ChiCTR2400091426 版本V1.0 版本创建时间2024/10/28 17:54:44 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：

 ChiCTR2400091426 

最近更新日期：

Date of Last Refreshed on：

 2024-10-28 17:54:39 

注册时间：

Date of Registration：

 2024-10-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于棋盘游戏的学龄期儿童扁桃体术后疼痛管理方案的构建及应用

Public title：

Construction and application of a pain management program for school-age children after tonsillectomy based on board games

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于棋盘游戏的学龄期儿童扁桃体术后疼痛管理方案的构建及应用

Scientific title：

Construction and application of a pain management program for school-age children after tonsillectomy based on board games

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：

张爱花 

研究负责人：

张爱花 

Applicant：

zhangaihua 

Study leader：

zhangaihua 

申请注册联系人电话：

Applicant telephone：

 +86 182 5053 5598

研究负责人电话：

Study leader's
telephone：

+86 182 5053 5598

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：

 1016616750@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 1016616750@qq.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：

福建省莆田市荔城区秀水华庭B区5号楼1001

研究负责人通讯地址：

福建省莆田市荔城区秀水华庭B区5号楼1001

Applicant address：

Building 1001, Block 5, Block B, Xiushui huating, Licheng District, Putian, Fujian province

Study leader's address：

Building 1001, Block 5, Block B, Xiushui huating, Licheng District, Putian, Fujian province

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：

莆田学院附属医院

Applicant's institution：

Putian College Hospital

研究负责人所在单位：

莆田学院附属医院

Affiliation of the Leader：

Putian College 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：

 莆医附伦[202487]

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：

莆田学院附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of Putian College Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-05-08 00:00:00

伦理委员会联系人：

郭刚

Contact Name of the ethic committee：

guogang

伦理委员会联系地址：

福建省莆田市东圳东路999号莆田学院附属医院

Contact Address of the ethic committee：

Affiliated Hospital of Putian College, 999 dongzhen East Road, Putian, Fujian province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 158 6008 9183

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：

莆田学院附属医院

Primary sponsor：

Putian College Hospital

研究实施负责（组长）单位地址：

福建省莆田市东圳东路999号莆田学院附属医院

Primary sponsor's address：

Affiliated Hospital of Putian College, 999 dongzhen East Road, Putian, Fujian province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

福建省

市(区县)：

莆田市

Country：

CHINA

Province：

Fujian province

City：

单位(医院)：

莆田学院附属医院

具体地址：

福建省莆田市东圳东路999号莆田学院附属医院

Institution
hospital：

Putian College Hospital

Address：

Affiliated Hospital of Putian College, 999 dongzhen East Road, Putian, Fujian province

经费或物资来源：

研究者自费

Source(s) of funding：

Researchers pay for themselves

研究疾病：

扁桃体炎  

Target disease：

Tonsils

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1、构建学龄期儿童扁桃体术后疼痛棋盘游戏方案。 2、评价棋盘游戏在儿童扁桃体术后疼痛管理的应用效果。  

Objectives of Study：

1. To construct the scheme of school-age children's pain board game after tonsillectomy. 2. To evaluate the effect of board game on pain management after tonsillectomy in children.

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年龄6-12岁；②符合慢性扁桃体炎或阻塞性呼吸暂停综合征诊断标准[13]，全麻行低温等离子辅助下扁桃体切除手术的患儿；③患儿治疗依从性良好，具备一定的理解、阅读及沟通能力，能够配合完成研究；④住院期间家庭照顾者为患儿父母且思维清晰，能够正确阅读文字、回答问题并积极配合者。

Inclusion criteria

1 children aged 6-12 years; 2 children who met the diagnostic criteria for chronic tonsillitis or obstructive apnea syndrome [13] and who underwent tonsillectomy with hypothermic plasma-assisted general anesthesia; 3 children with good treatment compliance; 4 during hospitalization, the family caregivers were the parents with clear thinking, who could read the words correctly, answer the questions and cooperate actively.

排除标准：

①有视力、听力障碍影响沟通的患儿；②患儿因其他疾病而诱发的急慢性疼痛史；③对疼痛刺激反应强烈的疼痛过敏患儿；④凝血功能异常；⑤干预期间，因患儿不适未完整参与整局游戏的患儿。

Exclusion criteria：

1 children with visual and hearing impairment, 2 history of acute and chronic pain induced by other diseases, 3 children with hyperalgesia, 4 abnormal coagulation function, 5 period of intervention, children who did not participate in the whole game because of their discomfort.

研究实施时间：

Study execute time：

从 From 2024-11-01 00:00:00至 To 2025-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-11-01 00:00:00 至 To 2025-03-31 00:00:00

干预措施：

Interventions：

组别：

实验组

样本量：

 77

Group：

Experimental group

Sample size：

干预措施：

在常规护理的基础上增加棋盘游戏干预，具体措施如下： （1）成立干预小组：由1名护士长，2名耳鼻喉专科护士及研究者本人 组成，护士长负责鼓励及维持游戏干预顺利进行，避免其他因素干扰游戏开展。专科护士及研究者负责棋盘游戏的干预实施。 （2）同质化培训：对干预小组进行同质化培训，主要包括游戏的设计理念、内容、规则、奖惩制度、疼痛管理相关维度、疼痛管理目标等；向家属介绍问卷的填写的目的，指导家属术后正确评估的方式及问卷的填写方法。 （3）干预时间：进行6次疼痛管理棋盘游戏干预，从围手术期开始，术前一天、术后1天、术后2天进行棋盘游戏。在干预当天上午及下午对患儿进行游戏干预，一天2次，每次以玩家走完全程棋盘为主。 （4）干预方法：分组进行，每组2~4人，参与者为一组或两组家庭在同病房中开展，要求每组家庭参与者为一位患儿及一位家属。本研究由1名经过疼痛管理棋盘游戏培训合格的研究人员对每组患者进行疼痛教育棋盘游戏，由参与研究方案开发的护士作为裁判，以判断游戏中儿童回答问题及康复训练演示的准确性。

干预措施代码：

Intervention：

On the basis of routine nursing, the intervention of board game was added, and the specific measures were as follows: (1) to set up an intervention group, which was composed of 1 head nurse, 2 nurses specializing in otorhinolaryngology and the researcher himself, the head nurse is responsible for encouraging and maintaining the smooth progress of the game intervention, to avoid other factors interfering with the game. Specialist nurses and researchers were responsible for the implementation of the board game intervention. (2) homogenous training: training the intervention group to homogenous training, including the design concept, content, rules, reward and punishment system, related dimensions of pain management, pain management objectives, etc. The purpose of filling in the questionnaire was introduced to the family members, and the methods of correct evaluation and filling in the questionnaire were guided. (3) intervention time: 6 times of pain management board games were performed, starting from perioperative period, one day before operation, one day after operation and two days after operation. In the morning and afternoon of the intervention day of the children with game intervention, 2 times a day, each time to the players walk the whole course of the main chessboard. (4) intervention methods: 2 ~ 4 persons in each group were divided into two groups. The participants were one group or two groups of families in the same ward. The study was conducted with a pain management board game trained by a qualified researcher to teach pain to each group of patients, and was adjudicated by a nurse who participated in the development of the study protocol, in order to judge the accuracy of children's answers to questions and the demonstration of rehabilitation training.

Intervention code：

组别：

对照组

样本量：

 77

Group：

Control group

Sample size：

干预措施：

术前对患儿及家属做好疼痛健康宣教及心理护理，讲解疾病相关知识，告知疼痛发生的原因、持续时间、评估方法及转移注意力的技巧；术后早期饮食给予流质，逐渐完成饮食过渡；术后给予耳后高乌甲贴72h止痛、颈部冰敷，术后按需口服布洛芬混悬液（VAS评分大于4分且经家属同意，总量＜200mg，每次间隔时间＞4h），若发现异常情况及时上报医务人员。

干预措施代码：

Intervention：

According to the usual tonsil routine pain care in the hospital. Before the operation, the children and their families should be given pain health education and psychological care, explain the relevant knowledge of the disease, and inform the cause, duration, assessment method and diversionary skills of pain. Fluids were given to the diet in the early postoperative period to gradually complete the dietary transition; After the operation, the high black nail patch behind the ear was given for 72 hours to relieve pain, ice compress on the neck, and oral ibuprofen suspension (VAS score greater than 4 points and with the consent of the family, the total amount was < 200mg, and the interval between each time was >4h), and if any abnormalities were found, it should be reported to the medical staff in time.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建省 

市(区县)：

 莆田市 

Country：

CHINA

Province：

Fujian province

City：

单位(医院)：

 莆田学院附属医院 

单位级别：

 三甲 

Institution
hospital：

Putian College Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

疼痛情况

指标类型：

主要指标

Outcome：

PAIN SCORE

Type：

Primary indicator

测量时间点：

测量方法：

vas评分

Measure time point of outcome：

Measure method：

指标中文名：

唾液皮质醇

指标类型：

次要指标

Outcome：

Salivary cortisol

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疼痛灾难化

指标类型：

次要指标

Outcome：

Pain catastrophizing

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

儿童术后行为

指标类型：

次要指标

Outcome：

Postoperative behavior in children

Type：

Secondary indicator

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：

唾液

组织：

Sample Name：

Salivary cortisol

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 6 岁 years
最大 Max age 12 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）：

选取160名学龄期患儿通过分层抽样法根据年龄进行抽样，6~9岁为低龄组80名，10~12岁为高龄组80名。分别对两组年龄层儿童采用随机数字表法进行抽样，每组40人被随机分配到对照组，40人被随机分配到试验组。将随机分配的数字按顺序编号并放入不透光的密封信封中，由与研究无关的第三方人员保管。于福建省某三级甲等医院连续纳入符合纳排标准的研究对象，根据患儿入院顺序编号，第三方按顺序打开信封并将患儿分配到相应组别。

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

160 school-age children were selected by stratified sampling according to their ages. 80 children aged 6 ~ 9 years were in the low age group and 80 children aged 10 ~ 12 years were in the high age group. Two groups of children were sampled by random number table method, 40 in each group were randomly assigned to the control group, 40 were randomly assigned to the trial group. Randomly assigned numbers are numbered sequentially and placed in opaque sealed envelopes in the custody of a third party unrelated to the study. In a Grade III, Class A hospital in Fujian province, subjects who met the inclusion criteria were consecutively enrolled. According to the Order of admission of the children, the third party opened the envelopes in sequence and assigned the children to the corresponding groups.

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：

单盲：除研究者外，受试者不知晓自己的分组情况

Blinding：

Single Blind:Subjects were not aware of their grouping, except for the investigator

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

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）：

2025年7月1日，采用网络平台，中国临床试验中心平台：https://www.chictr.org.cn/index.html

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

July 2025.http://www.medresman.org.cn/login.aspx Upload the test data after the end of the experiment.

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：

资料收集表 EXCEL 电子记录

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

Data collection form Excel electronic record

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：

  2024-10-28 17:54:39