Effects of acupuncture on anxiety, depression and quality of life of patients with coronary artery disease after percutaneous coronary intervention: study protocol for a randomized, blinded, placebo-controlled trial

Phase 1

• Conditions: Anxiety and depression are prominent in patients after percutaneous coronary interventions (PCI) for coronary artery disease (CAD), thus affecting patients&#039

• Registration Number: TCTR20220629008
• Lead Sponsor: Xiaoxia Wang

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-29
• Study Completion: 2024-08-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

1. CAD patients with anxiety and depression after PCI; Hamilton Anxiety Rating Scale (HAMA) score at least7 points, and Hamilton Depression Rating Scale (HAMD) score at least14 points;
2.Aged 18 to 85;
3.No anti-anxiety or depression medication within the last 2 weeks;
4.Voluntarily accepted the random grouping and signed the informed consent form.

Exclusion Criteria

1.Patients with combined severe or unstable cardiac, cerebral, hepatic, renal, endocrine, hematological and other medical diseases;
2.Patients with progressive development or very poor prognosis, such as severe infections, severe water-electrolyte disorders, acid-base imbalance;
3. Patients with severe anxiety and depression, requiring oral anti-anxiety and depression drugs;
4. Patients with severe cognitive dysfunction who are unable to communicate;
5.Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hamilton Anxiety Scale (HAMA) 6 days The scale consists of 14 items, and each entry is scored on a scale of 0 to 3. The cumulative entry scores are summed to a total HAMA score, with a total score range of 0 to 42.

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Scale (HAMD) 6 days We used a 17-item version for evaluation, with evaluation items including despair, anxiety, sleep disorders, weight, cognitive impairment, day and night change, and retardation.