ChiCTR2500109371 版本V1.0 版本创建时间2025/09/17 15:36:28 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：

 ChiCTR2500109371 

最近更新日期：

Date of Last Refreshed on：

 2025-09-17 15:36:10 

注册时间：

Date of Registration：

 2025-09-17 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

术前宣教联合术中音乐疗法对择期剖宫产患者围术期焦虑与疼痛的影响研究

Public title：

Study on the Effect of Preoperative Education Combined with Intraoperative Music Therapy on Perioperative Anxiety and Pain in Patients Undergoing Elective Cesarean Section

注册题目简写：

术前宣教联合术中音乐疗法对择期剖宫产患者围术期焦虑与疼痛的影响

English Acronym：

Preoperative Education Combined with Intraoperative Music Therapy on Perioperative Anxiety and Pain in Elective Cesarean Section Patients

研究课题的正式科学名称：

术前宣教联合术中音乐疗法对择期剖宫产患者围术期焦虑与疼痛的影响研究

Scientific title：

Study on the Effect of Preoperative Education Combined with Intraoperative Music Therapy on Perioperative Anxiety and Pain in Patients Undergoing Elective Cesarean Section

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：

左玢卿 

研究负责人：

左玢卿 

Applicant：

Zuo Binqing 

Study leader：

Zuo Binqing 

申请注册联系人电话：

Applicant telephone：

 +86 158 2764 3432

研究负责人电话：

Study leader's
telephone：

+86 158 2764 3432

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：

 2708641854@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 2708641854@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：

湖北省武汉市洪山区武珞路745号

研究负责人通讯地址：

湖北省武汉市洪山区武珞路745号

Applicant address：

No. 745, Wuluo Road, Hongshan District, Wuhan City

Study leader's address：

No. 745, Wuluo Road, Hongshan District, Wuhan 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：

湖北省妇幼保健院

Applicant's institution：

Hubei Maternal and Child Health Hospital (Hubei Women and Children's Hospital

研究负责人所在单位：

湖北省妇幼保健院

Affiliation of the Leader：

Hubei Maternal and Child Health Hospital (Hubei Women and Children's 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：

 2024-076-01

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：

湖北省妇幼保健院医学伦理审查委员会

Name of the ethic committee：

Medical Ethics Review Committee of Hubei Provincial Maternal and Child Health Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-01-17 00:00:00

伦理委员会联系人：

黄文婷

Contact Name of the ethic committee：

Huang Wenting

伦理委员会联系地址：

武汉市洪山区武珞路745号

Contact Address of the ethic committee：

No. 745, Wuluo Road, Hongshan District, Wuhan City

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 27 8716 9280

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：

湖北省妇幼保健院

Primary sponsor：

Hubei Maternal and Child Health Hospital (Hubei Women and Children's Hospital

研究实施负责（组长）单位地址：

武汉市洪山区武珞路745号

Primary sponsor's address：

No. 745, Wuluo Road, Hongshan District, Wuhan 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)：

湖北省

市(区县)：

武汉市

Country：

China

Province：

Hubei

City：

单位(医院)：

湖北省妇幼保健院

具体地址：

武汉市洪山区武珞路745号

Institution
hospital：

Hubei Maternal and Child Health Hospital (Hubei Women and Children's Hospital

Address：

No. 745, Wuluo Road, Hongshan District, Wuhan City

经费或物资来源：

个人自费

Source(s) of funding：

self-funded

研究疾病：

择期剖宫产患者的围术期焦虑与疼痛  

Target disease：

Perioperative anxiety and pain in patients undergoing elective cesarean section

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：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究旨在探讨术前宣教联合术中音乐疗法对择期剖宫产患者围术期焦虑、疼痛的影响。研究对象为择期在腰硬联合麻醉下行剖宫产患者，采用随机分组的前瞻性研究设计。通过术前系统化宣教及术中音乐干预，采用多维度评估，分析术前宣教联合术中音乐疗法对患者围术期焦虑缓解、疼痛和寒战的影响，以及术后恢复情况和护理满意度的作用。研究结果将为优化剖宫产患者的护理流程提供科学依据，并探索一种可推广的心理与生理双重干预模式，以提升患者整体手术体验和术后恢复质量，为优化剖宫产护理模式提供科学依据。  

Objectives of Study：

The purpose of this study is to explore the impact of preoperative education combined with intraoperative music therapy on perioperative anxiety and pain in patients undergoing elective cesarean section. The research subjects are patients scheduled to undergo cesarean section under combined spinal-epidural anesthesia, and a prospective study design with random grouping is adopted. Through systematic preoperative education and intraoperative music intervention, multi-dimensional evaluations will be conducted to analyze the effects of preoperative education combined with intraoperative music therapy on alleviating perioperative anxiety, pain and chills, as well as their roles in postoperative recovery and nursing satisfaction. The results of this study will provide a scientific basis for optimizing the nursing process for cesarean section patients, and explore a promotable dual intervention model for both psychological and physiological aspects, so as to improve patients' overall surgical experience and postoperative recovery quality, thus offering scientific evidence for optimizing the nursing model of cesarean section.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.18至40岁，单胎妊娠，符合择期剖宫产指征； 2.妊娠期无严重并发症，如妊娠高血压、糖尿病等； 3.能理解并签署知情同意书，愿意参加研究； 4.能够配合进行术前、术后评估，并完成随访。

Inclusion criteria

1. Aged 18 to 40 years, with singleton pregnancy and meeting the indications for elective cesarean section; 2. Without severe complications during pregnancy, such as gestational hypertension, diabetes mellitus, etc.; 3. Able to understand and sign the informed consent form, and willing to participate in the study; 4. Able to cooperate with preoperative and postoperative evaluations and complete follow-up.

排除标准：

1.孕期并发症或其他可能影响研究结果的疾病； 2.孕妇在术前有严重心理疾病，无法理解研究内容； 3.不愿意参与研究或无法完成随访的患者； 4.对音乐或耳机过敏的产妇。

Exclusion criteria：

1. Complications during pregnancy or other diseases that may affect the study results; 2. Pregnant women with severe mental illnesses before surgery, who are unable to understand the study content; 3. Patients who are unwilling to participate in the study or unable to complete follow-up; 4. Parturients allergic to music or headphones.

研究实施时间：

Study execute time：

从 From 2025-01-17 00:00:00至 To 2026-01-16 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-02-14 00:00:00 至 To 2025-07-30 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 58

Group：

Test group

Sample size：

干预措施：

术前宣教（Preoperative education）：术前 1 天接受标准化宣教，内容包括手术流程、术中注意事项、麻醉方法及术后恢复知识，由专职护士负责。 术中音乐疗法（Intraoperative music therapy）：术中全程播放轻音乐、古典音乐或自然声音（可选择个性化音乐），由经过培训的手术室护士实施。

干预措施代码：

Intervention：

Preoperative education: Receive standardized education one day before the operation, which includes the surgical process, intraoperative precautions, anesthesia methods and postoperative recovery knowledge, and is undertaken by full-time nurses. Intraoperative Music Therapy: During the entire surgical procedure, light music, classical music, or natural sounds (personalized music is an option) are played. This therapy is administered by trained operating room nurses.

Intervention code：

组别：

对照组

样本量：

 58

Group：

Control Group

Sample size：

干预措施：

术前宣教（Preoperative education）：术前 1 天接受标准化宣教，内容包括手术流程、术中注意事项、麻醉方法及术后恢复知识，由专职护士负责。

干预措施代码：

Intervention：

Preoperative education: Receive standardized education one day before the operation, which includes the surgical process, intraoperative precautions, anesthesia methods and postoperative recovery knowledge, and is undertaken by full-time nurses.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北省 

市(区县)：

  

Country：

China

Province：

Hubei

City：

单位(医院)：

 湖北省妇幼保健院 

单位级别：

 三级甲等 

Institution
hospital：

Hubei Maternal and Child Health Hospital (Hubei Women and Children's Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

焦虑评分

指标类型：

主要指标

Outcome：

anxiety score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疼痛评分

指标类型：

主要指标

Outcome：

pain score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

寒站指数

指标类型：

次要指标

Outcome：

chill index

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：

无

组织：

Sample Name：

no

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 40 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

随机序列产生人员：由研究团队中不直接参与患者招募和干预实施的统计人员（本研究中为负责 “问卷设计及数据统计” 的夏梦雨护师）完成随机序列的生成，以避免选择偏倚。? 随机序列产生方法：采用随机数字表法（random number table method）。具体操作如下：? 根据预估样本量（总 116 例），从统计学软件（如 SPSS）中生成 116 个随机数字（范围 0-99）；? 按随机数字大小排序，将前 58 例分配至实验组（术前宣教 + 术中音乐疗法），后 58 例分配至对照组（仅术前宣教）；?

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

Explanation of Randomization Method? Person responsible for generating random sequence: The random sequence is generated by a statistician in the research team who is not directly involved in patient recruitment and intervention implementation (in this study, it is Nurse Xia Mengyu, who is responsible for "questionnaire design and data statistics") to avoid selection bias.? Method for generating random sequence: The random number table method is adopted. The specific operations are as follows:? According to the estimated sample size (116 cases in total), 116 random numbers (ranging from 0 to 99) are generated from statistical software (such as SPSS);? The random numbers are sorted by size, with the first 58 cases assigned to the experimental group (preoperative education + intraoperative music therapy) and the last 58 cases assigned to the control group (preoperative education only);?

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：

开放标签，对评估者设盲

Blinding：

Open-label study with blinded-evaluators

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）：

预计共享时间：研究论文正式发表后 3 个月内? 共享方式：通过开放科学框架（Open Science Framework, OSF）平台存储与共享去标识化原始数据集（已移除姓名、身份证号、联系方式等隐私信息）；使用者可在该平台检索本研究题目或 DOI 编号获取数据下载权限，符合数据隐私保护规范及学术共享原则?

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

Method of Sharing Raw Data? Date of publishing raw data: Within 3 months after the official publication of the research paper.? Data sharing method:? The Open Science Framework (OSF) platform (website: https://osf.io/) is used for data storage and sharing.? The shared data are de-identified raw datasets (personal privacy information of patients, such as names, ID numbers, contact information, etc., has been removed), including baseline data, scores of assessment scales at various time points (GAD-7, VAS, chill index, etc.) and records of outcome indicators.? Access method: Data download permission can be obtained by searching the title or DOI number of this study on the above-mentioned platform, so as to ensure compliance with data privacy protection norms and academic sharing principles.?

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（Case Record Form, CRF）? 设计结构化 CRF 表格，内容涵盖研究对象的基线资料（年龄、孕周、妊娠史等）、纳入 / 排除标准核查结果、干预实施记录（术前宣教时间、音乐疗法开始 / 结束时间、音量等）、各时间点评估指标数据（GAD-7 评分、VAS 评分、寒战指数等）及术后结局（下床时间、住院天数、并发症等）。? CRF 由经过培训的研究护士填写，填写完成后由研究组长每例审核，确保数据的完整性和准确性，纸质版 CRF 统一存档于研究中心资料室。? 电子采集和管理系统（Electronic Data Capture, EDC）? 采用基于互联网的 EDC 系统ResMan（网址：https://www.resman.org.cn/）进行电子数据的采集与管理。? 研究人员通过系统账号登录后，将 CRF 中的数据双份录入 ResMan 系统，系统自动进行数据逻辑校验（如范围核查、一致性核查），发现异常数据时自动提示，由研究团队及时溯源并修正。? 系统具备数据加密、权限管理及操作日志记录功能，确保数据的安全性与可追溯性，电子数据与纸质 CRF 定期同步核对，最终以电子数据作为统计分析的基准。?

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

Data Collection and Management? Case Record Form (CRF)? A structured CRF form will be designed, covering the baseline data of the research subjects (age, gestational week, pregnancy history, etc.), verification results of inclusion/exclusion criteria, intervention implementation records (preoperative education time, start/end time of music therapy, volume, etc.), assessment index data at various time points (GAD-7 score, VAS score, chill index, etc.) and postoperative outcomes (time to get out of bed, length of hospital stay, complications, etc.).? The CRF will be filled out by trained research nurses. After completion, each case will be reviewed by the research team leader to ensure the completeness and accuracy of the data. The paper version of the CRF will be uniformly archived in the reference room of the research center.? Electronic Data Capture (EDC) System? The internet-based EDC system ResMan (website: https://www.resman.org.cn/) will be adopted for the collection and management of electronic data.? After logging in with system accounts, researchers will double-enter the data from the CRF into the ResMan system. The system will automatically perform data logic verification (such as range check and consistency check). When abnormal data are found, the system will automatically prompt, and the research team will trace the source and correct them in a timely manner.? The system is equipped with data encryption, authority management and operation log recording functions to ensure data security and traceability. Electronic data and paper CRF will be regularly checked and synchronized, and finally, electronic data will be used as the benchmark for statistical analysis.?

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：

  2025-09-17 15:36:10