Acupuncture Improves Sleep in Patients Undergoing Cardiopulmonary Bypass

Heart Valve Diseases Clinical Trial

Official title:

Study of Acupuncture of Traditional Chinese Medicine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01231776
• Other study ID #: 20100926
• Status: Recruiting
• Phase: N/A
• First received: October 28, 2010
• Last updated: February 21, 2011
• Start date: September 2010
• Est. completion date: February 2011

Study information

• Verified date: September 2010
• Source: Xijing Hospital
• Contact: zhang jinzhou, MD
• Phone: 86-029771022
• Email: jinzhouzhang2006[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Heart Valve Diseases

Intervention

Other:
• electronic acupuncture
applying a stimula on neiguang and shenmen through electronic acupuncture

Locations

Country	Name	City	State
China	Zhang Jinzhou	Xi`an	Shaanxi
China	Zhang Jinzhou	Xi`an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	multiple monitoring for sleeping		24 hours	Yes