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Application Effect of External Counterpulsation Combined with Five-Element Music Therapy on Patients with Coronary Heart Disease and Insomnia

Application Effect of External Counterpulsation Combined with Five-Element Music Therapy on Patients with Coronary Heart Disease and Insomnia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000731
Enrollment
Unknown
Registered
2026-03-25
Start date
2026-01-19
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary heart disease with insomnia

Interventions

Control Group:Administer routine treatment and routine nursing care in the cardiology department
Enhanced External Counterpulsation Group:Administer enhanced external counterpulsation therapy on the basis of the control group's intervention
Five-Element Music Group:Receive Five-Element Music Therapy on the basis of the control group's intervention
Combined Intervention Group:On the basis of the control group's intervention, simultaneously receive enhanced external counterpulsation and Five-Element Music Therapy

Sponsors

Changzhi Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 119 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for stable coronary heart disease; (2) Simultaneously satisfy both Western medicine and Traditional Chinese Medicine diagnostic criteria for insomnia; (3) Pittsburgh Sleep Quality Index (PSQI) score > 7 points; (4) Age = 18 years old; (5) Normal hearing, consciousness, thinking, and language communication; (6) Voluntarily participate in this study, sign the informed consent form, and agree to cooperate with follow-up work after discharge.

Exclusion criteria

Exclusion criteria: (1) Moderate to severe aortic regurgitation; (2) Dissecting aortic aneurysm, thoracoabdominal aortic aneurysm, or cerebral aneurysm; (3) Moderate to severe pulmonary hypertension and/or right heart dysfunction; (4) Acute exacerbation of heart failure; (5) Hemorrhagic disorders, significant bleeding tendency, or use of anticoagulant medication with an INR > 2.0; (6) Thrombophlebitis, infectious lesions in the lower limbs, or arterial stent implantation; (7) Uncontrolled hypertension (> 170/110 mmHg); (8) Arrhythmia that may cause malfunction of the external counterpulsation device's ECG-gating function; (9) Patients with concurrent tuberculosis or malignancy; (10) Concurrent severe mental illness or major depression; (11) Pregnancy.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Clinical Efficacy of Insomnia Symptoms;Traditional Chinese Medicine Syndrome Score;Clinical Efficacy of Traditional Chinese Medicine Syndrome;Systolic Blood Pressure;Diastolic Blood Pressure;Self-Rating Anxiety Scale Score;Self-Rating Depression Scale Score;Seattle Angina Questionnaire Score;Adverse Event Incidence Rate;

Countries

China

Contacts

Public ContactWang Jinnan

Changzhi Medical College

m18303430390@163.com18303430390

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026