Actively Recruiting

Age: 18Years - 55Years
All Genders
ID06757023

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

Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-01-03

110

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand how thumb-tack needle therapy affects sleep and recovery after surgery in patients who have undergone general anesthesia for breast cancer surgery. The study focuses on improving postoperative sleep quality, preventing sleep disorders, and promoting recovery following surgery. Participants are women aged 18 to 55 years with no history of chronic insomnia or recent use of sedative-hypnotic drugs. Participants in this observational study will undergo thumb-tack needle therapy as part of their postoperative care. The therapy's impact will be monitored without assigning different treatment groups. The study will follow patients before and after anesthesia exposure to observe changes in sleep quality and recovery. During the study, researchers will assess sleep quality using the Pittsburgh Sleep Quality Index (PSQI) one or two days before anesthesia and on days 1, 3, and 7 after anesthesia. Recovery will also be evaluated with the QoR-40 questionnaire on the third day after surgery. The study monitors patient progress to explore the clinical significance of thumb-tack needle therapy in improving postoperative outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing breast cancer surgery with general anesthesia in the hospital
  • American Society of Anesthesiologists (ASA) classification I-II
  • Women aged 18 to 55 years
  • No history of chronic insomnia
  • No use of sedative-hypnotic drugs within the past month
Not Eligible

You will not qualify if you...

  • Not meeting the inclusion criteria
  • History of severe heart, brain, lung, or kidney diseases such as acute coronary syndrome, severe heart failure (NYHA Class III or IV), severe arrhythmias, severe valvular disease, acute aortic disease, or severe peripheral vascular disease
  • Poor physical condition including reduced exercise tolerance, multi-organ dysfunction, or malnutrition
  • History of sleep disorders or psychiatric illness
  • Inability to receive thumb-tack needle treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo breast cancer surgery with general anesthesia in the hospital and receive immediate post-operative care.

1 visit (in-person)

Post-operative Follow-up

Duration - 7 days

Participants complete assessments of sleep quality and recovery after surgery using questionnaires.

3 visits (in-person) on days 1, 3, and 7 after anesthesia exposure

Trial Site Locations

Total: 2 locations

1

First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China, 361000

Actively Recruiting

2

First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China, 361000

Actively Recruiting

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Research Team

B

Bin Yang doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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