NCT01231776

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.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 23, 2011

Status Verified

September 1, 2010

Enrollment Period

4 months

First QC Date

October 28, 2010

Last Update Submit

February 21, 2011

Conditions

Keywords

cardiopulmonary bypasssleepacupuncture

Outcome Measures

Primary Outcomes (1)

  • multiple monitoring for sleeping

    24 hours

Study Arms (3)

control group

NO INTERVENTION
Other: electronic acupuncture

acupuncture preoperative

ACTIVE COMPARATOR

acupuncture before operation for one week

Other: electronic acupuncture

acupuncture in hospital

ACTIVE COMPARATOR

acupuncture all the time in hospital

Other: electronic acupuncture

Interventions

applying a stimula on neiguang and shenmen through electronic acupuncture

acupuncture in hospitalacupuncture preoperativecontrol group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • neurological disease,mentality disorder
  • abuse of alcohol
  • long history of smoking
  • sleep disorder before admitting to hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Zhang Jinzhou

Xi'an, Shaanxi, 710032, China

ENROLLING BY INVITATION

Zhang Jinzhou

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • zhang jinzhou, MD

    Xijing Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 28, 2010

First Posted

November 1, 2010

Study Start

September 1, 2010

Primary Completion

January 1, 2011

Study Completion

February 1, 2011

Last Updated

February 23, 2011

Record last verified: 2010-09

Locations