Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass

NCT ID: NCT01231776

Last Updated: 2011-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-02-28

Brief Summary

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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

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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.

Conditions

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Heart Valve Diseases Cardiopulmonary Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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control group

Group Type NO_INTERVENTION

electronic acupuncture

Intervention Type OTHER

applying a stimula on neiguang and shenmen through electronic acupuncture

acupuncture preoperative

acupuncture before operation for one week

Group Type ACTIVE_COMPARATOR

electronic acupuncture

Intervention Type OTHER

applying a stimula on neiguang and shenmen through electronic acupuncture

acupuncture in hospital

acupuncture all the time in hospital

Group Type ACTIVE_COMPARATOR

electronic acupuncture

Intervention Type OTHER

applying a stimula on neiguang and shenmen through electronic acupuncture

Interventions

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electronic acupuncture

applying a stimula on neiguang and shenmen through electronic acupuncture

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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the departement of cardiovascular surgery, xijing hospital

Principal Investigators

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zhang jinzhou, MD

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital

Locations

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Zhang Jinzhou

Xi'an, Shaanxi, China

Site Status ENROLLING_BY_INVITATION

Zhang Jinzhou

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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zhang jinzhou, MD

Role: CONTACT

86-029771022

wen aidong, MD

Role: CONTACT

86-29-84771162

Facility Contacts

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zhang jinzhou, MD

Role: primary

86-29-84771022

Other Identifiers

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20100926

Identifier Type: -

Identifier Source: org_study_id

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