ChiCTR2600126079 版本V1.0 版本创建时间2026/06/03 14:35:22 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600126079 

最近更新日期：

Date of Last Refreshed on：

 2026-06-03 14:35:15 

注册时间：

Date of Registration：

 2026-06-03 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

揿针联合宫调式音乐疗法对甲状腺癌术后 PONV 疗效影响的临床研究

Public title：

Clinical Study on the Efficacy of Pressing Needle Combined with Palace Mode Music Therapy in Postoperative Nausea and Vomiting (PONV) after Thyroid Cancer Surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

揿针联合宫调式音乐疗法对甲状腺癌术后 PONV 疗效影响的临床研究

Scientific title：

Clinical Study on the Efficacy of Pressing Needle Combined with Palace Mode Music Therapy in Postoperative Nausea and Vomiting (PONV) after Thyroid Cancer Surgery

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：

何为 

研究负责人：

何为 

Applicant：

He Wei 

Study leader：

He Wei 

申请注册联系人电话：

Applicant telephone：

 +86 135 2780 5056

研究负责人电话：

Study leader's
telephone：

+86 135 2780 5056

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：

 heweijiangxi@163.com

研究负责人电子邮件：

Study leader's E-mail：

 heweijiangxi@163.com

申请单位网址(自愿提供)：

Applicant 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：

中国广东省广州市番禺区大学城内环西路55号

研究负责人通讯地址：

中国广东省广州市番禺区大学城内环西路55号

Applicant address：

55 Neihuan West Road, University Town, Panyu District, Guangzhou, Guangdong, China

Study leader's address：

55 Neihuan West Road, University Town, Panyu District, Guangzhou, Guangdong, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

广州中医药大学第二附属医院

Applicant's institution：

Guangzhou University of Chinese Medicine Second Affiliated Hospital

研究负责人所在单位：

广州中医药大学第二附属医院

Affiliation of the Leader：

Guangzhou University of Chinese Medicine Second Affiliated Hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 广东省中医院伦理委员会BF2025-105-01

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

广东省中医院伦理委员会

Name of the ethic committee：

Guangdong Provincial Hospital of Chinese Medicine Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-05-09 00:00:00

伦理委员会联系人：

李晓彦

Contact Name of the ethic committee：

Li Xiaoyan

伦理委员会联系地址：

中国广东省广州市越秀区大德路111号

Contact Address of the ethic committee：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 8188 7233

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

广州中医药大学第二附属医院

Primary sponsor：

Guangzhou University of Chinese Medicine Second Affiliated Hospital

研究实施负责（组长）单位地址：

中国广东省广州市番禺区大学城内环西路55号

Primary sponsor's address：

55 Neihuan West Road, University Town, Panyu District, Guangzhou, Guangdong, 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)：

广东

市(区县)：

广州

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

广州中医药大学第二附属医院

具体地址：

中国广东省广州市越秀区大德路111号

Institution
hospital：

Guangzhou University of Chinese Medicine Second Affiliated Hospital

Address：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

经费或物资来源：

广东省中医药局

Source(s) of funding：

Guangdong Provincial Administration of Traditional Chinese Medicine

研究疾病：

甲状腺癌  

Target disease：

Thyroid Cancer

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

甲状腺癌是最常见的内分泌系统恶性肿瘤，也是我国发病率增长最快的恶性肿瘤，手术治疗仍是治疗的基石，PONV在甲状腺癌术后患者发生率较高，可带来严重后果，因此在甲状腺癌术后患者进行预防及治疗PONV具有重要意义。本研究从中医角度入手，创新性提出揿针联合宫调式音乐疗法治疗PONV，为其在甲状腺癌PONV的预防及治疗的联合应用提供有力证据。揿针和五音疗法对PONV有一定的疗效，但临床上鲜有对二者中医外治疗法的研究或报道。因此，本研究采用前瞻性、随机对照研究的方法，通过问卷调查获取治疗后对照组、实验1组、实验2组患者PONV的NVAS评分，采用组间对比研究，统计不同治疗组之间的数据差异，客观评价揿针联合宫调式音乐疗法对甲状腺癌PONV的临床疗效，寻求预防甲状腺癌术后最优中医适宜技术。  

Objectives of Study：

Thyroid cancer is the most common malignant tumor of the endocrine system and the malignant tumor with the fastest increasing incidence rate in China. Surgical treatment remains the cornerstone of therapy. Postoperative nausea and vomiting (PONV) occurs at a high frequency in thyroid cancer patients after surgery, which can lead to serious consequences. Therefore, the prevention and treatment of PONV in postoperative thyroid cancer patients hold significant importance. This study approaches from the perspective of traditional Chinese medicine (TCM), innovatively proposing the combined therapy of (pressing needle) and palatial mode music therapy for PONV, aiming to provide robust evidence for their combined application in the prevention and treatment of PONV in thyroid cancer patients. While pressing needles and the five-tone therapy have demonstrated certain efficacy against PONV, there are few clinical studies or reports on the combined external TCM therapies. Thus, this study adopts a prospective, randomized controlled study design, collecting the NVAS scores of PONV in the control group, experimental group 1, and experimental group 2 through questionnaires, conducting intergroup comparisons to statistically analyze the data differences among the treatment groups. This objectively evaluates the clinical efficacy of the combined pressing needle and palatial mode music therapy for PONV in thyroid cancer patients, seeking the optimal TCM-appropriate technique for preventing postoperative PONV in thyroid cancer.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 甲状腺癌诊断标准参照《甲状腺疾病相关中医病名考辨》、《甲状腺癌诊疗规范(2018年版)》； 2. 行甲状腺癌切除术； 3. 年龄18岁<=年龄<=65岁，性别不限； 4. 意识清晰，理解能力可，可清晰完整表达者； 5. 患者知情同意，且自愿参与本研究； 6. 未参加其他研究项目者。

Inclusion criteria

1. Diagnostic criteria referred to "Discussion on TCM Disease Names Related to Thyroid Diseases" and "Diagnosis and Treatment Guidelines for Thyroid Cancer (2018 Edition);" 2. Underwent thyroid cancer resection surgery; 3. Age between 18 and 65 years, gender unrestricted; 4. Mentally alert, with adequate comprehension ability, and capable of clear and complete expression; 5. Provided informed consent and voluntarily participated in the study; 6. Not participated in other research projects.

排除标准：

1. 合并心、肺、脑、肾等严重疾病者； 2. 有严重感染、呼吸功能不全、凝血功能障碍、严重肝、肾功能不全； 3. 糖尿病合并代谢性并发症患者； 4. 存在恶心呕吐障碍或感觉异常患者； 5. 术前24h内应用过止呕药物； 6. 麻醉方式为非全麻； 7. 存在皮肤损伤或过敏、针头晕厥史患者； 8. 无法配合治疗及调查者，如有精神疾病史、脑血管意外后遗症患者。

Exclusion criteria：

1. Patients with severe systemic diseases such as heart, lung, brain, or kidney disorders; 2. Severe infection, respiratory insufficiency, coagulation dysfunction, severe hepatic or renal insufficiency, or diabetes mellitus with metabolic complications; 3. Patients with nausea and vomiting disorders or sensory abnormalities; 4. Patients who had received antiemetic drugs within 24 hours preoperatively; 5. Patients undergoing non-general anesthesia; 6. Patients with skin injury or allergy, or a history of syncope/dizziness after acupuncture; 7. Patients unable to cooperate with treatment and investigation, such as those with a history of mental illness or post-stroke sequelae.

研究实施时间：

Study execute time：

从 From 2025-05-01 00:00:00至 To 2026-07-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-25 00:00:00 至 To 2026-07-01 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 43

Group：

Control Group

Sample size：

干预措施：

1. 指导患者术前进行颈仰卧位训练，深呼吸，去枕平卧，后颈和肩部垫一20cm左右长枕，术前1d进行锻炼，2～3次/d，10～30min/次。对存在颈椎病等疾患者则低枕短时间训练； 2. 营造良好病房环境，保持舒适环境，光线柔和，空气清新无异味。术后回病房细情接待患者，主动关心患者，鼓励放松精神，心理护理，安慰情绪紧张、焦虑患者, 调整不良心理状态，消除不良情绪； 3. 麻醉清醒前去枕平卧，保持呼吸道通畅，并持续低流量给氧。术后6h如无不适，床边协助患者饮白开水20～30ml，观察有无恶心呕吐不适感，嘱清淡、温凉易消化流质或半流质饮食，忌甜、油腻等刺激性食物； 4. 患者术后回病房后立即给予耳穴压豆治疗。取穴：胃、交感、神门、皮质下。将王不留行籽粘贴于相应穴位，给予适度压、捏、按，以产生胀、酸、热、痛、麻“得气”感为佳，持续1～2min。当患者出现恶心呕吐不适时，协助患者及家属额外加压刺激耳穴贴压的穴位。此后按压1次/4 h，双耳间歇按压，保留3d； 5. 对出现恶心呕吐患者，协助家属用手轻压伤口减少颈部损伤，观察呕吐物色、质、量，配合医生，遵医嘱控制和预防激烈呕吐, 及时清除呕吐物。

干预措施代码：

Intervention：

1. Preoperative Neck Position Training Guide patients to practice supine neck extension position (lying flat without a pillow, placing a 20cm-long pillow under the back of the neck and shoulders). Train 2–3 times/day for 10–30 minutes/day, starting 1 day before surgery. For patients with cervical spondylosis or other cervical diseases, use a low pillow and shorten the training duration. 2. Ward Environment and Psychological Care Create a comfortable ward environment with soft lighting, fresh air, and no unpleasant odors. Upon returning to the ward post-surgery, warmly receive patients, actively show concern, encourage emotional relaxation, and provide psychological support. Comfort patients with anxiety or tension, adjust negative psychological states, and eliminate adverse emotions. 3. Postoperative Physiological Management Maintain supine position without a pillow until the patient regains consciousness from anesthesia, ensuring airway patency and continuous low-flow oxygen supply. 6 hours post-surgery, if no discomfort is observed, assist the patient in drinking 20–30ml of plain water at the bedside, monitoring for nausea or vomiting. Advise a light, cool, easily digestible liquid or semi-liquid diet, avoiding sweet, greasy, or stimulating foods. 4. Auricular Acupressure Therapy Immediately after returning to the ward post-surgery, apply auricular acupressure with Vaccaria seeds. Selected acupoints: Stomach (), Sympathetic (), Shenmen (), Hypothalamus (). Attach Vaccaria seeds to the corresponding acupoints and apply moderate pressure, pinching, or pressing until a "deqi" sensation (heaviness, soreness, heat, pain, or numbness) is achieved, lasting 1–2 minutes. If nausea/vomiting occurs, assist the patient and family in additional stimulation of the acupressure points. Press the points once every 4 hours, alternating between both ears, and retain the seeds for 3 days. 5. Management of Nausea/Vomiting For patients experiencing nausea/vomiting, assist family members in gently pressing the wound area to reduce neck trauma. Observe the color, consistency, and volume of vomitus. Cooperate with physicians and follow medical instructions to control and prevent severe vomiting, promptly clearing vomitus.

Intervention code：

组别：

实验一组

样本量：

 43

Group：

Experimental Group 1

Sample size：

干预措施：

基础治疗+揿针留针双侧内关、足三里24h

干预措施代码：

Intervention：

Basic treatment combined with retained acupressure needles at bilateral Neiguan (PC6) and Zusanli (ST36) for 24 hours.

Intervention code：

组别：

实验二组

样本量：

 43

Group：

Experimental Group 2

Sample size：

干预措施：

基础治疗+揿针留针双侧内关、足三里24h＋宫调式音乐

干预措施代码：

Intervention：

Basic treatment combined with retained acupressure needles at bilateral Neiguan (PC6) and Zusanli (ST36) for 24 hours, plus Gong mode music.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

 广州 

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

 广州中医药大学第二附属医院 

单位级别：

 三甲 

Institution
hospital：

Guangzhou University of Chinese Medicine Second Affiliated Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

视觉模拟评分法（NVAS）

指标类型：

主要指标

Outcome：

Numerical Visual Analog Scale (NVAS)

Type：

Primary indicator

测量时间点：

干预前、干预后及术后 6h、24h、48h

测量方法：

Measure time point of outcome：

Before intervention, after intervention, and 6h, 24h, 48h postoperatively

Measure method：

指标中文名：

恶心呕吐发生例数和恶心呕吐发生率

指标类型：

次要指标

Outcome：

Incidence of Nausea and Vomiting (Number and Rate)

Type：

Secondary indicator

测量时间点：

术后 0～6h、6～24h、24～48h

测量方法：

Measure time point of outcome：

0–6h, 6–24h, 24–48h postoperatively

Measure method：

指标中文名：

术后并发症

指标类型：

次要指标

Outcome：

Postoperative 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：

住院时间

指标类型：

次要指标

Outcome：

Length of Hospital Stay

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

住院满意度

指标类型：

次要指标

Outcome：

Inpatient Satisfaction Score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

SF-36 生活质量评分量表

指标类型：

次要指标

Outcome：

SF-36 Quality of Life Score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

安全性指标（包括：生命体征、不良事件、严重不良事件）

指标类型：

副作用指标

Outcome：

Safety Outcomes (including Vital Signs, Adverse Events, Serious Adverse Events)

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

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：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

采用随机对照研究设计方案，将纳入对象按术后先后顺序对应事先做好的随机信封序号拆封取卡，将合格研究对象随机分为对照组和实验1组，实验2组。

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

A randomized controlled study design was adopted. The included subjects were opened and the cards were taken from the pre-prepared random envelopes in the order of postoperative sequence. The qualified research subjects were randomly divided into the control group, experimental group 1 and experimental group 2.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

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）：

研究结束后半年；国家生物信息中心(https://www.cncb.ac.cn/)

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

Six months after the completion of the research; China National Center for Bioinformation (https://www.cncb.ac.cn/)

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：

病例记录表

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

Case Record Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-06-03 14:35:15