ChiCTR2200059463 版本V1.0 版本创建时间2023/02/12 15:18:50 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：

 ChiCTR2200059463 

最近更新日期：

Date of Last Refreshed on：

 2022-04-30 06:13:26 

注册时间：

Date of Registration：

 2022-04-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

森林浴對香港患有高血壓的中年人在降低血壓，心率，和焦慮水平以及促進積極情 緒的成效

Public title：

The Effectiveness of Forest Bathing on Lowering Blood Pressure, Heart Rate, and Anxiety Levels and Promoting a Positive Mood among Hypertensive Middle-aged Adults in Hong Kong

注册题目简写：

English Acronym：

研究课题的正式科学名称：

森林浴對香港患有高血壓的中年人在降低血壓，心率，和焦慮水平以及促進積極情 緒的成效

Scientific title：

The Effectiveness of Forest Bathing on Lowering Blood Pressure, Heart Rate, and Anxiety Levels and Promoting a Positive Mood among Hypertensive Middle-aged Adults in Hong Kong

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：

邱嘉燕博士 

研究负责人：

邱嘉燕博士 

Applicant：

Dr. Yau Ka Yin 

Study leader：

Dr. Yau Ka Yin 

申请注册联系人电话：

Applicant telephone：

 +852 3190 6689

研究负责人电话：

Study leader's
telephone：

+852 3190 6689

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：

 kyyau@twc.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 kyyau@twc.edu.hk

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：

香港何文田衛理道31號馬錦燦紀念大樓

研究负责人通讯地址：

香港何文田衛理道31號馬錦燦紀念大樓

Applicant address：

Ma Kam Chan Memorial Building, 31 Wylie Road, Homantin, Hong Kong, China

Study leader's address：

Ma Kam Chan Memorial Building, 31 Wylie Road, Homantin, Hong Kong, Cina

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：

東華學院護理學院

Applicant's institution：

School of Nursing, Tung Wah College

研究负责人所在单位：

東華學院護理學院

Affiliation of the Leader：

School of Nursing, Tung Wah College

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：

 REC2021113

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：

東華學院研究倫理委員會

Name of the ethic committee：

Research ethic committee, Tung Wah College

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-02-01 00:00:00

伦理委员会联系人：

Dr. David Wong

Contact Name of the ethic committee：

Dr. David Wong

伦理委员会联系地址：

研究事務處: 香港旺角山東街90號A鍾江海紀念大樓4樓

Contact Address of the ethic committee：

Research office : 4/F Cheung Kung Hai Memorial Building, 90A Shantung Street, Mongkok, Kowloon, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3190 6722

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 ro@twc.edu.hk

研究实施负责（组长）单位：

東華學院護理學院

Primary sponsor：

School of Nursing, Tung Wah College

研究实施负责（组长）单位地址：

香港何文田衛理道31號馬錦燦紀念大樓

Primary sponsor's address：

Ma Kam Chan Memorial Building, 31 Wylie Road, Homantin, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

醫療衛生研究基金

Source(s) of funding：

Health and Medical Research Fund

研究疾病：

高血壓  

Target disease：

Hypertension

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：

随机抽样 

Study design：

Randomly Sampling 

研究目的：

Our proposed study aims to promote cardiac and mental health on hypertensive middle-aged adults through Forest bathing (FB) and diaphragmatic deep breathing exercise (DDBE). Objectives: 1. Examine and compare the effects of a four-week period of FB, DDBE and usual care on SBP, DBP, HRV, state and trait anxiety level, and mood status of participants over the 4 weeks of intervention. 2. Examine and compare the sustained effect of FB, DDBE and usual care on SBP, DBP, HRV, state and trait anxiety level, and mood status of participants at 8 weeks after the 4-week of intervention.  

Objectives of Study：

Our proposed study aims to promote cardiac and mental health on hypertensive middle-aged adults through Forest bathing (FB) and diaphragmatic deep breathing exercise (DDBE). Objectives: 1. Examine and compare the effects of a four-week period of FB, DDBE and usual care on SBP, DBP, HRV, state and trait anxiety level, and mood status of participants over the 4 weeks of intervention. 2. Examine and compare the sustained effect of FB, DDBE and usual care on SBP, DBP, HRV, state and trait anxiety level, and mood status of participants at 8 weeks after the 4-week of 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：

The study will be conducted among hypertensive middle-aged community dwellers. The inclusion criteria for recruitment are:
(1) men or women aged between 45 and 64 years;
(2) living in Hong Kong and able to read Chinese and understand Cantonese;
(3) SBP consistently ranging from 130-159 mmHg and/or DBP ranged from 80-99 mmHg; with or without doctor-diagnosed hypertension and
(4) with and without hypertensive drug;
(5) have not received relaxation therapies during the past two months.

Inclusion criteria

The study will be conducted among hypertensive middle-aged community dwellers. The inclusion criteria for recruitment are:
(1) men or women aged between 45 and 64 years;
(2) living in Hong Kong and able to read Chinese and understand Cantonese;
(3) SBP consistently ranging from 130-159 mmHg and/or DBP ranged from 80-99 mmHg; with or without doctor-diagnosed hypertension and
(4) with and without hypertensive drug;
(5) have not received relaxation therapies during the past two months.

排除标准：

The inclusion in the intervention of participants with extremely high SBP, above 159 mmHg, is considered inappropriate, and they are advised to seek medical care. Those who are pregnant or experiencing chronic pain and muscle weakness, unable to walk independently, or diagnosed with coronary heart disease, stroke, carcinoma, or known mental disorders such as delusions and depression; and undergoing psychotherapy will also be excluded.

Exclusion criteria：

The inclusion in the intervention of participants with extremely high SBP, above 159 mmHg, is considered inappropriate, and they are advised to seek medical care. Those who are pregnant or experiencing chronic pain and muscle weakness, unable to walk independently, or diagnosed with coronary heart disease, stroke, carcinoma, or known mental disorders such as delusions and depression; and undergoing psychotherapy will also be excluded.

研究实施时间：

Study execute time：

从 From 2022-05-01 00:00:00至 To 2023-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-06-01 00:00:00 至 To 2023-09-01 00:00:00

干预措施：

Interventions：

组别：

1组

样本量：

 297

Group：

Group 1

Sample size：

干预措施：

Forest bathing

干预措施代码：

Intervention：

Forest bathing

Intervention code：

组别：

2组

样本量：

 297

Group：

Group 2

Sample size：

干预措施：

Diaphragmatic deep breathing exercise

干预措施代码：

Intervention：

Diaphragmatic deep breathing exercise

Intervention code：

组别：

3组

样本量：

 297

Group：

Group 3

Sample size：

干预措施：

Usual care

干预措施代码：

Intervention：

Usual care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Community Health Centers 

单位级别：

  

Institution
hospital：

Community Health Centers

Level of the institution：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Non-governmental organization 

单位级别：

  

Institution
hospital：

Non-governmental organization

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Systolic Blood Pressure

指标类型：

主要指标

Outcome：

Systolic Blood Pressure

Type：

Primary indicator

测量时间点：

测量方法：

using a validated portable digital sphygmomanometer

Measure time point of outcome：

Measure method：

using a validated portable digital sphygmomanometer

指标中文名：

Diastolic blood pressure

指标类型：

次要指标

Outcome：

Diastolic blood pressure

Type：

Secondary indicator

测量时间点：

测量方法：

using a validated portable digital sphygmomanometer

Measure time point of outcome：

Measure method：

using a validated portable digital sphygmomanometer

指标中文名：

Heart rate variability

指标类型：

次要指标

Outcome：

Heart rate variability

Type：

Secondary indicator

测量时间点：

测量方法：

using heart rate senor

Measure time point of outcome：

Measure method：

using heart rate senor

指标中文名：

anxiety level

指标类型：

次要指标

Outcome：

anxiety level

Type：

Secondary indicator

测量时间点：

测量方法：

Chinese version of State and Trait Anxiety Inventory (STAI) questionnaire

Measure time point of outcome：

Measure method：

Chinese version of State and Trait Anxiety Inventory (STAI) questionnaire

指标中文名：

mood states

指标类型：

次要指标

Outcome：

mood states

Type：

Secondary indicator

测量时间点：

测量方法：

Chinese version of The Profile of Mood States Short Form (POMS-SF) questionnaire

Measure time point of outcome：

Measure method：

Chinese version of The Profile of Mood States Short Form (POMS-SF) questionnaire

采集人体标本：

Collecting sample(s)
from participants：

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 45 岁 years
最大 Max age 64 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

The applicants will generates the random number by a true random number generator

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

The applicants will generates the random number by a true random number generator

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：

Open

Blinding：

Open

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）：

https://www.chictr.org.cn/

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

https://www.chictr.org.cn/

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：

Case record form and an electronic data capture will be used for data collection and record.

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

Case record form and an electronic data capture will be used for data collection and record.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-04-30 06:13:26