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Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass

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ClinicalTrials.gov Identifier: NCT01231776
Recruitment Status : Unknown
Verified September 2010 by Xijing Hospital.
Recruitment status was:  Recruiting
First Posted : November 1, 2010
Last Update Posted : February 23, 2011
Sponsor:
Information provided by:
Xijing Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Heart Valve Diseases Cardiopulmonary Bypass Other: electronic acupuncture Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Study of Acupuncture of Traditional Chinese Medicine
Study Start Date : September 2010
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. multiple monitoring for sleeping [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: zhang jinzhou, the departement of cardiovascular surgery, xijing hospital
ClinicalTrials.gov Identifier: NCT01231776     History of Changes
Other Study ID Numbers: 20100926
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: February 23, 2011
Last Verified: September 2010

Keywords provided by Xijing Hospital:
cardiopulmonary bypass
sleep
acupuncture

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