety survey and memory test. | Procedure or surgery | Acupuncture group |
Primary outcome
Change in anxiety level
Time frame: Baseline and after1 hour
Participants will complete the State-Trait Anxiety Inventory survey to see how anxious they are initially; after acupuncture treatment or quiet resting, they will complete the survey again to see how anxious they are after the intervention.
Memory task
Time frame: After 1 hour
Following acupuncture treatment or resting control, participants will complete a standardized memory test (AOSPAN) to see if intervention affects memory.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2015.
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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.
Jason Bussell, MSOM, LAc principal investigator
National University of Health Sciences
Hui Yan Cai, PhD, LAc study director
National University of Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Memory Impairment and Anxiety, run by National University of Health Sciences at 2 sites in United States.
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 7 inclusion and 7 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 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in anxiety level (time frame: Baseline and after1 hour). The study lists 2 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 15 Apr 2015.