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Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Xijing Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01231776
First received: October 28, 2010
Last updated: February 21, 2011
Last verified: September 2010
History of Changes
  Purpose

Due to various causes, such as brain impairment, environment changes, anxious,et al. patients, who undergo cardiopulmonary bypass, often suffer from poor quality of sleep. In chinese traditional medicine, acupuncture can improve the quality of sleep in patients with sleeping disorder. But it remains acupuncture could improve the quality of sleep in patients with heart operations.


Condition Intervention
Heart Valve Diseases
Cardiopulmonary Bypass
 Other: electronic acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study of Acupuncture of Traditional Chinese Medicine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • multiple monitoring for sleeping [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: September 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group Other: electronic acupuncture
applying a stimula on neiguang and shenmen through electronic acupuncture
Active Comparator: acupuncture preoperative
acupuncture before operation for one week
 Other: electronic acupuncture
applying a stimula on neiguang and shenmen through electronic acupuncture
Active Comparator: acupuncture in hospital
acupuncture all the time in hospital
 Other: electronic acupuncture
applying a stimula on neiguang and shenmen through electronic acupuncture

Detailed Description:

60 patients are divided into three groups. control group: no any intervention; experiment group 1: acupuncture are used in patients before cardiac operation; experiment group 2: acupuncture are used through all the course in hospital.

before operation, before discharge, one month after operation, two month after operation, the quality of sleep are evaluated. and comparisons will be made in three groups.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aging:18yr--65yr
  • cardiopulmonary bypass
  • NYHA ≤II and EF≥50%
  • not illiterate person

Exclusion Criteria:

  • neurological disease,mentality disorder
  • abuse of alcohol
  • long history of smoking
  • sleep disorder before admitting to hospital
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01231776

Contacts
Contact: zhang jinzhou, MD 86-029771022 jinzhouzhang2006@yahoo.com
Contact: wen aidong, MD 86-29-84771162 adwen-2004@hotmail.com

Locations
China, Shaanxi
Zhang Jinzhou Enrolling by invitation
Xi`an, Shaanxi, China, 710032
Zhang Jinzhou Recruiting
Xi`an, Shaanxi, China, 710032
Contact: zhang jinzhou, MD     86-29-84771022     jinzhouzhang2006@yahoo.com    
Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: zhang jinzhou, MD Xijing Hospital
  More Information

No publications provided

Responsible Party: zhang jinzhou, the departement of cardiovascular surgery, xijing hospital
ClinicalTrials.gov Identifier: NCT01231776     History of Changes
Other Study ID Numbers: 20100926
Study First Received: October 28, 2010
Last Updated: February 21, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
cardiopulmonary bypass
sleep
acupuncture

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013