ChiCTR2500114637 版本V1.0 版本创建时间2025/12/16 08:44:55 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：

 ChiCTR2500114637 

最近更新日期：

Date of Last Refreshed on：

 2025-12-16 08:44:33 

注册时间：

Date of Registration：

 2025-12-16 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effect of Buteyko Breathing Exercises and Virtual Reality on Anxiety and sleep Quality in Patients poste Coronary Artery Bypass Grafting: A Randomized Controlled Trial

Public title：

Effect of Buteyko Breathing Exercises and Virtual Reality on Anxiety and sleep Quality in Patients poste Coronary Artery Bypass Grafting: A Randomized Controlled Trial

注册题目简写：

BBT-VR-Anxiety-sleep

English Acronym：

BBT-VR-Anxiety-sleep

研究课题的正式科学名称：

Effect of Buteyko Breathing Exercises and Virtual Reality on Anxiety and sleep Quality in Patients poste Coronary Artery Bypass Grafting: A Randomized Controlled Trial

Scientific title：

Effect of Buteyko Breathing Exercises and Virtual Reality on Anxiety and sleep Quality in Patients poste Coronary Artery Bypass Grafting: A Randomized Controlled Trial

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：

Banin kadhum kalf 

研究负责人：

Prof .Hussein Haid, Banin kadhum kalf 

Applicant：

Banin kadhum kalf 

Study leader：

Prof .Hussein Haid, Banin kadhum kalf 

申请注册联系人电话：

Applicant telephone：

 +964 1 540 1609

研究负责人电话：

Study leader's
telephone：

+964 1 848 4407

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：

 banin.kadhum2402@conursing.uobaghdad.edu.iq

研究负责人电子邮件：

Study leader's E-mail：

 husseinatia@conursing.uobaghdad.edu.iq

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：

Baghdad

研究负责人通讯地址：

Baghdad

Applicant address：

Baghdad

Study leader's address：

Baghdad

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：

University of Baghdad -College of Nursing

Applicant's institution：

University of Baghdad -College of Nursing

研究负责人所在单位：

University of Baghdad -College of Nursing

Affiliation of the Leader：

University of Baghdad -College of Nursing

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：

 58

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：

Ethical Committee Approval University of Baghdad -College of Nursing

Name of the ethic committee：

Ethical Committee Approval University of Baghdad -College of Nursing

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-11-30 00:00:00

伦理委员会联系人：

Prof.Hussein Haid

Contact Name of the ethic committee：

Prof.Hussein Haid

伦理委员会联系地址：

University of Baghdad - college of nursing, Baghdad, Iraq

Contact Address of the ethic committee：

University of Baghdad - college of nursing, Baghdad, Iraq

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +964 1 848 4407

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 nursing@uobaghdad.edu.iq

研究实施负责（组长）单位：

University of Baghdad -College of Nursing

Primary sponsor：

University of Baghdad -College of Nursing

研究实施负责（组长）单位地址：

Baghdad

Primary sponsor's address：

Baghdad

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Iraq

省(直辖市)：

Baghdad

市(区县)：

Baghdad

Country：

Iraq

Province：

Baghdad

City：

Baghdad

单位(医院)：

University of Baghdad -College of Nursing

具体地址：

Baghdad

Institution
hospital：

University of Baghdad -College of Nursing

Address：

Baghdad

经费或物资来源：

self-funded

Source(s) of funding：

self-funded

研究疾病：

Anxiety disorder  

Target disease：

Anxiety disorder

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. To evaluate the effectiveness of Buteyko breathing exercise and virtual reality in reducing anxiety and improve sleep quality among patient poste coronary artery Bypass Grafting 2. To compare outcomes between the intervention group (Buteyko breathing exercise only and Buteyko breathing exercise and virtual reality) and control group with routine care  

Objectives of Study：

1. To evaluate the effectiveness of Buteyko breathing exercise and virtual reality in reducing anxiety and improve sleep quality among patient poste coronary artery Bypass Grafting 2. To compare outcomes between the intervention group (Buteyko breathing exercise only and Buteyko breathing exercise and virtual reality) and control group with routine care

药物成份或治疗方案详述：

Before collecting any data, the researcher will gain approval of all participants. this will involve explaining the study objective, procedures, and any potential risks or benefits. participants can give consent either verbally or by signing a consent form. the researcher will emphasize that participants is voluntary and that participants can pull out of the study on either time without facing any repercussions. The researcher will collect data by self-report administered measurement method. A quasi experimental design will be implemented, with three groups Participants in group A underwent Buteyko breathing technique only. Buteyko Breathing Technique Protocol(23,24) The participant took an upright position in a chair, ensuring that their shoulders were relaxed and their lower back was supported against the chair's backrest. They were instructed to execute a gentle inhalation followed by a soft exhalation. Subsequently, the participant was guided to hold their nose during the exhalation phase, maintaining a state of partial lung emptiness without excessive depletion. The duration, measured in seconds, during which the participant comfortably sustained this breath-holding until the initial urge to breathe was noted. Following the breath-holding phase, the participant was instructed to release their nose and inhale through it. This sequence was repeated multiple times. Total protocol duration: 6 days Total time for each exercise session: 10–15 minutes, performed twice per day Frequency: 2 times per day Group B Application Buteyko breathing technique and Virtual reality The control group will not receive any intervention after the 6-day intervention period ended, all patients underwent a re-evaluation, during which outcomes, including anxiety and sleep quality, were measured  

Description for medicine or protocol of treatment in detail：

Before collecting any data, the researcher will gain approval of all participants. this will involve explaining the study objective, procedures, and any potential risks or benefits. participants can give consent either verbally or by signing a consent form. the researcher will emphasize that participants is voluntary and that participants can pull out of the study on either time without facing any repercussions. The researcher will collect data by self-report administered measurement method. A quasi experimental design will be implemented, with three groups Participants in group A underwent Buteyko breathing technique only. Buteyko Breathing Technique Protocol(23,24) The participant took an upright position in a chair, ensuring that their shoulders were relaxed and their lower back was supported against the chair's backrest. They were instructed to execute a gentle inhalation followed by a soft exhalation. Subsequently, the participant was guided to hold their nose during the exhalation phase, maintaining a state of partial lung emptiness without excessive depletion. The duration, measured in seconds, during which the participant comfortably sustained this breath-holding until the initial urge to breathe was noted. Following the breath-holding phase, the participant was instructed to release their nose and inhale through it. This sequence was repeated multiple times. Total protocol duration: 6 days Total time for each exercise session: 10–15 minutes, performed twice per day Frequency: 2 times per day Group B Application Buteyko breathing technique and Virtual reality The control group will not receive any intervention after the 6-day intervention period ended, all patients underwent a re-evaluation, during which outcomes, including anxiety and sleep quality, were measured  

纳入标准：

including patients aged 18–65 years, learners, those undergoing surgery for the first time under general or spinal anesthesia, and those able to provide informed consent.

Inclusion criteria

including patients aged 18–65 years, learners, those undergoing surgery for the first time under general or spinal anesthesia, and those able to provide informed consent.

排除标准：

included patients with respiratory disorders that prevent slow, deep breathing, visual impairment inconsistent with virtual reality, psychiatric history, unstable cardiovascular conditions, critical illness, or low baseline anxiety scores.

Exclusion criteria：

included patients with respiratory disorders that prevent slow, deep breathing, visual impairment inconsistent with virtual reality, psychiatric history, unstable cardiovascular conditions, critical illness, or low baseline anxiety scores.

研究实施时间：

Study execute time：

从 From 2025-12-20 00:00:00至 To 2026-01-21 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-20 00:00:00 至 To 2026-01-21 00:00:00

干预措施：

Interventions：

组别：

Group A

样本量：

 31

Group：

Group A

Sample size：

干预措施：

Buteyko Breathing

干预措施代码：

Intervention：

Buteyko Breathing

Intervention code：

组别：

Group B

样本量：

 31

Group：

Group B

Sample size：

干预措施：

Buteyko Breathing+VR

干预措施代码：

Intervention：

Buteyko Breathing+VR

Intervention code：

组别：

Group C

样本量：

 31

Group：

Group C

Sample size：

干预措施：

Routine care

干预措施代码：

Intervention：

Routine care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Iraq

省(直辖市)：

 Baghdad 

市(区县)：

  

Country：

Iraq

Province：

Baghdad

City：

单位(医院)：

 Ibn al-Bitar Hospital 

单位级别：

 Tertiary 

Institution
hospital：

Ibn al-Bitar Hospital

Level of the institution：

Tertiary

国家：

 Iraq

省(直辖市)：

 Baghdad 

市(区县)：

  

Country：

Iraq

Province：

Baghdad

City：

单位(医院)：

 Ibn al-Nafis Hospital 

单位级别：

 Tertiary 

Institution
hospital：

Ibn al-Nafis Hospital

Level of the institution：

Tertiary

国家：

 Iraq

省(直辖市)：

 Baghdad 

市(区县)：

  

Country：

Iraq

Province：

Baghdad

City：

单位(医院)：

 Imam al-Hasan Hospital 

单位级别：

 Tertiary 

Institution
hospital：

Imam al-Hasan Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Sleep

指标类型：

主要指标

Outcome：

Sleep

Type：

Primary indicator

测量时间点：

1week post -intervention

测量方法：

Richards–Campbell Sleep Questionnaire for Sleep Quality

Measure time point of outcome：

1week post -intervention

Measure method：

Richards–Campbell Sleep Questionnaire for Sleep Quality

指标中文名：

Anxiety

指标类型：

主要指标

Outcome：

Anxiety

Type：

Primary indicator

测量时间点：

1week post -intervention

测量方法：

Hospital Anxiety and Depression Scale.

Measure time point of outcome：

1week post -intervention

Measure method：

Hospital Anxiety and Depression Scale.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

without

组织：

Sample Name：

without

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 65 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）：

A stratified block randomization method was used to ensure balanced allocation of participants between the intervention and control groups. Participants were first stratified according to key baseline characteristics that could influence study outcomes, such as age and gender. Within each stratum, block randomization with equal block sizes was applied to maintain an even distribution between groups throughout the recruitment process.

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

A stratified block randomization method was used to ensure balanced allocation of participants between the intervention and control groups. Participants were first stratified according to key baseline characteristics that could influence study outcomes, such as age and gender. Within each stratum, block randomization with equal block sizes was applied to maintain an even distribution between groups throughout the recruitment process.

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：

Outcome assessors and data analysts were blinded to group assignment. Participants and intervention providers were not blinded due to the nature of the behavioral interventions (Buteyko breathing and VR).

Blinding：

Outcome assessors and data analysts were blinded to group assignment. Participants and intervention providers were not blinded due to the nature of the behavioral interventions (Buteyko breathing and VR).

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）：

individual participant data will not be publicly shared to protect participant privacy, as per the ethical approval and informed consent. Aggregated results will be published in scientific journals.

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

individual participant data will not be publicly shared to protect participant privacy, as per the ethical approval and informed consent. Aggregated results will be published in scientific journals.

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：

Data will be collected using structured paper forms and later entered into an encrypted Excel database stored on a secure university server. Only the research team will have access. Data will be anonymized and backed up weekly.

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

Data will be collected using structured paper forms and later entered into an encrypted Excel database stored on a secure university server. Only the research team will have access. Data will be anonymized and backed up weekly.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-12-16 08:44:33