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

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Postoperative Pain; Acupuncture

• Study Type: Observational
• Enrollment (Estimated): 110

Contacts and Locations

• Study Contact: Name: Bin Yang doctor; Phone Number: 1385998603; Email: yangbin4332@outlook.com

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Recruiting
      • First Affiliated Hospital of Xiamen University
      • Contact: Bin Yang doctor; Phone Number: +86 13950374558; Email: 2389899106@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing breast cancer surgery with general anesthesia in the hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients undergoing breast cancer surgery with general anesthesia in the hospital

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): October 13, 2026
• Study Completion (Estimated): November 13, 2026

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 25, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 25, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: FirstAHXiamenU-YB-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No