Transcutaneous acupoint electrical stimulation improve depression after video-assisted thoracoscopic surgery: A randomized controlled study

注册号:

Registration number:

ITMCTR2024000839

最近更新日期:

Date of Last Refreshed on:

2024-12-18

注册时间:

Date of Registration:

2024-12-18

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

经皮穴位电刺激改善胸腔镜术后抑郁的随机对照研究

Public title:

Transcutaneous acupoint electrical stimulation improve depression after video-assisted thoracoscopic surgery: A randomized controlled study

注册题目简写:

TAES与VATS术后抑郁

English Acronym:

TAES and VATS postoperative depression

研究课题的正式科学名称:

经皮穴位电刺激改善胸腔镜术后抑郁的随机对照研究

Scientific title:

Transcutaneous acupoint electrical stimulation improve depression after video-assisted thoracoscopic surgery: A randomized controlled study

研究课题的正式科学名称简写:

TAES 改善 VATS术后抑郁

Scientific title acronym:

TAES improve VATS postoperative depression

研究课题代号(代码):

Study subject ID:

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

申请注册联系人:

张峻华

研究负责人:

张峻华

Applicant:

Junhua Zhang

Study leader:

Junhua Zhang

申请注册联系人电话:

Applicant telephone:

15213680591

研究负责人电话:

Study leader's telephone:

15213680591

申请注册联系人传真 :

Applicant Fax:

研究负责人传真:

Study leader's fax:

申请注册联系人电子邮件:

Applicant E-mail:

272073444@qq.com

研究负责人电子邮件:

Study leader's E-mail:

272073444@qq.com

申请单位网址(自愿提供):

Study leader's website(voluntary supply):

研究负责人网址(自愿提供):

Study leader's website
(voluntary supply):

申请注册联系人通讯地址:

重庆市涪陵区泽胜温泉城17栋1单元5-1

研究负责人通讯地址:

重庆市涪陵区泽胜温泉城17栋1单元5-1

Applicant address:

5-1, Unit 1, Building 17, Hot Spring City, Zesheng, Fuling, Chongqing

Study leader's address:

5-1, Unit 1, Building 17, Hot Spring City, Zesheng, Fuling, Chongqing

申请注册联系人邮政编码:

Applicant postcode:

408000

研究负责人邮政编码:

Study leader's postcode:

408000

申请人所在单位:

重庆大学附属涪陵医院

Applicant's institution:

Fuling Hospital Affiliated to Chongqing University

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2024CDFSFLYYEC-060

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

重庆大学附属涪陵医院伦理委员会

Name of the ethic committee:

Ethics Committee of Fuling Hospital Affiliated to Chongqing University

伦理委员会批准日期:

Date of approved by ethic committee:

2024/7/17 0:00:00

伦理委员会联系人:

李严

Contact Name of the ethic committee:

Yan Li

伦理委员会联系地址:

重庆市涪陵区高笋塘路2号

Contact Address of the ethic committee:

2 Gaotutang Road, Fuling District, Chongqing, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

023-72226537

伦理委员会联系人邮箱:

Contact email of the ethic committee:

381458717@qq.com

研究实施负责(组长)单位:

重庆大学附属涪陵医院

Primary sponsor:

ChongQing University Fuling Hospital

研究实施负责(组长)单位地址:

重庆市涪陵区高笋塘路2号

Primary sponsor's address:

2 Gaotutang Road, Fuling District, Chongqing, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆

市(区县):

涪陵

Country:

China

Province:

Chong Qing

City:

Fuling

单位(医院):

重庆大学附属涪陵医院

具体地址:

重庆市涪陵区高笋塘路2号

Institution
hospital:

ChongQing University Fuling Hospital

Address:

2 Gaotutang Road, Fuling District, Chongqing, China

经费或物资来源:

涪陵区科卫联合医学科研项目(项目编号:2022KWLH002)

Source(s) of funding:

Science-health joint medical research project in Fuling district.(Project Number:2022KWLH002)

研究疾病:

电视辅助胸腔镜术后抑郁

研究疾病代码:

Target disease:

video-assisted thoracoscopic surgery postoperative Depression

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

其它

Others

研究目的:

探索经皮穴位电刺激改善电视辅助胸腔镜术后抑郁状态的有效性和安全性。

Objectives of Study:

To explore the efficacy and safety of transcutaneous acupoint electrical stimulation in improving video-assisted thoracoscopic surgery postoperative depression.

药物成份或治疗方案详述:

定位双侧神门、内关、合谷、尺泽及安眠位。神门穴位于腕横纹尺侧端,尺侧腕屈肌腱的桡侧凹陷处。内关穴位于腕横纹上2寸,掌长肌腱与桡侧腕屈肌腱之间。合谷穴位于在手背第1、2掌骨间,当第二掌骨桡侧的中点处。安眠穴在耳后顶部,位于翳风穴与风池穴连线的中点。尺泽穴位于肘前侧,肘横纹上,肱二头肌腱桡侧缘凹陷中。患者入手术室后用75%乙醇擦拭穴位皮肤,待乙醇挥发干后放置电极片(50×50 mm)并固定。麻醉前30分钟连接TAES刺激器,设置频率2/10HZ和疏密波模式,根据患者最大耐受程度和肌肉颤搐设置电流强度,持续刺激至术毕。

Description for medicine or protocol of treatment in detail:

Locate the two sides of Shenmen Neiguan Hegu Chize and Anmian acupoint.The Shenmen acupoint is located at the ulnar end of the wrist stripe and the radial depression of the flexor tendon of the ulnar wrist.Neiguan acupoint is 2 cun above the wrist stripe between the long tendon of the palm and the flexor tendon of the wrist of the radial side.Hegu acupoint is located in the back of the hand between the first and second metacarpal bones when the second metacarpal bone radialis midpoint.The Anshen acupoint is at the top of the back of the ear located at the midpoint of the connection between Yifeng and Fengchi.The Chize acupoint is located in the anterior side of the elbow on the transverse line of the elbow and in the depression of the radial margin of the biceps tendon.After the patient entered the operating room the acupoint skin was wiped with 75% ethanol and the electrode sheet (50×50mm) was placed and fixed after the ethanol evaporated.The TAES stimulator was connected 30 minutes before anesthesia the frequency was set at 2/10HZ and the density-wave mode was set and the stimulation was continued until the end of the operation according to the patient's maximum tolerance and muscle twitch setting current intensity.

纳入标准:

18-65岁; 因肺部结节拟在全身麻醉下行择期单侧VATS术患者; ASA II-III级; 患者意识清楚正常,无表达障碍,有能力配合治疗并签署知情同意书

Inclusion criteria

Age 18-65 Patients undergoing unilateral VATS surgery due to pulmonary nodules under general anesthesia ASA II-III stage The patient is conscious and normal, has no expression disorder, and is capable of cooperating with treatment and signing informed consent

排除标准:

合并穴位局部皮肤感染者; 合并上肢神经损伤者; 体内植入起搏器者; 酗酒及长期服用阿片类药物、激素类药物及抗炎镇痛药物者; 对试验中所用药物过敏者; ⑹.近期进行过TAES或穴位理疗者; 精神病史或正在使用精神类药品治疗者; 正在接受单胺氧化酶(MAO)抑制剂治疗者; 合并有严重心、脑、肝、肾以及造血系统等方面疾病者; 任何原因不能配合研究的患者

Exclusion criteria:

Combined with acupoint local skin infection Patients with upper extremity nerve injury Patients with an implanted pacemaker Alcoholics and long-term users of opioids, hormones, anti-inflammatory and analgesic drugs Allergic to the drug used in the trial Have recently undergone TAES or acupoint therapy A history of mental illness or ongoing use of psychotropic drugs People being treated with monoamine oxidase (MAO) inhibitors Patients with severe diseases of heart, brain, liver, kidney and hematopoietic system Patients who were unable to cooperate with the study for any reason

研究实施时间:

Study execute time:

From 2024-11-01

To      2027-11-01

征募观察对象时间:

Recruiting time:

From 2024-12-20

To      2026-01-01

干预措施:

Interventions:

组别:

T组

样本量:

60

Group:

Group T

Sample size:

干预措施:

麻醉诱导前30分钟开始穴位刺激,持续至术毕

干预措施代码:

Intervention:

Acupoint stimulation began 30 minutes before anesthesia induction and continued until the end of the operation

Intervention code:

组别:

C组

样本量:

60

Group:

Group C

Sample size:

干预措施:

麻醉诱导前30分钟开始假穴位刺激,假穴位位于各个穴位内侧4cm,持续至术毕

干预措施代码:

Intervention:

Sham-acupoint stimulation began 30 minutes before anesthesia induction , the Sham-acupoint was located 4cm inside the each acupoint, continued until the end of the operation

Intervention code:

样本总量 Total sample size : 120

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

重庆

市(区县):

Country:

China

Province:

Chong Qing

City:

Fu Ling

单位(医院):

重庆大学附属涪陵医院

单位级别:

三级甲等医院

Institution/hospital:

Chongqing University Fuling Hospital

Level of the institution:

the third-class a hospita

测量指标:

Outcomes:

指标中文名:

术后2天睡眠NRS评分

指标类型:

次要指标

Outcome:

Sleep NRS score 2 days after surgery

Type:

Secondary indicator

测量时间点:

术后2天

测量方法:

数字评分法(NRS,0表示无法入睡,10表示睡眠很好)

Measure time point of outcome:

2 days after surgery

Measure method:

numerical rating scale score (0 means unable to sleep 10 means sleep well)

指标中文名:

术后48h镇痛泵用量

指标类型:

次要指标

Outcome:

Dosage of patient-controlled intravenous analgesia 48h after operation

Type:

Secondary indicator

测量时间点:

术后48h

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后24h患者自控静脉镇痛用量

指标类型:

次要指标

Outcome:

Dosage of patient-controlled intravenous analgesia 24h after operation

Type:

Secondary indicator

测量时间点:

术后24小时

测量方法:

Measure time point of outcome:

24 hours postoperative

Measure method:

指标中文名:

术后2天贝克抑郁量表评分

指标类型:

次要指标

Outcome:

Beck depression inventory score 2 days after surgery

Type:

Secondary indicator

测量时间点:

术后2天

测量方法:

贝克抑郁量表评分

Measure time point of outcome:

2 days after surgery

Measure method:

Beck depression inventory score

指标中文名:

术后2天血清肿瘤坏死因子-α浓度

指标类型:

次要指标

Outcome:

Serum tumor necrosis factor-α concentration 2 days after surgery

Type:

Secondary indicator

测量时间点:

术后2天

测量方法:

酶联免疫吸附试验

Measure time point of outcome:

2 days after surgery

Measure method:

enzyme linked immunosorbent assay

指标中文名:

术后2天血清白介素-6浓度

指标类型:

次要指标

Outcome:

Serum interleukin-6 concentration 2 days after surgery

Type:

Secondary indicator

测量时间点:

术后2天

测量方法:

酶联免疫吸附试验

Measure time point of outcome:

2 days after surgery

Measure method:

enzyme linked immunosorbent assay

指标中文名:

术后30天贝克抑郁量表评分

指标类型:

主要指标

Outcome:

Beck depression inventory score 30 days after surgery

Type:

Primary indicator

测量时间点:

术后30天

测量方法:

贝克抑郁量表评分

Measure time point of outcome:

30 days after surgery

Measure method:

Beck depression inventory score

指标中文名:

术后24h静息痛评分

指标类型:

次要指标

Outcome:

24h postoperative resting pain score

Type:

Secondary indicator

测量时间点:

术后24h

测量方法:

数字评分法(NRS,0表示无痛,10表示剧烈痛)

Measure time point of outcome:

24 hours postoperative

Measure method:

numerical rating scale score (0 means no pain 10 means worst pain)

指标中文名:

术后48h活动痛评分

指标类型:

次要指标

Outcome:

48h postoperative moving pain score

Type:

Secondary indicator

测量时间点:

术后48小时

测量方法:

数字评分法(NRS,0表示无痛,10表示剧烈痛)

Measure time point of outcome:

48 hours postoperative

Measure method:

numerical rating scale score (0 means no pain 10 means worst pain)

指标中文名:

术后48h静息痛评分

指标类型:

次要指标

Outcome:

48h postoperative resting pain score

Type:

Secondary indicator

测量时间点:

术后48h

测量方法:

数字评分法(NRS,0表示无痛,10表示剧烈痛)

Measure time point of outcome:

48 hours postoperative

Measure method:

numerical rating scale score (0 means no pain 10 means worst pain)

指标中文名:

TAES相关并发症

指标类型:

次要指标

Outcome:

TAES Related complications

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后24h活动痛评分

指标类型:

次要指标

Outcome:

24h postoperative moving pain score

Type:

Secondary indicator

测量时间点:

术后24h

测量方法:

数字评分法(NRS,0表示无痛,10表示剧烈痛)

Measure time point of outcome:

24 hours postoperative

Measure method:

numerical rating scale score (0 means no pain 10 means worst pain)

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 65
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

由与本试验执行数据管理统计分析无关的生物统计学家在计算机上用SPSS V.22.0软件产生随机数字;

Randomization Procedure (please state who generates the random number sequence and by what method):

Random numbers are generated on the computer by SPSSV.22.0 software by biostatisticians who are not related to the statistical analysis of data management performed in this experiment .

盲法:

由临床麻醉医生负责术中麻醉管理及数据记录; 由经过培训的研究人员负责术前术后评估和数据采集; 麻醉医师与围术期评估人员均不知晓患者随机分组情况; 对患者施盲:TAES组术前术后根据患者最大耐受程度和肌肉颤动设置电流,假-TAES组将电极片贴在穴位内侧约4cm位置,给予与TAES组相同方法的频率电流设置让患者认为接受了TAES治疗。因此所有患者均对随机分组情况不知晓。

Blinding:

The clinical anesthesiologist is responsible for intraoperative anesthesia management and data recording; Preoperative and postoperative assessment and data collection by trained researchers; Neither anesthesiologists nor perioperative evaluators knew the randomization of patients; Patients were blinded: in the TAES group the current was set before and after surgery according to the patient's maximum tolerance and muscle fibrillation. In the pseudo-TAES group the electrode was affixed to the inner position of the acupoint about 4cm and the frequency current setting was given in the same way as in the TAES group to make the patients think that they had received TAES treatment. Therefore all patients were unaware of the randomization

是否共享原始数据:

IPD sharing:

No

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

本次研究的原始数据可通过电子邮件向研究团队提出合理要求

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The individual participant data for this study is available from the sponsor on reasonable request through email

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

研究者根据受试者的原始观察记录,将数据及时、完整、正确的载入病例报告表; 病例报告表在按要求完成数据录入和核查后,按编号的顺序归档保存

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

According to the original observation records of the subjects the researcher will timely complete and correct data into the case report form; The case report form shall be archived in numbered order after data entry and verification as requir

数据管理委员会:

Data Managemen Committee:

No

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above