中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600121435
最近更新日期： Date of Last Refreshed on：	2026-03-31 08:37:39
注册时间： Date of Registration：	2026-03-31 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	饮用冰水在改善开放性甲状腺全部切术后患者咽痛的应用研究
Public title：	Ice Water Intake Intervention for the Management of Throat Pain after Thyroid Cancer Surgery
注册题目简写：
English Acronym：
研究课题的正式科学名称：	饮用冰水在改善开放性甲状腺全部切术后患者咽痛的应用研究
Scientific title：	Ice Water Intake Intervention for the Management of Throat Pain 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：	罗佳	研究负责人：	李莎
Applicant：	Luo Jia	Study leader：	Li Sha
申请注册联系人电话： Applicant telephone：	+86 182 1340 0135	研究负责人电话： Study leader's telephone：	+86 137 0063 9109
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：	luojia@kmmu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	18213400135@163.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：	云南省肿瘤医院	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：	中国云南省昆明市西山区昆州路519号	研究负责人通讯地址：	中国云南省昆明市西山区昆州路519号
Applicant address：	519 Kunzhou Road, Xishan District, Kunming, Yunnan, China	Study leader's address：	519 Kunzhou Road, Xishan District, Kunming, Yunnan, China
申请注册联系人邮政编码： Applicant postcode：	650118	研究负责人邮政编码： Study leader's postcode：	650118
申请人所在单位：	云南省肿瘤医院
Applicant's institution：	Yunnan Cancer Hospital
研究负责人所在单位：	云南省肿瘤医院
Affiliation of the Leader：	Yunnan Cancer 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：	KYLX2024-097	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：	云南省肿瘤医院伦理委员会
Name of the ethic committee：	Ethics Committee of Yunnan Cancer Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-03-12 00:00:00
伦理委员会联系人：	许玉玲
Contact Name of the ethic committee：	Xu Yuling
伦理委员会联系地址：	中国云南省昆明市西山区昆州路519号
Contact Address of the ethic committee：	519 Kunzhou Road, Xishan District, Kunming, Yunnan, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 871 6817 9625	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：

云南省肿瘤医院

Primary sponsor：

Yunnan Cancer Hospital

研究实施负责（组长）单位地址：

中国云南省昆明市西山区昆州路519号

Primary sponsor's address：

519 Kunzhou Road, Xishan District, Kunming, Yunnan, 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)：	云南	市(区县)：	昆明
Country：	China	Province：	Yunnan	City：	Kunming
单位(医院)：	云南省肿瘤医院	具体地址：	中国云南省昆明市西山区昆州路519号
Institution hospital：	Yunnan Cancer Hospital	Address：	519 Kunzhou Road, Xishan District, Kunming, Yunnan, China

经费或物资来源：

云南省科研基金项目2024J0369

Source(s) of funding：

The Scientific Research Fund of Yunnan Provincial 2024J0369

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：

非随机对照试验

Study design：

Non randomized control

研究目的：

本研究通过回顾文献，了解开放性甲状腺手术患者术后咽痛的现状，拟定饮用冰水改善开放性甲状腺患者术后咽痛的干预方案，同时评价实施干预措施后患者术后咽痛的缓解程度及对患者短期生活质量的影响，以期为开放性甲状腺全部切除手术患者术后咽痛的管理提供参考依据。

Objectives of Study：

This study conducts a literature review to understand the current status of postoperative throat pain in patients undergoing open thyroid surgery. An intervention plan will be developed to improve postoperative throat pain in these patients through the consumption of iced water. Additionally, the study will assess the degree of relief from throat pain following the implementation of the intervention measures, as well as their impact on the patients' short-term quality of life, with the aim of providing a reference for the management of postoperative throat pain in patients undergoing total thyroidectomy.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

1. 患者作答呈明显规律性； 2. 患者不能耐受冷刺激易出现胃肠道不适症状； 3. 术后因并发症须再次手术的患者

Exclusion criteria：

1. Patients whose responses show a clear pattern; 2. Patients who cannot tolerate cold stimuli and are prone to gastrointestinal discomfort; 3. Patients requiring reoperation due to postoperative complications.

研究实施时间：

Study execute time：

从 From 2024-04-01 00:00:00至 To 2024-07-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-04-01 00:00:00 至 To 2024-07-31 00:00:00

干预措施：

Interventions：

组别：	对照组	样本量：	40
Group：	Control Group	Sample size：	40
干预措施：	一般性术后咽痛护理；术后6h可进温凉流食，2～3 d指导患者进食清淡，温凉的普食；疼痛护理以安慰患者为主，不做特殊性干预。	干预措施代码：
Intervention：	General postoperative sore throat care; soft, cool liquids allowed 6 hours postoperatively, and bland, cool regular diet guided over 2-3 days; pain management primarily involves reassurance without specific interventions.	Intervention code：

组别：	干预组	样本量：	40
Group：	Intervention Group	Sample size：	40
干预措施：	间断性饮用冰水干预；术后6h可进温凉流食，2～3 d指导患者进食清淡，温凉的普食；麻醉清醒后如出现咽喉痛症状，给予患者20-30ml冰水，分两次进行缓慢吞咽，麻醉清醒后每4-6h进行一次饮用冰水，直至术后48h。	干预措施代码：
Intervention：	Intermittent ice water drinking intervention; soft, cool liquids allowed 6 hours postoperatively, and bland, cool regular diet guided over 2-3 days; if sore throat occurs after anesthesia recovery, administer 20-30ml of ice water in two slow swallows, repeated every 4-6 hours until 48 hours postoperatively.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	昆明	市(区县)：	昆明
Country：	China	Province：	Yunnan	City：	Kunming
单位(医院)：	云南省肿瘤医院	单位级别：	三甲
Institution hospital：	Yunnan Cancer Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	术后咽痛程度	指标类型：	主要指标
Outcome：	Postoperative pharyngeal pain severity	Type：	Primary indicator
测量时间点：	术后6h、24h、48h、72h	测量方法：	Prince-Henry评分量表
Measure time point of outcome：	6 hours, 24 hours, 48 hours, 72 hours after surgery	Measure method：	Prince-Henry Pain Scale

指标中文名：	患者短期生活质量	指标类型：	主要指标
Outcome：	Short-term quality of life in patients	Type：	Primary indicator
测量时间点：	术后24h、72h	测量方法：	中文版甲状腺癌特异性生命质量量表(THYCA-QoL)
Measure time point of outcome：	24 hours, 72 hours after surgery	Measure method：	Chinese version of the Thyroid Cancer-specific Quality of Life Questionnaire (THYCA-QoL)

指标中文名：	安全性指标（包括：胃肠道不适症状）	指标类型：	副作用指标
Outcome：	Safety outcomes (including gastrointestinal discomfort symptoms)	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	其它	说明
Fate of sample：	0thers	Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	54	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）：

无

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

None

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）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	原始数据将在研究结束后 6 个月内，通过国家生物信息中心平台进行公开共享。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	The raw data will be publicly shared within 6 months after the completion of the study via the National Genomics Data Center (NGDC). Platform: National Genomics Data Center (NGDC) URL: https://ngdc.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：	数据采集采集对象：本研究入组的甲状腺癌手术患者，所有研究对象均签署知情同意书。采集人员：由 2 名经统一培训的专科护师完成数据采集，培训内容包括 Prince-Henry 咽痛评分量表、中文版甲状腺癌特异性生命质量量表的使用规范、评分标准统一、调查技巧及数据记录要求，培训后经考核合格方可参与采集工作。采集指标：1 患者基线资料，包括性别、年龄、肿瘤病理分型、肿瘤分期、手术方式、既往病史等；2 术后结局指标，包括返回病房后 24 h、72 h Prince-Henry 量表术后咽痛评分，返回病房后 24 h、72 h 中文版甲状腺癌特异性生命质量量表评分。采集方法与时间：患者返回病房后，严格按照预设时间节点（24 h、72 h），由采集人员采用统一纸质调查表进行一对一现场评估与数据记录，量表填写过程中对研究对象的疑问进行标准化解答，确保评分结果真实、准确，调查表当场核对无漏项、错项后确认归档。数据管理数据录入：采集完成的调查表由 2 名独立的研究人员采用 EpiData 3.1 软件进行双人双份独立录入，建立原始数据库，录入过程中严格遵循「一人录入、一人核对」原则，避免录入误差。数据质控：数据库建立后，通过软件逻辑校验功能排查异常值、缺失值及逻辑矛盾数据，对存疑数据及时与原始调查表核对，联系采集人员溯源核实并修正，缺失值采用合理方式补充（如电话随访），确保数据完整性与准确性；所有量表评分均进行一致性检验，保证评分结果可靠。数据存储与隐私保护：原始纸质调查表整理后密封归档，存放于科室专用资料柜；电子数据库进行加密处理（设置访问密码），存储于医院科室专用科研电脑，所有数据均进行患者信息脱敏处理，隐去姓名、住院号、身份证号等可识别隐私信息，仅以编号标识研究对象；原始数据与数据库均由专人保管，严格限制访问权限。数据保留：本研究所有原始数据（纸质调查表、电子数据库）自研究结束之日起保留不少于 5 年，符合医院科研数据管理规范与伦理审查要求。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data collection Study subjects: Thyroid cancer patients who underwent surgical treatment and were enrolled in this study, all of whom signed informed consent forms. Collectors: Data collection was completed by 2 specially trained specialist nurses, who received unified training on the application specifications of the Prince-Henry Sore Throat Scale and the Chinese version of the Thyroid Cancer-Specific Quality of Life Scale, standardization of scoring criteria, investigation skills and data recording requirements, and only participated in data collection after passing the post-training assessment. Collection indicators: 1 Baseline characteristics of patients, including gender, age, pathological type of tumor, tumor stage, surgical method, and past medical history; 2 Postoperative outcome indicators, including postoperative sore throat scores assessed by the Prince-Henry Scale at 24 h and 72 h after returning to the ward, and quality of life scores assessed by the Chinese version of the Thyroid Cancer-Specific Quality of Life Scale at 24 h and 72 h after returning to the ward. Methods and time: After patients returned to the ward, the trained collectors conducted one-on-one on-site assessment and data recording using a unified paper questionnaire at the preset time points (24 h, 72 h). Standardized answers were provided to the subjects' questions during the questionnaire filling to ensure the authenticity and accuracy of the scores. The questionnaires were checked on-site for no missing or wrong items before confirmation and filing. Data management Data entry: The collected paper questionnaires were independently double-entered into a raw database by 2 independent researchers using EpiData 3.1 software, following the principle of "one entry and one verification" to avoid entry errors. Data quality control: After the database was established, abnormal values, missing values and logically contradictory data were identified through the logical verification function of the software. Doubtful data were immediately cross-checked with the original questionnaires, and the collectors were contacted for traceability verification and correction. Missing values were supplemented by reasonable methods (e.g., telephone follow-up) to ensure data integrity and accuracy. Consistency test was performed for all scale scores to ensure the reliability of the scoring results. Data storage and privacy protection: The original paper questionnaires were sorted, sealed and filed in a special filing cabinet of the department. The electronic database was encrypted (with access password set) and stored in a special scientific research computer of the hospital department. All data were de-identified to protect patient privacy, with identifiable information such as name, hospital registration number and ID number concealed, and only the study subjects were identified by serial numbers. The original data and database were kept by special personnel with strictly restricted access rights. Data retention: All raw data of this study (paper questionnaires and electronic database) were retained for at least 5 years from the end of the study, in compliance with the hospital's scientific research data management norms and ethical review requirements
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：	2026-03-31 08:37:34