Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Phase
Not applicable
Started
2024-12-31
Last updated
2024-10-09
Condition(s) studied
Sleep Disorder
Investigational drug(s) / intervention(s)
AcupunctureSham-acupuncture stimulation
Acupuncture: Administer medication at each acupoint a total of three times: (1) the night before surgery, (2) the night of surgery, and (3) the first night after surgery. In the acupuncture group, the acupuncture and moxibustion successively acupunctured four points with a depth of 10-20mm. Select the specific depth based on the subject\'s body type (tall, short, fat, thin). After the puncture, the acupuncture and moxibustion lifted and twisted the needle handle, and then retained the needle for 20 minutes.
Sham-acupuncture stimulation: The sham acupuncture group received non skin breaking comfort needles at the corresponding points for acupuncture and moxibustion and retained the needles for 20 minutes. Non transdermal comfort needles can cause patients to experience a needle like sensation similar to piercing the skin, but in reality, they do not break the skin.
Study summary
The goal of this clinical trial is to to explore the effect of perioperative transcutaneous acupoint acupuncture and moxibustion stimulation on sleep quality and postoperative chronic pain in patients undergoing thoracoscopic assisted radical resection of lung cancer, and explore its potential mechanism. This clinical trial focus on the following questions:
Whether perioperative transcutaneous acupoint acupuncture and moxibustion stimulation reduce the incidence of Postoperative Sleep Disorder and postoperative acute and chronic pain ? What medical problems do participants have when taking acupuncture? Researchers will compare acupuncture to sham acupuncture (Non transdermal comfort needles can cause patients to experience a needle like sensation; similar to when the needle is inserted into the skin, but in reality, it does not break the skin) to see if acupuncture works to reduce the incidence of Postoperative Sleep Disorder and postoperative acute and chronic pain.
Participants will:
Take acupuncture or a sham acupuncture every day for 3 days(the night before surgery, the night of surgery and the first night after surgery).
On the day before surgery, the first day after surgery, the second day after surgery, and the day before discharge, the sleep status should be continuously monitored using a sleep monitoring screening device (ZG-S01D) The incidence of pain is determined by whether there is pain (including all discomfort) during patient follow-up.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
\- Case selection: Patients undergoing elective thoracoscopic assisted radical resection for lung cancer, ASA grade I-II, aged 18-75 years.
Inclusion criteria:
1. Hospitalized patients aged ≥ 18 years old;
2. The surgical method is non emergency thoracoscopic assisted radical resection of lung cancer;
3. Patients with normal mental state, able to understand NRS scores, and correctly assess the degree of pain;
4. Patients who are informed and agree to the research objectives as explained.
5. Body Mass Index (BMI) 18.5-28 kg/m2
6. Preoperative clinical tumor lymph node metastasis (TNM) staging: according to cTis-3N01M0 of AJCC/UICC 8th edition.
Exclusion Criteria:
1. Patients with critical preoperative conditions or inability to cooperate;
2. Patients with postoperative disease recurrence, chronic infection, reoperation, or death;
3. Patients with severe complications, critical illness, or inability to cooperate after surgery;
4. Pittsburgh Sleep Quality Index (PSQI) score ≥ 7 or Insomnia Diagnosis - Ashens Insomnia Scale (AIS) score ≥ 6;
5. Sleep apnea or moderate or severe snoring;
6. In situ pacemaker, preoperative sinus bradycardia (heart rate ≤ 50 beats/minute) or sinoatrial node disease, second or third degree atrioventricular block
7. Long term use of anticonvulsants, antidepressants, or other psychotropic drugs
8. Severely sensitive or allergic to the drugs or devices in this study
9. Severe heart, liver, or kidney disease;
10. Participated in other clinical trials within the past 3 months;
h) Listening and/or language communication barriers; i) Pregnancy or breastfeeding; j) Clinical (hematological, radiological, and/or microbiological) evidence of fever (body temperature 38.5 ℃) or preoperative infection.
Primary outcome measure(s)
The incidence of Postoperative Sleep Disorders as Assessed by sleep monitoring screening device (ZG-S01D) and The The Athens Insomnia Scale — From enrollment to the end of treatment at 1 week; The Athens Insomnia Scale (AIS) is a self-assessment scale designed based on the ICD-10 diagnostic criteria for insomnia. There are a total of 8 questions, with the first 5 questions evaluating nighttime sleep and the last 3 questions evaluating daytime function. The scoring range for each question is 0-3, with a total score of 24 points. A score greater than or equal to 6 indicates the presence of sleep disorders. AIS is suitable for evaluating sleep status in the past month.
Trial sites (1)
Facility
City
Region
Status
Shanghai General Hospital
Shanghai
Shanghai Municipality
More Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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