NCT00449241

Brief 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
210

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

March 20, 2007

Status Verified

March 1, 2007

First QC Date

March 19, 2007

Last Update Submit

March 19, 2007

Conditions

Anxiety

Keywords

Acupuncture, Endoscopy

Outcome Measures

Primary Outcomes (1)

  • Anxiety elicited during EGD

Secondary Outcomes (1)

  • Overall tolerance, overall satisfaction, patient's willingness to repeat procedure and recovery time

Interventions

AcupunctureDEVICE

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Combined Endoscopy Centre, Alices Ho Miu Ling Netherole Hospital

Hong Kong, China

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Wing Wa Leung, Master

    Department of Surgery, CUHK

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wing Wa Leung, Master

CONTACT

26323915leungww@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 19, 2007

First Posted

March 20, 2007

Study Start

November 1, 2006

Study Completion

July 1, 2007

Last Updated

March 20, 2007

Record last verified: 2007-03

Locations

CN(1)