A Clinical Follow-up Study on the Efficacy of Thumbtack Needle for Postoperative Sleep and Recovery Treatment

Recruiting

• Conditions: Postoperative Complications; Postoperative Pain; Acupuncture

• Registration Number: NCT06757023
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

Brief Summary

To understand the impact of thumb-tack needle therapy on postoperative sleep and recovery in patients who have undergone general anesthesia, and to explore the clinical significance of thumb-tack needle therapy in improving postoperative sleep quality, preventing postoperative sleep disorders, and promoting postoperative recovery

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-13
• Status Verified: 2024-12
• Study First Submitted: 2024-12-18
• Study First Submitted QC: 2024-12-25
• Last Update Submitted: 2024-12-25
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03
• Primary Completion: 2026-10-13
• Study Completion: 2026-11-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

1. Patients undergoing breast cancer surgery with general anesthesia in the hospital;
2. American Society of Anesthesiologists (ASA) classification I-II;
3. Women aged 18-55 years;
4. No history of chronic insomnia;
5. Individuals who have not taken sedative-hypnotic drugs within the past month.

Exclusion Criteria

1. Those who do not meet the aforementioned inclusion criteria;
2. A history of severe heart, brain, lung, or kidney diseases (such as acute coronary syndrome (ACS), severe heart failure classified as NYHA Class III or IV, severe arrhythmias, severe valvular disease; acute aortic disease, and severe peripheral vascular disease, etc.), or poor physical condition (including reduced exercise tolerance, multi-organ dysfunction, malnutrition, etc.);
3. A history of sleep disorders and psychiatric history;
4. Inability to receive thumb-tack needle treatment.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality index(PSQI)	1 day or 2 days before anesthesia exposure and 1, 3, and 7 days after anesthesia exposure.	Total scores range from 0 to 21, with higher scores indicating worse sleep quality.

Secondary Outcome Measures

Name	Time	Method
Later Recovery evaluated by QoR-40 questionnaire	QoR-40 score on the third day after surgery	The maximum total score is 200, with higher scores indicating better recovery quality

Trial Locations

Locations (1)

First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China