AnxietyNCT00449241
Acupuncture Treatment in Adults Undergoing Diagnostic OGD : A Double-Blind Placebo Controlled Randomized Trial
A study testing Acupuncture in people with Anxiety, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
To find out how the application of acupuncture needles to the proposed acupuncture points: Heart 7 (HT 7) and Pericardium 6 (PC 6) for reducing anxiety during Esophago-gastro-duodenoscopy (EGD) Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- How many people
- 210 participants
- Where
- 1 siteChina
- Study dates
- Nov 2006to Jul 2007
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-70 undergoing elective unsedatant diagnostic EGD
- belonging to American Society of Anesthesia (ASA) classes 1 to 2
Who cannot join
- History of gastrectomy, esophagectomy, Whipple's operation and other gastrointestinal operations
- ASA class 3 to 4
- Pregnancy
- Allergy to acupuncture needles
- Request sedation
- Previous experiences of EGD
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Combined Endoscopy Centre, Alices Ho Miu Ling Netherole Hospital
Hong Kong
Wing Wa Leung, Master, 26323915, leungww@surgery.cuhk.edu.hk
Lik Man Mui, FRCS
About this study
Official title: Acupuncture Treatment in Adults Undergoing Diagnostic Upper Gastrintestinal Endoscopy: A Double-Blind Placebo Controlled Randomized Trial
To find out how the application of acupuncture needles to the proposed acupuncture points: Heart 7 (HT 7) and Pericardium 6 (PC 6) for reducing anxiety during Esophago-gastro-duodenoscopy (EGD)
Read the detailed description
Acupuncture is being used as one part of Chinese medicine for more than 2,500 years in treating diseases. Recent functional magnetic resonance imaging demonstrated that acupuncture can suppress the "pain" area in the brain so as to reduce the pain that felt by human subjects. Western medicine proposed the acupuncture mechanisms as to "provoke the release of endogenous substances" from central nervous system so in reducing pain. Many studies had been done using acupuncture in reducing pain for post-operation period, however, most of them were not very systematic and even some of them are leak of control group. Furthermore, to our knowledge, the use of acupuncture for reducing anxiety during EGD has not been previously investigated.
- Conditions
- Anxiety
- Being tested
- Acupuncture
- Keywords
- Acupuncture, Endoscopy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety elicited during EGD
Secondary outcomes (1)
Overall tolerance, overall satisfaction, patient's willingness to repeat procedure and recovery time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2007 (estimated)
- Study startNov 2006
- Study completionJul 2007 (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 Chinese University of Hong KongThe 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
- Double blind
- Enrolment
- 210 participants
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Wing Wa Leung, Master, Principal investigator, Department of Surgery, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449241
- Sponsor's protocol ID
- CRE-2006.227-T
- Status last verified
- Mar 2007
- First submitted
- 19 Mar 2007
- Last updated
- 20 Mar 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Treatment in Adults Undergoing Diagnostic Upper Gastrintestinal Endoscopy: A Double-Blind Placebo Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT00449241
- Acronym / sponsor ID
- CRE-2006.227-T
- Conditions
- Anxiety
- Keywords
- Acupuncture, Endoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Nov 2006
- Study completion
- Jul 2007 (estimated)
- First posted
- 20 Mar 2007 (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.
To find out how the application of acupuncture needles to the proposed acupuncture points: Heart 7 (HT 7) and Pericardium 6 (PC 6) for reducing anxiety during Esophago-gastro-duodenoscopy (EGD)
Detailed description
Acupuncture is being used as one part of Chinese medicine for more than 2,500 years in treating diseases. Recent functional magnetic resonance imaging demonstrated that acupuncture can suppress the "pain" area in the brain so as to reduce the pain that felt by human subjects. Western medicine proposed the acupuncture mechanisms as to "provoke the release of endogenous substances" from central nervous system so in reducing pain. Many studies had been done using acupuncture in reducing pain for post-operation period, however, most of them were not very systematic and even some of them are leak of control group. Furthermore, to our knowledge, the use of acupuncture for reducing anxiety during EGD has not been previously investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-70 undergoing elective unsedatant diagnostic EGD
- belonging to American Society of Anesthesia (ASA) classes 1 to 2
Key exclusion criteria (6 listed)
- History of gastrectomy, esophagectomy, Whipple's operation and other gastrointestinal operations
- ASA class 3 to 4
- Pregnancy
- Allergy to acupuncture needles
- Request sedation
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 |
|---|---|---|
| Acupuncture | Device | – |
Primary outcome
Anxiety elicited during EGD
1 secondary outcome
Overall tolerance, overall satisfaction, patient's willingness to repeat procedure and recovery time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2007.
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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.
Wing Wa Leung, Master principal investigator
Department of Surgery, CUHK
1 site 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 Anxiety, run by Chinese University of Hong Kong at 1 site in China.
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 6 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 20 Mar 2007. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wing Wa Leung, Master (26323915, leungww@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety elicited during EGD. 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 20 Mar 2007.