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Observation of the therapeutic effect of Twelve-Section Brocade on postoperative insomnia in patients with colorectal cancer and its influence on anxiety and depression

注册号：

Registration number：

ITMCTR2025000191

最近更新日期：

Date of Last Refreshed on：

2025-01-26

注册时间：

Date of Registration：

2025-01-26

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

十二段锦对结直肠癌患者术后失眠的疗效观察 及对焦虑、抑郁情绪的影响

Public title：

Observation of the therapeutic effect of Twelve-Section Brocade on postoperative insomnia in patients with colorectal cancer and its influence on anxiety and depression

注册题目简写：

十二段锦对结直肠癌患者术后失眠及情绪的影响

English Acronym：

Effects of Twelve-Section Brocade on insomnia and mood in colorectal cancer patients after surgery

研究课题的正式科学名称：

十二段锦对结直肠癌患者术后失眠的疗效观察 及对焦虑、抑郁情绪的影响

Scientific title：

Observation of the therapeutic effect of Twelve-Section Brocade on postoperative insomnia in patients with colorectal cancer and its influence on anxiety and depression

研究课题的正式科学名称简写：

Scientific title acronym：

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：

林丽艳

研究负责人：

林丽艳

Applicant：

Li-Yan Lin

Study leader：

Li-Yan Lin

申请注册联系人电话：

Applicant telephone：

13915994409

研究负责人电话：

Study leader's telephone：

13915994409

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：

401398319@qq.com

研究负责人电子邮件：

Study leader's E-mail：

401398319@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：

南京市秦淮区白下路242号南京市红十字医院2号楼6楼

研究负责人通讯地址：

南京市秦淮区白下路242号南京市红十字医院2号楼6楼

Applicant address：

6th Floor Building 2 Nanjing Red Cross Hospital 242 Baixia Road Qinhuai District Nanjing City.

Study leader's address：

6th Floor Building 2 Nanjing Red Cross Hospital 242 Baixia Road Qinhuai District Nanjing City.

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：

南京市红十字医院

Applicant's institution：

Nanjing Red Cross Hospital

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：

HSZYY-2025-01

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：

南京市红十字医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Nanjing Red Cross Hospital.

伦理委员会批准日期：

Date of approved by ethic committee：

2025/1/8 0:00:00

伦理委员会联系人：

沈超

Contact Name of the ethic committee：

Chao Shen

伦理委员会联系地址：

南京市秦淮区白下路242号南京市红十字医院4号楼3楼

Contact Address of the ethic committee：

3rd Floor Building 4 Nanjing Red Cross Hospital 242 Baixia Road Qinhuai District Nanjing City.

伦理委员会联系人电话：

Contact phone of the ethic committee：

025-86642480

伦理委员会联系人邮箱：

Contact email of the ethic committee：

1143312683@qq.com

研究实施负责（组长）单位：

南京市红十字医院

Primary sponsor：

Nanjing Red Cross Hospital

研究实施负责（组长）单位地址：

南京市秦淮区白下路242号

Primary sponsor's address：

242 Baixia Road Qinhuai District Nanjing City.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏

市(区县)：

南京市 / 秦淮区

Country：

China

Province：

Jiangsu

City：

Nanjing/ Qinhuai District

单位(医院)：

南京市红十字医院

具体地址：

南京市秦淮区白下路242号

Institution
hospital：

Nanjing Red Cross Hospital

Address：

Baixia Road Qinhuai District Nanjing City.

经费或物资来源：

自筹

Source(s) of funding：

self-raised funds

研究疾病：

失眠

研究疾病代码：

7A01

Target disease：

Insomnia

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：

本研究旨在探讨为期两周的十二段锦练习对结直肠癌患者术后失眠和焦虑、抑郁的影响。通过对比练习前后的变化，我们可以更准确地评估十二段锦作为一种非药物干预手段的效果和可行性。

Objectives of Study：

This study aims to explore the effects of a two-week practice of Twelve-Section Brocade on postoperative insomnia, anxiety, and depression in patients with colorectal cancer. By comparing the changes before and after the practice, we can more accurately assess the effectiveness and feasibility of Twelve-Section Brocade as a non-pharmacological intervention.

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符合2023年发布的《中国结直肠癌诊疗规范》中结直肠癌诊断标准的结直肠癌术后恢复期的患者； ②对自身结直肠癌治疗知情的患者； ③符合《中国成人失眠诊断与治疗指南》(2023版)中短期失眠的症状描述； ④符合《中医内科学》中不寐证的症状描述； ⑤入组时PQSI≥7分者； ⑥年龄18~75岁，性别不限； ⑦患者自愿参加本研究并签署知情同意书。

Inclusion criteria

① Patients in the postoperative recovery period of colorectal cancer who meet the diagnostic criteria for colorectal cancer outlined in the "Chinese Guidelines for Diagnosis and Treatment of Colorectal Cancer" released in 2023; ② Patients who are informed about their own colorectal cancer treatment; ③ Patients who meet the symptom description of short-term insomnia in the "Chinese Guideline for the Diagnosis and Treatment of Adult Insomnia" (2023 edition); ④ Patients who meet the symptom description of insomnia (insomnia disorder) in "Traditional Chinese Medicine Internal Medicine"; ⑤ Patients with a Pittsburgh Sleep Quality Index (PQSI) score of ≥7 at the time of enrollment; ⑥ Patients aged 18 to 75 years regardless of gender; ⑦ Patients who voluntarily participate in this study and have signed the informed consent form.

排除标准：

①患有其他恶性肿瘤； ②既往曾诊断为失眠症（包括除非器质性失眠的所有失眠）； ③既往曾诊断抑郁症、焦虑症及其他精神疾病者； ④患有严重心脑血管疾病及其他重大疾病者； ⑤存在运动系统疾病无法完成十二段锦习练者； ⑥正在参与其他临床试验者； ⑦明确诊断但尚未手术的患者； ⑧结直肠癌术前及术后接受放化疗的患者。

Exclusion criteria：

① Patients with other malignant tumors; ② Patients previously diagnosed with insomnia (including all forms of insomnia except for non-organic insomnia); ③ Patients previously diagnosed with depression anxiety or other mental illnesses; ④ Patients with severe cardiovascular and cerebrovascular diseases or other major illnesses; ⑤ Patients with motor system diseases who are unable to complete the Twelve-Section Brocade exercise; ⑥ Patients currently participating in other clinical trials; ⑦ Patients with a confirmed diagnosis but have not undergone surgery; ⑧ Patients with colorectal cancer who have received radiotherapy or chemotherapy before or after surgery.

研究实施时间：

Study execute time：

从From 2025-02-01

至To      2025-10-31

征募观察对象时间：

Recruiting time：

从From 2025-02-01

至To      2025-10-31

干预措施：

Interventions：

组别：

对照组

样本量：

35

Group：

The control group

Sample size：

干预措施：

常规健康指导

干预措施代码：

Intervention：

Conventional health guidance

Intervention code：

组别：

试验组

样本量：

35

Group：

The experimental group

Sample size：

干预措施：

常规健康指导联合十二段锦

干预措施代码：

Intervention：

Conventional health guidance combined with Twelve-Section Brocade

Intervention code：

样本总量 Total sample size ： 70

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

江苏

市(区县)：

南京市 / 秦淮区

Country：

China

Province：

Jiangsu

City：

Nanjing/ Qinhuai District

单位(医院)：

南京市红十字医院

单位级别：

二级甲等

Institution/hospital：

Nanjing Red Cross Hospital

Level of the institution：

Grade A Second-Tier

测量指标：

Outcomes：

指标中文名：

实际睡眠时间情况

指标类型：

次要指标

Outcome：

Actual sleep duration

Type：

Secondary indicator

测量时间点：

干预前、干预1天、3天、5天进行测量

测量方法：

智能运动手环进行监测

Measure time point of outcome：

Measurements were taken before the intervention and on days 1 3 and 5 of the intervention.

Measure method：

Monitored by a smart fitness bracelet.

指标中文名：

心率

指标类型：

次要指标

Outcome：

Heart rate

Type：

Secondary indicator

测量时间点：

住院期间十二段锦锻炼时测量

测量方法：

智能运动手环进行监测

Measure time point of outcome：

Measured during the practice of Twelve-Section Brocade exercise during hospitalization.

Measure method：

Monitored by a smart fitness bracelet.

指标中文名：

阿森斯失眠量表

指标类型：

主要指标

Outcome：

Athens Insomnia Scale

Type：

Primary indicator

测量时间点：

干预前、干预结束后进行测量

测量方法：

被测者独立完成量表的填写，根据自己在过去一个月内的睡眠经历，对每个项目进行打分。共分８个条目，分别是：入睡时间、夜间苏醒、比期望的时间早醒、总睡眠时间、总睡眠质量、白天情绪、白天身体功能和白天思睡。

Measure time point of outcome：

Measurements were taken before and after the intervention.

Measure method：

The participants completed the scale independently based on their sleep experiences over the past month rating each item accordingly. The scale consists of 8 items: sleep onset latency nocturnal awakenings awakening earlier than desired total sleep duration overall sleep quality daytime mood daytime physical functioning and daytime sleepiness.

指标中文名：

匹兹堡睡眠质量指数量表

指标类型：

主要指标

Outcome：

Pittsburgh Sleep Quality Index

Type：

Primary indicator

测量时间点：

干预前、干预结束后进行测量

测量方法：

被试者自行填写19个自评条目和由与被试者同寝的人填写5个他评条目，包括7个维度（主观睡眠质量、入睡时间、睡眠时间、睡眠效率、睡眠障碍、催眠药物、日间功能障碍）评价患者近1个月的睡眠质量。

Measure time point of outcome：

Measurements were taken before and after the intervention.

Measure method：

Participants self-reported 19 self-assessment items, and a roommate or someone sharing the same sleeping quarters with the participant completed 5 observer-rated items, covering 7 dimensions (subjective sleep quality, sleep onset latency, sleep duration, sleep efficiency, sleep disturbances, use of hypnotic medication, and daytime dysfunction) to evaluate the participant's sleep quality over the past month.

指标中文名：

结直肠癌生活质量测定量表

指标类型：

次要指标

Outcome：

Functional Assessment of Cancer Therapy-colorectal

Type：

Secondary indicator

测量时间点：

干预前、干预结束后进行测量

测量方法：

由测量癌症患者共性模块和结直肠癌特异模块构成。其中由5个维度组成，分别为：生理状况、情感状况、社会/家庭状况、功能状况和结直肠癌附加关注。每个条目均釆用0-4分，5个评分等级。生活质量评分为各领域评分相加，评分分数越高说明生活质量越好。

Measure time point of outcome：

Measurements were taken before and after the intervention.

Measure method：

It consists of a common module for cancer patients and a specific module for colorectal cancer. It comprises five dimensions: physical status emotional status social/family status functional status and additional concerns related to colorectal cancer. Each item is rated on a scale of 0-4 with five rating levels. The quality of life score is the sum of the scores in each domain with higher scores indicating better quality of life.

指标中文名：

焦虑自评量表

指标类型：

次要指标

Outcome：

Self-rating Anxiety Scale

Type：

Secondary indicator

测量时间点：

干预前、干预结束后进行测量

测量方法：

受测者需根据自己最近一周的真实感受，独立完成量表的填写，不受他人影响。如果受测者文化程度较低，理解困难，可由工作人员逐条念给他听，但评定仍由受测者独自做出。

Measure time point of outcome：

Measurements were taken before and after the intervention.

Measure method：

Participants should complete the questionnaire independently based on their genuine feelings over the past week without influence from others. If a participant has a low level of education and finds it difficult to understand a staff member may read each item aloud to them but the evaluation should still be made independently by the participant.

指标中文名：

抑郁自评量表

指标类型：

次要指标

Outcome：

Self-Rating Depression Scale

Type：

Secondary indicator

测量时间点：

干预前、干预结束后进行测量

测量方法：

受测者需根据自己最近一周的真实感受，独立完成量表的填写，不受他人影响。如果受测者文化程度较低，理解困难，可由工作人员逐条念给他听，但评定仍由受测者独自做出。

Measure time point of outcome：

Measurements were taken before and after the intervention.

Measure method：

Participants should complete the questionnaire independently based on their genuine feelings over the past week without influence from others. If a participant has a low level of education and finds it difficult to understand a staff member may read each item aloud to them but the evaluation should still be made independently by the participant.

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 75 岁
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）：

由林丽艳用SPSS软件生成的随机数字表产生随机数列

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

A random number sequence was generated using the random number table created by Lin Liyan with SPSS software.

盲法：

Blinding：

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）：

不共享

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

Not shared

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

数据管理委员会：

Data Managemen Committee：

无

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):

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