ChiCTR2500105113 版本V1.0 版本创建时间2025/06/30 09:20:36 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：

 ChiCTR2500105113 

最近更新日期：

Date of Last Refreshed on：

 2025-06-30 09:20:27 

注册时间：

Date of Registration：

 2025-06-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

改良下机操作对视频脑电住院患者疼痛的影响

Public title：

The influence of improved disassembly operation on the pain of inpatients with video electroencephalogram

注册题目简写：

English Acronym：

研究课题的正式科学名称：

改良下机操作对视频脑电住院患者疼痛的影响

Scientific title：

The influence of improved disassembly operation on the pain of inpatients with video electroencephalogram

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：

曾繁丽 

研究负责人：

曾繁丽 

Applicant：

Fanli Zeng 

Study leader：

Fanli Zeng 

申请注册联系人电话：

Applicant telephone：

 +86 185 7730 9685

研究负责人电话：

Study leader's
telephone：

+86 185 7730 9685

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：

 zengfanli@sysush.com

研究负责人电子邮件：

Study leader's E-mail：

 zengfanli@sysush.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：

广东省深圳市光明区新湖街道圳园路628号

研究负责人通讯地址：

广东省深圳市光明区新湖街道圳园路628号

Applicant address：

No. 628, Zhenyuan Road, Xinhua Sub-district, Guangming District, Shenzhen, Guangdong

Study leader's address：

No. 628, Zhenyuan Road, Xinhua Sub-district, Guangming District, Shenzhen, Guangdong

申请注册联系人邮政编码：

Applicant postcode：

 518107

研究负责人邮政编码：

Study leader's postcode：

 518107

申请人所在单位：

中山大学附属第七医院

Applicant's institution：

The Seventh Affiliated Hospital, Sun Yat-sen University

研究负责人所在单位：

中山大学附属第七医院

Affiliation of the Leader：

The Seventh Affiliated Hospital, Sun Yat-sen University

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：

 KY-2025-092-02

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：

中山大学附属第七医院（深圳）科研伦理委员会

Name of the ethic committee：

Research Ethics Committee of the Seventh Affiliated Hospital of Sun Yat-sen University (Shenzhen)

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-04-24 00:00:00

伦理委员会联系人：

唐燕

Contact Name of the ethic committee：

Yan Tang

伦理委员会联系地址：

广东省深圳市光明区新湖街道圳园路628号

Contact Address of the ethic committee：

No. 628, Zhenyuan Road, Xinhua Sub-district, Guangming District, Shenzhen, Guangdong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 133 1619 5457

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 tangyan2@sysush.com

研究实施负责（组长）单位：

中山大学附属第七医院

Primary sponsor：

The Seventh Affiliated Hospital, Sun Yat-sen University

研究实施负责（组长）单位地址：

广东省深圳市光明区新湖街道圳园路628号

Primary sponsor's address：

No. 628, Zhenyuan Road, Xinhua Sub-district, Guangming District, Shenzhen, Guangdong

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)：

深圳

Country：

China

Province：

Guangdong

City：

Shenzhen

单位(医院)：

中山大学附属第七医院

具体地址：

广东省深圳市光明区新湖街道圳园路628号

Institution
hospital：

The Seventh Affiliated Hospital, Sun Yat-sen University

Address：

No. 628, Zhenyuan Road, Xinhua Sub-district, Guangming District, Shenzhen, Guangdong

经费或物资来源：

中山大学附属第七医院神经内科科研培育基金

Source(s) of funding：

The Neurology Department Research and Cultivation Fund of the Seventh Affiliated Hospital of Sun Yat-sen University

研究疾病：

癫痫  

Target disease：

Epilepsy

研究疾病代码：

G40

Target disease code：

G40

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：

随机平行对照 

Study design：

Parallel 

研究目的：

验证改良下机操作是否会减轻住院行视频脑电患者的疼痛感，是否可以提高患者的住院满意度。  

Objectives of Study：

To verify whether the improved disassembly operation will alleviate the pain of hospitalized patients undergoing video electroencephalogram and whether it can improve the hospitalization satisfaction of patients.

药物成份或治疗方案详述：

选取我院2025年7月1日-2026年7月1日的需要做视频脑电的住院患者（6-17岁）共172名，不同年龄段进行随机对照单盲研究各86人（对照组A组43人（6-12岁），B组43人（13-17岁），实验组C组43人（6-12岁），实验组D组43人（13-17岁）），通过对研究对象进行数据收集，根据本研究组设计的操作内容来为患者下机，根据疼痛评分表来评估4组间的疼痛感，对于儿童患者可参照面部表情评分法（Wong－Baker 面部表情量表（FPS－R），FPS－R量表用从微笑－悲伤至哭泣的6种表情来代表不同程度疼痛，评估时只需患儿从中选出一个代表疼痛程度的表情即可。此量表使用范围较广，适用于各年龄段小儿，不需要患儿有特定的文化背景，易于掌握。），青少年患者可用数字评分法（数字评分法是一种常见的疼痛评估方法，要求患者根据自身感受将疼痛程度从0-10进行打分，其中0表示无痛，10表示最剧烈的疼痛。这种方法简单易用，适用于大多数患者，尤其是成人和青少年）。 1.对照组的下机操作内容：仅使用常规操作，即手撕胶布下机 2.实验组的下机操作内容：在对照组的基础上，使用防水头围帽将患者头部围绕，肩上垫防水毛巾，避免洒温水时喷湿患者面部及衣服，可减少不适感。对于洒水还难以撕下的胶布可使用医用的去处胶布的专用水，尤其的面部和耳电极处，极易损伤患者皮肤。 3.实验组和对照组均签署视频脑电下机操作疼痛感研究的知情同意书，护士告知并嘱患者或家属签署知情同意书。 

Description for medicine or protocol of treatment in detail：

A total of 172 inpatients (aged 6-17 years) who needed video electroencephalogram in our hospital from July 1, 2025 to July 1, 2026 were selected. A randomized controlled single-blind study was conducted in different age groups, with 86 people in each group (43 people in group A (aged 6-12 years), 43 people in Group B (aged 13-17 years), and 43 people in Group C (aged 6-12 years) of the experimental group). In the experimental group D, there were 43 people (aged 13-17). Through data collection of the research subjects, the patients were disinfected from the machine according to the operation content designed by our research group. The pain perception among the four groups was evaluated according to the pain score sheet. For child patients, the facial expression scoring method (Wong-Baker Facial Expression Scale (FS-R)) could be referred to. The FS-R scale uses six expressions ranging from smiling to sad to crying to represent different degrees of pain. During the assessment, only one expression representing the degree of pain needs to be selected from the children. This scale has a wide range of applications and is suitable for children of all ages. It does not require the child to have a specific cultural background and is easy to master. For adolescent patients, the numerical scoring method can be used. (The numerical scoring method is a common pain assessment method. It requires patients to rate the degree of pain from 0 to 10 based on their own feelings, where 0 indicates no pain and 10 indicates the most severe pain.) This method is simple and easy to use, and is suitable for most patients, especially adults and teenagers. The operation content of the control group getting off the machine: Only the conventional operation was used, that is, getting off the machine by hand tearing off the adhesive tape 2. The content of the disassembly operation in the experimental group: On the basis of the control group, a waterproof head cap was used to surround the patient's head, and a waterproof towel was placed on the shoulder to prevent the patient's face and clothes from being wet when warm water was sprayed, which could reduce discomfort. For adhesive tapes that are difficult to remove even after sprinkling water, special water for removing adhesive tapes in medical use can be used, especially at the facial and ear electrodes, which can easily damage the patient's skin. 3. Both the experimental group and the control group signed the informed consent form for the study on pain perception during the operation of the video electroencephalogram machine. The nurses informed and instructed the patients or their families to sign the informed consent form. 

纳入标准：

纳入标准： 1.在我科需做视频脑电图检查的患者，病情趋于稳定 2.年龄在6至17岁的患者（儿童组6-12岁，青少年组13-17岁） 3.患者意识清楚及家属能配合观察记录调查表 4.3个月内未参加其他临床研究 5.未发生不良事件 6.同意加入本次研究

Inclusion criteria

Inclusion criteria: Patients who need to undergo video electroencephalogram (EEG) examinations in our department tend to have stable conditions 2. Patients aged 6 to 17 years (children's group 6-12 years old, adolescent group 13-17 years old) 3. The patient is conscious and the family members can cooperate to observe and record the questionnaire 3. No participation in other clinical studies within 3 months 5. No adverse events occurred 6. Agree to participate in this research

排除标准：

排除标准： 1.非视频脑电监测患者 2.年龄<6岁，或≥18岁的患者 3.不能配合观察记录调查表的患者（语言或意识障碍、严重认知或精神障碍者、病情不稳定、恶化患者） 4.不同意加入本次研究的患者

Exclusion criteria：

Exclusion criteria: 1. Patients not monitored by video electroencephalogram 2. Patients aged less than 6 years or 18 years or older 3. Patients who are unable to cooperate with the observation record questionnaire (those with language or consciousness disorders, severe cognitive or mental disorders, unstable or deteriorating conditions) 4. Patients who do not agree to participate in this study

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

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

干预措施：

Interventions：

组别：

试验组A、C组

样本量：

 86

Group：

Experimental Group A and Group C

Sample size：

干预措施：

2.实验组的下机操作内容：在对照组的基础上，使用防水头围帽将患者头部围绕，肩上垫防水毛巾，避免洒温水时喷湿患者面部及衣服，可减少不适感。对于洒水还难以撕下的胶布可使用医用的去处胶布的专用水，尤其的面部和耳电极处，极易损伤患者皮肤。

干预措施代码：

 AC

Intervention：

The content of the disassembly operation in the experimental group: On the basis of the control group, a waterproof head cap was used to surround the patient's head, and a waterproof towel was placed on the shoulder to prevent the patient's face and clothes from being wet when warm water was sprayed, which could reduce discomfort. For adhesive tapes that are difficult to remove even after sprinkling water, special water for removing adhesive tapes in medical use can be used, especially at the facial and ear electrodes, which can easily damage the patient's skin.

Intervention code：

组别：

对照组B、D组

样本量：

 86

Group：

Control Group B and Group D

Sample size：

干预措施：

1.对照组的下机操作内容：仅使用常规操作，即手撕胶布下机

干预措施代码：

 BD

Intervention：

The operation content of the control group getting off the machine: Only the conventional operation was used, that is, getting off the machine by hand tearing off the adhesive tape

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)：

 深圳 

Country：

China

Province：

Guangdong

City：

Shenzhen

单位(医院)：

 中山大学附属第七医院 

单位级别：

 三甲 

Institution
hospital：

The Seventh Affiliated Hospital, Sun Yat-sen University

Level of the institution：

tertiary A

测量指标：

Outcomes：

指标中文名：

疼痛量表评分

指标类型：

主要指标

Outcome：

Pain scale score

Type：

Primary indicator

测量时间点：

操作结束后10min内

测量方法：

量表评估

Measure time point of outcome：

Within 10 minutes after the operation is completed

Measure method：

Scale evaluation

指标中文名：

住院满意度

指标类型：

次要指标

Outcome：

Hospitalization satisfaction

Type：

Secondary indicator

测量时间点：

操作结束后10min内

测量方法：

量表评估

Measure time point of outcome：

Within 10 minutes after the operation is completed

Measure method：

Scale evaluation

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

Tissue：

None

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

None

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 6 岁 years
最大 Max age 17 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）：

区组随机

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

Block randomization

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

研究对象为盲，研究人员不设盲。

Blinding：

The research subjects were blind, but the researchers were not blinded.

是否共享原始数据：

IPD sharing

否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）：

无

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

None

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：

无

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

None

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-06-30 09:20:27