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

Anxiety Clinical Trial

Official title:

Acupuncture Treatment in Adults Undergoing Diagnostic Upper Gastrintestinal Endoscopy: A Double-Blind Placebo Controlled Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00449241
• Other study ID #: CRE-2006.227-T
• Status: Recruiting
• Phase: N/A
• First received: March 19, 2007
• Last updated: March 19, 2007
• Start date: November 2006
• Est. completion date: July 2007

Study information

• Verified date: March 2007
• Source: Chinese University of Hong Kong
• Contact: Wing Wa Leung, Master
• Phone: 26323915
• Email: leungww[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety

Intervention

Device:
• Acupuncture

Locations

Country	Name	City	State
China	Combined Endoscopy Centre, Alices Ho Miu Ling Netherole Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety elicited during EGD
Secondary	Overall tolerance, overall satisfaction, patient’s willingness to repeat procedure and recovery time