Effects of acupuncture on mental status and sleep quality in hypertensive patients with anxiety and depression: A protocol of randomized controlled trail

Phase 1

• Conditions: High blood pressure is a clinically common chronic mental and physical illness, often accompanied by psychological disorders such as anxiety and depression. As a classic supplementary alternative therapy, there is evidence that acupuncture has a good effect on improving the mental state and sleep quality of people with high blood pressure and anxiety-associated depression.; High blood pressure; anxiety-associated depression; acupuncture; double -blind controlled trial

• Registration Number: TCTR20230228003
• Lead Sponsor: Huaying Wang

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-28
• Last Update Posted: 19 August 2024
• Study Completion: 2025-04-14

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

(1) Patients who meet the diagnostic criteria for high blood pressure and are accompanied by anxiety and depression;
(2) PSQI score > 7 points;
(3) Age between 18 years and 79 years, regardless of gender;
(4) Patients voluntarily participate in the trial and sign an informed consent.

Exclusion Criteria

(1) Patients with severe complications of high blood pressure and other severe organ dysfunction;
(2) Patients with serious skin infections and dysfunction of blood coagulation;
(3) Patients with serious mental illness;
(4) Pregnant or lactating women;
(5) Patients with a history of allergies to components of the drug in this study;
(6) Subjects participating in clinical trials of other drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PSQI score 4 weeks including 7 items, each entry is 0 to 3 points, and the higher the score, the worse the quality of sleep

Secondary Outcome Measures

Name	Time	Method
Anxiety status assessment 4 weeks using the Generalized Anxiety Disorder (GAD-7)[17], mild: 5 to 9 points; moderate: 10 to 14 points; and severe: 15 to 21 points.