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Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass

Primary Purpose

Heart Valve Diseases, Cardiopulmonary Bypass

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
electronic acupuncture
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Valve Diseases focused on measuring cardiopulmonary bypass, sleep, acupuncture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zhang Jinzhou
  • Zhang JinzhouRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Active Comparator

Arm Label

control group

acupuncture preoperative

acupuncture in hospital

Arm Description

acupuncture before operation for one week

acupuncture all the time in hospital

Outcomes

Primary Outcome Measures

multiple monitoring for sleeping

Secondary Outcome Measures

Full Information

First Posted
October 28, 2010
Last Updated
February 21, 2011
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01231776
Brief Title
Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass
Official Title
Study of Acupuncture of Traditional Chinese Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
February 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases, Cardiopulmonary Bypass
Keywords
cardiopulmonary bypass, sleep, acupuncture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Title
acupuncture preoperative
Arm Type
Active Comparator
Arm Description
acupuncture before operation for one week
Arm Title
acupuncture in hospital
Arm Type
Active Comparator
Arm Description
acupuncture all the time in hospital
Intervention Type
Other
Intervention Name(s)
electronic acupuncture
Intervention Description
applying a stimula on neiguang and shenmen through electronic acupuncture
Primary Outcome Measure Information:
Title
multiple monitoring for sleeping
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhang jinzhou, MD
Phone
86-029771022
Email
jinzhouzhang2006@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
wen aidong, MD
Phone
86-29-84771162
Email
adwen-2004@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhang jinzhou, MD
Organizational Affiliation
Xijing Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhang Jinzhou
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Enrolling by invitation
Facility Name
Zhang Jinzhou
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhang jinzhou, MD
Phone
86-29-84771022
Email
jinzhouzhang2006@yahoo.com

12. IPD Sharing Statement

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Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass

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