Recruiting NCT06757023
A Clinical Follow-up Study on the Efficacy of Thumbtack Needle for Postoperative Sleep and Recovery Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Postoperative Complications, Postoperative Pain, Acupuncture. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Primary outcome measures
- Pittsburgh sleep quality index(PSQI) [Time frame: 1 day or 2 days before anesthesia exposure and 1, 3, and 7 days after anesthesia exposure.]
Secondary outcome measures (1)
- Later Recovery evaluated by QoR-40 questionnaire [Time frame: QoR-40 score on the third day after surgery]
Eligibility criteria
Inclusion criteria
- Patients undergoing breast cancer surgery with general anesthesia in the hospital;
- American Society of Anesthesiologists (ASA) classification I-II;
- Women aged 18-55 years;
- No history of chronic insomnia;
- Individuals who have not taken sedative-hypnotic drugs within the past month.
Exclusion criteria
- Those who do not meet the aforementioned inclusion criteria;
- 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.);
- A history of sleep disorders and psychiatric history;
- Inability to receive thumb-tack needle treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- First Affiliated Hospital of Xiamen University — Xiamen
- First Affiliated Hospital of Xiamen University — Xiamen
Identifiers
NCT: NCT06757023 · FirstAHXiamenU-YB-3