Postoperative Sleep Quality and Pain of Patients After Video-Assisted Thoracoscopic Surgery

NCT06633432 | Not Yet Recruiting DMC

• 1 other identifier: Yuan Lun Shen 【2024】No.164
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Disorder

Outcome Measures

Primary Outcomes (1)

• The incidence of Postoperative Sleep Disorders as Assessed by sleep monitoring screening device (ZG-S01D) and The The Athens Insomnia Scale

  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.

  From enrollment to the end of treatment at 1 week;

Study Arms (2)

Acupuncture group

EXPERIMENTAL

The acupuncture group administered medication three times at each acupoint: (1) the night before surgery, (2) the night of surgery, and (3) the first night after surgery. Acupuncture and moxibustion stimulation was applied to four pairs of acupoints: bilateral Shenmen (HT7), Neiguan (PC6), Zusanli (ST36) and Zhaohai (KI6), and the penetration depth was 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.

Other: Acupuncture

Sham-acupuncture group

SHAM COMPARATOR

The sham acupuncture group received non skin breaking comfort needles at corresponding points for acupuncture and moxibustion the night before the operation, the night of the operation and the first night after the operation, and kept 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.

Other: Sham-acupuncture stimulation

Interventions

Acupuncture OTHER

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.

Acupuncture group

Sham-acupuncture stimulation OTHER

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.

Also known as: sham acupuncture

Sham-acupuncture group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Case selection: Patients undergoing elective thoracoscopic assisted radical resection for lung cancer, ASA grade I-II, aged 18-75 years.
• Hospitalized patients aged ≥ 18 years old;
• The surgical method is non emergency thoracoscopic assisted radical resection of lung cancer;
• Patients with normal mental state, able to understand NRS scores, and correctly assess the degree of pain;
• Patients who are informed and agree to the research objectives as explained.
• Body Mass Index (BMI) 18.5-28 kg/m2
• Preoperative clinical tumor lymph node metastasis (TNM) staging: according to cTis-3N01M0 of AJCC/UICC 8th edition.

You may not qualify if:

• Patients with critical preoperative conditions or inability to cooperate;
• Patients with postoperative disease recurrence, chronic infection, reoperation, or death;
• Patients with severe complications, critical illness, or inability to cooperate after surgery;
• Pittsburgh Sleep Quality Index (PSQI) score ≥ 7 or Insomnia Diagnosis - Ashens Insomnia Scale (AIS) score ≥ 6;
• Sleep apnea or moderate or severe snoring;
• In situ pacemaker, preoperative sinus bradycardia (heart rate ≤ 50 beats/minute) or sinoatrial node disease, second or third degree atrioventricular block
• Long term use of anticonvulsants, antidepressants, or other psychotropic drugs
• Severely sensitive or allergic to the drugs or devices in this study
• Severe heart, liver, or kidney disease;
• 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.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 201600, China

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Shanghai 1st

  Xueying Ding

  STUDY DIRECTOR

Central Study Contacts

Lina Huang N Huang

CONTACT

86-021-63240090; shiyicss@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Using SPSS 25.0 software, random numbers from 001 to 316 were generated through a computer and randomly assigned in a 1:1 ratio to either the acupuncture group or the sham acupuncture group. The group information is sealed in opaque envelopes numbered randomly. Qualified subjects will be randomly assigned numbers in descending order of enrollment, without skipping numbers. Before implementing acupuncture and moxibustion, the acupuncture and moxibustion shall open the envelope allocated with the corresponding random number of the subject and conduct acupuncture and moxibustion according to the grouping information in the envelope. However, there was no communication between the acupuncture and moxibustion and other researchers and study patients about this study. Patients, attending anesthesiologists, surgeons, and data collectors (doctors responsible for evaluating sleep variables in the sleep laboratory) are all unaware of group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician of Anesthesiology Department, Shanghai General Hospital

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 9, 2024
• Study Start: December 31, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)