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Acupuncture Treatment in Adults Undergoing Diagnostic OGD : A Double-Blind Placebo Controlled Randomized Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00449241
First received: March 19, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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)


Condition Intervention
Anxiety
 Device: Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Acupuncture Treatment in Adults Undergoing Diagnostic Upper Gastrintestinal Endoscopy: A Double-Blind Placebo Controlled Randomized Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Anxiety elicited during EGD

Secondary Outcome Measures:
  • Overall tolerance, overall satisfaction, patient’s willingness to repeat procedure and recovery time

Estimated Enrollment: 210
Study Start Date: November 2006
Estimated Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-70 undergoing elective unsedatant diagnostic EGD
  • belonging to American Society of Anesthesia (ASA) classes 1 to 2

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00449241

Contacts
Contact: Wing Wa Leung, Master 26323915 leungww@surgery.cuhk.edu.hk

Locations
China
Combined Endoscopy Centre, Alices Ho Miu Ling Netherole Hospital Recruiting
Hong Kong, China
Contact: Wing Wa Leung, Master     26323915     leungww@surgery.cuhk.edu.hk    
Sub-Investigator: Lik Man Mui, FRCS            
Sub-Investigator: Janet, Fung Yee Lee, MD            
Sub-Investigator: Enders, Kwok Wai Ng, MD            
Sub-Investigator: James, Yun Wong Lau, MD            
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Wing Wa Leung, Master Department of Surgery, CUHK
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00449241     History of Changes
Other Study ID Numbers: CRE-2006.227-T
Study First Received: March 19, 2007
Last Updated: March 19, 2007
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Acupuncture, Endoscopy

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013