Auricular AcupressureAAANCT01056458
Auricular Acupressure for Perimenopausal Women With Anxiety
A study testing auricular acupressure in people with Auricular Acupressure and Anxiety, run by Chang-Hua Hospital at 1 site in Taiwan.
Trial summary
This study is expected to show auricular acupressure therapy help to improve the anxiety symptoms of perimenopausal and early postmenopausal women, looking forward to developing a convenient, safe and effective way to reduce the use of sedative hypnotics and their dependencies, thereby improving their quality of life. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Auricular Acupressure, Anxiety, Menopause
- What is being tested?
- auricular acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2010to Jan 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 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age between 40 to 60 years
- irregular menstrual cycle less than 12 months or no menstrual cycle less than 10 years
- FSH level>= 14 IU/L
- Brief symptom rating scale total scores>= 6
Who cannot join
- severe medical conditions
- substance dependence or abuse
- contraindication of BZDs
- contraindication of acupressure
- other primary anxiety disorder and major psychosis
- use hormone therapy
- use herb medicine
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang-Hua Hospital
Changhua, 513
Ching-Ling Kao, MD, 4886-4-8298686 ext. 1805, chinglingkao@gmail.com
Ching-Ling Kao, MD
About this study
Official title: Effect of Auricular Acupressure on Perimenopausal and Early Postmenopausal Women With Anxiety: a Double Blinded, Randomized and Controlled Study
This study is expected to show auricular acupressure therapy help to improve the anxiety symptoms of perimenopausal and early postmenopausal women, looking forward to developing a convenient, safe and effective way to reduce the use of sedative hypnotics and their dependencies, thereby improving their quality of life.
Read the detailed description
There are several stages of women while they were particularly vulnerable to anxiety and insomnia , especially in the pre-menstruation, pregnancy, postpartum, and menopause stage. Sleep problems are common in menopausal and postmenopausal women, its prevalence can be based on research from 15% to 60%. As for anxiety, the prevalence of women in this population can reach 53.7%. Several studies overseas have already pointed out that the improvement of acupuncture for anxiety disorders have had pretty good results. As auricular acupressure with a simple operation and the advantages of non-invasive, our interest is to explore the clinical benefit of combined auricular acupressure and medical therapy on anxiety and insomnia improvement in menopausal and early post-menopausal women. We design a double-blind, randomized controlled study, the subjects are ninety 40 to 60 years old women, during perimenopause and early postmenopause who are accompanied by anxiety symptoms. They were randomly divided into experimental and control groups, use the tape of ear adhesive beads on shenmen and subcortical area of both ears after three meals and before bed for three minutes each area with alternating ears, twice a week to replace paste. A total treatment time is eight times and a total of four weeks. Primary efficacy assessment (primary outcome measure) for the Hamilton Anxiety Rating Scale (HAMA) total score change. Secondary efficacy assessments (secondary outcome measure) for: 1) Menopause Rating Scale (MRS) scores; 2) Short Form Health Survey (SF-36) scores; 3) Clinical Global Impression-Severity (CGI-S) scores; and 4) Clinical Global Impression-Improvement (CGI-I) score changes.
- Conditions
- Auricular Acupressure, Anxiety, Menopause, Insomnia
- Being tested
- auricular acupressure, sham acupressure
- Keywords
- acupressure, perimenopause, menopause, anxiety, life quality, insomnia
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auricular acupressureOther
Also called acupressure
use the tape of ear adhesive beads on shenmen and subcortical area of both ears after three meals and before bed for three minutes each area with alternating ears, twice a week to replace paste.
sham acupressureOther
Also called acupressure
use only tape without ear adhesive beads under the same ways
| Study group | Role | What they receive |
|---|---|---|
| Acupressure acupressure | Active comparator | Not described Receives: Other: auricular acupressure |
| sham acupressure | Sham comparator | Not described Receives: Other: sham acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Rating Scale
Measured: 4 weeks aftter ear acupressure
Secondary outcomes (1)
Menopause Rating Scale,Short Form Health Survey(SF-36),CGI
Measured: 4 weeks aftter ear acupressure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2011 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auricular AcupressureStudies 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang-Hua Hospital
- Sponsor type
- Other government
- Collaborators
- China Medical University Hospital
- Investigators
- Ching-Ling Kao, MD, Principal investigator, Chang-Hua Hospital, Department of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056458
- Sponsor's protocol ID
- 98DMR291
- Acronym
- AAA
- Status last verified
- Jan 2010
- First submitted
- 25 Jan 2010
- Last updated
- 31 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Auricular Acupressure on Perimenopausal and Early Postmenopausal Women With Anxiety: a Double Blinded, Randomized and Controlled Study
- ClinicalTrials.gov ID
- NCT01056458
- Acronym / sponsor ID
- AAA / 98DMR291
- Conditions
- Auricular Acupressure, Anxiety, Menopause, Insomnia
- Keywords
- acupressure, perimenopause, menopause, anxiety, life quality, insomnia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Chang-Hua HospitalOther government
- Collaborators
- China Medical University Hospital
- Study start
- Jan 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 26 Jan 2010 (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 is expected to show auricular acupressure therapy help to improve the anxiety symptoms of perimenopausal and early postmenopausal women, looking forward to developing a convenient, safe and effective way to reduce the use of sedative hypnotics and their dependencies, thereby improving their quality of life.
Detailed description
There are several stages of women while they were particularly vulnerable to anxiety and insomnia , especially in the pre-menstruation, pregnancy, postpartum, and menopause stage. Sleep problems are common in menopausal and postmenopausal women, its prevalence can be based on research from 15% to 60%. As for anxiety, the prevalence of women in this population can reach 53.7%. Several studies overseas have already pointed out that the improvement of acupuncture for anxiety disorders have had pretty good results. As auricular acupressure with a simple operation and the advantages of non-invasive, our interest is to explore the clinical benefit of combined auricular acupressure and medical therapy on anxiety and insomnia improvement in menopausal and early post-menopausal women. We design a double-blind, randomized controlled study, the subjects are ninety 40 to 60 years old women, during perimenopause and early postmenopause who are accompanied by anxiety symptoms. They were randomly divided into experimental and control groups, use the tape of ear adhesive beads on shenmen and subcortical area of both ears after three meals and before bed for three minutes each area with alternating ears, twice a week to replace paste. A total treatment time is eight times and a total of four weeks. Primary efficacy assessment (primary outcome measure) for the Hamilton Anxiety Rating Scale (HAMA) total score change. Secondary efficacy assessments (secondary outcome measure) for: 1) Menopause Rating Scale (MRS) scores; 2) Short Form Health Survey (SF-36) scores; 3) Clinical Global Impression-Severity (CGI-S) scores; and 4) Clinical Global Impression-Improvement (CGI-I) score changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupressure acupressure | Active comparator | Other: auricular acupressure |
| sham acupressure | Sham comparator | Other: sham acupressure |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age between 40 to 60 years
- irregular menstrual cycle less than 12 months or no menstrual cycle less than 10 years
- FSH level>= 14 IU/L
- Brief symptom rating scale total scores>= 6
Key exclusion criteria (7 listed)
- severe medical conditions
- substance dependence or abuse
- contraindication of BZDs
- contraindication of acupressure
- other primary anxiety disorder and major psychosis
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 |
|---|---|---|
| auricular acupressureAlso: acupressureuse the tape of ear adhesive beads on shenmen and subcortical area of both ears after three meals and before bed for three minutes each area with alternating ears, twice a week to replace paste. | Other | Acupressure acupressure |
| sham acupressureAlso: acupressureuse only tape without ear adhesive beads under the same ways | Other | sham acupressure |
Primary outcome
Hamilton Anxiety Rating Scale
Time frame: 4 weeks aftter ear acupressure
1 secondary outcome
Menopause Rating Scale,Short Form Health Survey(SF-36),CGI
Time frame: 4 weeks aftter ear acupressure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2010.
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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.
Ching-Ling Kao, MD principal investigator
Chang-Hua Hospital, Department of Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing auricular acupressure in people with Auricular Acupressure and Anxiety, run by Chang-Hua Hospital at 1 site in Taiwan.
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 4 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: status not confirmed, as of the sponsor's last update on 31 May 2010. 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 Taiwan. 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.
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 Ching-Ling Kao, MD (886-4-8298686 ext. 1805, chinglingkao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (time frame: 4 weeks aftter ear acupressure). 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 2010.