ChiCTR2600117614 版本V1.0 版本创建时间2026/01/27 10:23:18 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：

 ChiCTR2600117614 

最近更新日期：

Date of Last Refreshed on：

 2026-01-27 10:23:09 

注册时间：

Date of Registration：

 2026-01-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

虚拟现实技术对心脏外科手术患者术前焦虑和睡眠质量影响的研究

Public title：

Research on the Effects of Virtual Reality Technology on Preoperative Anxiety and Sleep Quality in Patients Undergoing Cardiac Surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

虚拟现实技术对心脏外科手术患者术前焦虑和睡眠质量影响的研究

Scientific title：

Research on the Effects of Virtual Reality Technology on Preoperative Anxiety and Sleep Quality in Patients Undergoing Cardiac 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：

焦丹丹 

研究负责人：

王晓锋 

Applicant：

Jiao Dandan 

Study leader：

Wang Xiaofeng 

申请注册联系人电话：

Applicant telephone：

 +86 159 3792 1083

研究负责人电话：

Study leader's
telephone：

+86 136 7390 4916

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：

 jdd201304@163.com

研究负责人电子邮件：

Study leader's E-mail：

 13673904916@163.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：

中国河南省洛阳市涧西区景华路24号

研究负责人通讯地址：

中国河南省洛阳市涧西区景华路24号

Applicant address：

No. 24 Jinghua Road, Jianxi District, Luoyang, Henan, China

Study leader's address：

No. 24 Jinghua Road, Jianxi District, Luoyang, Henan, China

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：

河南科技大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Henan University of Science and Technology

研究负责人所在单位：

河南科技大学第一附属医院

Affiliation of the Leader：

The First Affiliated Hospital of Henan University of Science and Technology

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：

 2025-0725

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：

河南科技大学第一附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the First Affiliated Hospital of Henan University of Science and Technology

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-12-12 00:00:00

伦理委员会联系人：

李君

Contact Name of the ethic committee：

Li Jun

伦理委员会联系地址：

中国河南省洛阳市涧西区景华路24号

Contact Address of the ethic committee：

No. 24 Jinghua Road, Jianxi District, Luoyang, Henan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 136 5338 3920

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 Hkdyfyllb@163.com

研究实施负责（组长）单位：

河南科技大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Henan University of Science and Technology

研究实施负责（组长）单位地址：

中国河南省洛阳市涧西区景华路24号

Primary sponsor's address：

No. 24 Jinghua Road, Jianxi District, Luoyang, Henan, 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)：

河南

市(区县)：

洛阳

Country：

China

Province：

Henan

City：

Luoyang

单位(医院)：

河南科技大学第一附属医院

具体地址：

中国河南省洛阳市涧西区景华路24号

Institution
hospital：

The First Affiliated Hospital of Henan University of Science and Technology

Address：

No. 24 Jinghua Road, Jianxi District, Luoyang, Henan, China

经费或物资来源：

暂未申请专项经费,研究成本由项目团队自行承担

Source(s) of funding：

Self-funded by the researcher

研究疾病：

冠心病、心脏瓣膜病及其联合疾病  

Target disease：

Coronary artery disease (CAD), heart valve disease (HVD), and their combined diseases

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：

（1）构建VR技术对心脏外科手术患者术前焦虑和睡眠质量影响的干预方案。 （2）应用VR技术对心脏外科手术患者术前焦虑和睡眠质量影响的干预方案，并验证其效果。  

Objectives of Study：

(1) To develop an intervention program using virtual reality (VR) technology targeting preoperative anxiety and sleep quality in patients undergoing cardiac surgery. (2) To implement the intervention program targeting preoperative anxiety and sleep quality in patients undergoing cardiac surgery using VR technology, and to verify its effectiveness.

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）经术前检查符合冠状动脉旁路移植术、心脏瓣膜直视手术及其联合手术适应症，且同意接受手术者； （2）术前无心血管手术史，无ICU住院史； （3）年龄≥18岁; （4）具备正常沟通能力与读写能力;； （5）自愿参与本研究，并签署知情同意书； （6）无眩晕症、晕动症等VR使用禁忌症

Inclusion criteria

(1)Meet the indications for CABG, open-heart valve surgery, or their combined surgery based on preoperative examinations, and agree to undergo the surgical procedure; (2)No prior history of cardiovascular surgery or intensive care unit admission before the current operation; (3)Aged >= 18 years; (4)Possess normal communication, reading, and writing abilities; (5)Voluntarily agree to participate in this study and sign the informed consent form ; (6)No contraindications to virtual reality (VR) device use, such as vertigo or motion

排除标准：

（1）心脏外科急诊手术； （2）正在使用或接受麻醉药品、镇静剂治疗； （3）既往存在睡眠障碍病史、精神障碍或意识障碍，无法完成本次研究者。 （4）视力或听力严重障碍者

Exclusion criteria：

(1)Emergency cardiac surgery; (2)Current use of or receiving treatment with narcotic drugs or sedatives; (3)Prior history of sleep disorders, mental disorders, or consciousness disorders, and ④inability to complete the study; (4)Severe visual or auditory impairment.

研究实施时间：

Study execute time：

从 From 2026-03-01 00:00:00至 To 2026-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-03-01 00:00:00 至 To 2026-09-30 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 40

Group：

Experimental group

Sample size：

干预措施：

1.初始手术决策日（患者决定接受外科直视手术后），心脏大血管外科谈话间 (1)基线收取 与患者良好沟通，建立良好信任关系；解释研究的目的，并获得他们的书面和口头同意；收集患者一般资料使用；STAI测量焦虑水平、PSQI测量睡眠状况、CPSS测量自觉感知压力，连续检测血压和心率，判断患者是否存在焦虑和睡眠障碍。 (2)协助患者取舒适卧位，佩戴好虚拟现实设备和生理指标检测手环；通过场景内的直观演示与讲解，让患者清晰了解疾病信息，掌握活动锻炼及促进睡眠的原因和要点；时长可设置为8-10分钟，视频结束后，移除VR设备，给予清洁消毒处置；持续监测患者的心率、血压等生理客观指标;；干预后，评估焦虑程度、自觉感知压力，次日晨评估患者睡眠质量。 2.术前1天干预，心脏大血管外科谈话间 干预实施 (1)常规护理；(2)协助患者取舒适卧位，佩戴好虚拟现实设备；通过场景内的直观演示与讲解，让患者清晰了解手术团队，提前熟悉手术环境；时长可设置为6-8分钟，视频结束后，移除VR设备，给予清洁消毒处置；持续监测患者的心率、血压等生理客观指标；干预后，评估焦虑程度、自觉感知压力，次日晨评估患者睡眠质量。 3.手术当日，手术等待区 干预实施 (1)常规护理；(2)协助患者佩戴好虚拟现实设备，使其进入模拟自然场景，播放背景音乐，让患者沉浸在虚拟场景中进行呼吸-放松训练；时长可设置为6-8分钟，视频结束后，移除VR设备，给予清洁消毒处置；持续监测患者的心率、血压等生理客观指标；干预后，评估焦虑程度、自觉感知压力。

干预措施代码：

 VRIG-T

Intervention：

1.Initial Surgical Decision Date (after the patient consents to open-heart surgery) – Cardiothoracic and Vascular Surgery Consultation Room (1) Baseline data collection: Establish a trusting relationship through effective communication with the patient; explain the study objectives and obtain written and verbal informed consent. Collect general demographic data; assess anxiety (State-Trait Anxiety Inventory, STAI), sleep quality (Pittsburgh Sleep Quality Index, PSQI), and perceived stress (Chinese Perceived Stress Scale, CPSS). Conduct continuous monitoring of blood pressure and heart rate to screen for anxiety and sleep disorders. (2) VR intervention implementation: Assist the patient in assuming a comfortable position; fit the virtual reality (VR) device and physiological parameter monitoring bracelet. Deliver disease-related information, exercise guidelines, and sleep promotion strategies via intuitive in-scene demonstrations and explanations (duration: 8–10 minutes). Remove and perform cleaning and disinfection of the VR device post-intervention; continue monitoring objective physiological indicators (heart rate, blood pressure). Reassess anxiety and perceived stress immediately after the intervention; evaluate sleep quality the following morning. 2.Preoperative day 1 intervention – Cardiothoracic and Vascular Surgery Consultation Room (1) Routine nursing care. (2) VR intervention implementation: Assist the patient in assuming a comfortable position; fit the VR device. Facilitate familiarity with the surgical team and operating environment through in-scene demonstrations and explanations (duration: 6–8 minutes). Remove and disinfect the VR device post-intervention; continue monitoring heart rate, blood pressure, and other physiological indicators. Reassess anxiety and perceived stress immediately after the intervention; evaluate sleep quality the following morning. 3.Surgery day – Preoperative Waiting Area (1) Routine nursing care. (2) VR intervention implementation: Fit the VR device on the patient to immerse them in a simulated natural scene with background music; guide breathing-relaxation training (duration: 6–8 minutes). Remove and disinfect the VR device post-intervention; continue monitoring objective physiological indicators (heart rate, blood pressure). Reassess anxiety and perceived stress immediately after the intervention.

Intervention code：

组别：

对照组

样本量：

 40

Group：

Control group

Sample size：

干预措施：

1.初始手术决策日，在心脏大血管外科谈话间与患者良好沟通，建立良好信任关系；解释研究的目的，并获得他们的书面和口头同意；收集患者一般资料使用；STAI测量焦虑水平、PSQI测量睡眠状况、CPSS测量自觉感知压力，同时检测血压、心率，判断患者是否存在焦虑和睡眠质量受损，并于次日晨评估患者睡眠质量。 2.(1)手术前1天，14:00-16:00由手术室统一访视人员进行术前访视；(2)在心脏大血管外科谈话间，根据手术访视记录单内容，逐一对患者进行提问，确认患者手术所需基本信息，了解患者病情，评估患者身体状况；向患者介绍手术相关注意事项及手术流程，告知患者术前需要做好自身准备。认真倾听患者的内心感受，对患者提出的问题给予耐心解答，告知患者术前等待区的注意事项，可适当转移注意力，不要过于紧张；(3)干预后，评估焦虑程度、自觉感知压力，同时检测血压和心率，并于次日晨评估患者睡眠质量。 3.手术日将患者接入术前等待间后，护士热情接待，仔细核对患者信息，对患者进行必要的解释和安慰。解释后评估焦虑程度、自觉感知压力，同时检测血压和心率。 4）将患者接入手术室后严密监测患者的各项生命体征，手术室护士、手术医师、麻醉医师三方核查后进行麻醉诱导，两组实施同种麻醉方式。 5）手术结束后将患者送入外科重症监护病区，对患者进行严密监测

干预措施代码：

 CG-T

Intervention：

1.Initial Surgical Decision Date Conducted in the Cardiothoracic and Vascular Surgery Consultation Room: Establish a trusting relationship through effective communication with the patient; explain the study objectives and obtain written and verbal informed consent. Collect general demographic data; assess anxiety using the State-Trait Anxiety Inventory (STAI), sleep quality via the Pittsburgh Sleep Quality Index (PSQI), and perceived stress with the Chinese Perceived Stress Scale (CPSS). Simultaneously measure blood pressure (BP) and heart rate (HR) to screen for anxiety and impaired sleep quality. Evaluate sleep quality the following morning. 2.Preoperative day 1(1) Routine preoperative visit performed by designated operating room (OR) staff between 14:00–16:00.(2) Conducted in the Cardiothoracic and Vascular Surgery Consultation Room: Conduct a structured interview based on the Preoperative Visit Checklist to verify essential surgical information, review the patient’s medical condition, and assess physical status. Provide education on surgical procedures, preoperative precautions, and self-preparation requirements. Actively listen to the patient’s concerns, respond patiently to inquiries, and advise on preoperative holding area protocols (e.g., distraction techniques to alleviate excessive anxiety). (3) Post-intervention assessments: Reassess anxiety and perceived stress; measure BP and HR. Evaluate sleep quality the following morning. 3.Surgery day-Preoperative Waiting Area Upon admitting the patient to the preoperative holding area, nurses receive the patient warmly, verify demographic and surgical information, and provide necessary explanations and emotional support. Conduct post-explanation assessments: anxiety level, perceived stress, BP, and HR. Operating room phase Continuously monitor vital signs upon the patient’s admission to the OR. Anesthetic induction is performed following three-way verification by the OR nurse, surgeon, and anesthesiologist. Both groups receive the same anesthetic regimen. Postoperative phase Transfer the patient to the Surgical Intensive Care Unit (SICU) immediately after surgery for close monitoring.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河南 

市(区县)：

  

Country：

China

Province：

Henan

City：

单位(医院)：

 河南科技大学第一附属医院 

单位级别：

 三甲 

Institution
hospital：

The First Affiliated Hospital of Henan University of Science and Technology

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

术前焦虑

指标类型：

主要指标

Outcome：

Preoperative Anxiety

Type：

Primary indicator

测量时间点：

测量方法：

状态-特质焦虑量表

Measure time point of outcome：

Measure method：

State-Trait Anxiety Inventory

指标中文名：

术前睡眠质量

指标类型：

主要指标

Outcome：

Preoperative Sleep Quality

Type：

Primary indicator

测量时间点：

测量方法：

匹兹堡睡眠质量指数表

Measure time point of outcome：

Measure method：

Pittsburgh Sleep Quality Index

指标中文名：

术前感知压力

指标类型：

次要指标

Outcome：

Preoperative Perceived Stress

Type：

Secondary indicator

测量时间点：

测量方法：

中文版知觉压力量表

Measure time point of outcome：

Measure method：

Chinese Perceived Stress Scales

指标中文名：

生理指标（心率、血压）

指标类型：

次要指标

Outcome：

Physiological Indicators (Heart Rate, Blood Pressure)

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：

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：

尚未开始

Not yet recruiting

年龄范围：

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

项目指导：焦丹丹 博士 使用随机数字表法生成随机序列

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

Project Supervisor: Dandan Jiao, Ph.D. The random sequence was generated using the random number table method.

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：

1.对患者患者设盲：（1）随机序列生成后，由独立第三方制作 “分组编码表”（仅标注患者 ID+分组代码：VRI=VR 干预组，CG = 常规护理对照组），不记录分组名称；（2）分组编码表密封于不透光信封，由第三方保管，干预实施者仅根据患者 ID 获取编码，不告知患者编码含义；（3）干预组与对照组的干预实施流程完全统一；（4）干预人员仅告知患者 “本研究旨在比较两种术前访视”效果，不提及 “干预组”“对照组”“VR 治疗” 等术语。 2.对数据分析者设盲 （1）研究者在 Excel 表格中仅录入 “患者 ID + 分组代码（VRI/CG+测量指标数据，不记录任何可关联分组的信息； （2）数据收集完成后，由研究者对 Excel 数据进行 “去标识化” 处理：删除患者姓名、住院号等个人身份信息，仅保留 “匿名 ID + 分组代码 + 指标数据”。

Blinding：

1.Blinding of Patients:(1) After the random sequence is generated, an independent third party will create a "Group Coding Table" (only labeling Patient ID + group codes: VRI = VR Intervention Group, CG = Conventional Care Control Group) without recording group names.(2) The Group Coding Table will be sealed in opaque envelopes and kept by the third party. Intervention implementers will only obtain the code based on the patient’s ID without disclosing the meaning of the code to the patients.(3) The intervention implementation process will be fully standardized for both the intervention group and the control group.(4) Intervention staff will only inform patients that "this study aims to compare the effects of two types of preoperative visits" without mentioning terms such as "intervention group", "control group", or "VR therapy". 2.Blinding of Data Analysts:(1) Researchers will only enter "Patient ID + group codes (VRI/CG) + outcome measure data" in Microsoft Excel, without recording any information that can be linked to group allocation.(2) After data collection is completed, researchers will perform a "de-identification" process on the Excel data: remove patients' personal identifiable information (e.g., names, hospital numbers) and retain only "anonymous ID + group codes + outcome data".

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）：

拟于本研究成果发表后 1 个月，通过学术数据共享平台 Figshare 公开原始数据（含元数据及研究方案），平台网址：https://figshare.com/

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

The original data (including metadata and protocol) will be made public via the academic data sharing platform Figshare 1 month after the publication of this study results. The platform URL: https://figshare.com/

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：

1.使用患者信息 Excel 表格作为记录工具，初步整理患者的基线资料、术前焦虑评估结果等研究相关数据； 2.采用基于互联网的电子数据采集与管理系统 ResMan，将 Excel 中整理的患者数据统一进行电子化录入、实时核查与集中管理。

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

1.Use the patient information Excel spreadsheet as a recording tool to preliminarily organize study-related data including patients' baseline data and preoperative anxiety assessment results; 2.Adopt ResMan, an internet-based electronic data capture and management system, to uniformly perform electronic entry, real-time verification, and centralized management of the patient data organized in the Excel spreadsheet.

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：

  2026-01-27 10:23:09