ChiCTR-TRC-11001657 版本V1.0 版本创建时间2015/07/22 13:14:42 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：

 ChiCTR-TRC-11001657 

最近更新日期：

Date of Last Refreshed on：

 2015-05-05 14:41:00 

注册时间：

Date of Registration：

 2011-11-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Music therapy on pain and stress reduction during transvaginal ultrasound-guided oocyte retrieval: a randomized controlled trial

Public title：

Music therapy on pain and stress reduction during transvaginal ultrasound-guided oocyte retrieval: a randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Music therapy on pain and stress reduction during transvaginal ultrasound-guided oocyte retrieval: a randomized controlled trial

Scientific title：

Music therapy on pain and stress reduction during transvaginal ultrasound-guided oocyte retrieval: 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：

CUHK_CCT00300

申请注册联系人：

Carol Chan 

研究负责人：

Dr. Wai Yee Wong 

Applicant：

Carol Chan 

Study leader：

Dr. Wai Yee Wong 

申请注册联系人电话：

Applicant telephone：

 +852 26321764

研究负责人电话：

Study leader's
telephone：

+852 26322583

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：

 carolchan@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 alicewywong@cuhk.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：

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

研究负责人通讯地址：

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

Applicant address：

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

Study leader's address：

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

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：

Prince of Wales Hospital, The Chinese University of Hong Kong

Applicant's institution：

Prince of Wales Hospital, The Chinese University of Hong Kong

研究负责人所在单位：

Affiliation of the Leader：

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：

 NA

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Prince of Wales Hospital

Name of the ethic committee：

Prince of Wales Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2011-08-29 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

Prince of Wales Hospital, The Chinese University of Hong Kong

Primary sponsor：

Prince of Wales Hospital, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

Primary sponsor's address：

1/F, Block F, Department of Obstetrics &Gynaecology, Prince of Wales Hospital

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

Source(s) of funding：

Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong

研究疾病：

infertile women undergoing oocyte retrieval  

Target disease：

infertile women undergoing oocyte retrieval

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：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

Music therapy on pain and stress reduction during transvaginal ultrasound-guided oocyte retrieval: a randomized controlled trial  

Objectives of Study：

Music therapy on pain and stress reduction during transvaginal ultrasound-guided oocyte retrieval: a randomized controlled trial

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Patient undergoing transvaginal ultrasound-guided oocyte retrieval

Inclusion criteria

Patient undergoing transvaginal ultrasound-guided oocyte retrieval

排除标准：

1. Patient is suffering from following disease i)Deaf ii)Endocrine disease including diabetes mellitus, thyroid, hypothalamic, adrenal problems iii)On steroid therapy iv)Salivary gland disease 2. Smoker or drinker 3. Refuse or incompetence for informed consent

Exclusion criteria：

1. Patient is suffering from following disease i)Deaf ii)Endocrine disease including diabetes mellitus, thyroid, hypothalamic, adrenal problems iii)On steroid therapy iv)Salivary gland disease 2. Smoker or drinker 3. Refuse or incompetence for informed consent

研究实施时间：

Study execute time：

从 From 2011-10-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2011-10-01 00:00:00 至 To 2012-11-04 00:00:00

干预措施：

Interventions：

组别：

A

样本量：

 0

Group：

A

Sample size：

干预措施：

One group of patient will be offered a MP3 machine with headphone, however, no music will be played.

干预措施代码：

Intervention：

One group of patient will be offered a MP3 machine with headphone, however, no music will be played.

Intervention code：

组别：

B

样本量：

 0

Group：

B

Sample size：

干预措施：

In another group, no MP3 machine with headphone and no music will be offered.

干预措施代码：

Intervention：

In another group, no MP3 machine with headphone and no music will be offered.

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

City：

单位(医院)：

 Prince of Wales Hospital 

单位级别：

 Prince of Wales Hospital 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Prince of Wales Hospital

测量指标：

Outcomes：

指标中文名：

Assessment of pain by a 100mm linear visual analogous scale (VAS) related to transvaginal ultrasound-guided oocyte retrieval (TUGOR). Patient will be asked to give the satisfaction score regarding the pain control of TUGOR.

指标类型：

主要指标

Outcome：

Assessment of pain by a 100mm linear visual analogous scale (VAS) related to transvaginal ultrasound-guided oocyte retrieval (TUGOR). Patient will be asked to give the satisfaction score regarding the pain control of TUGOR.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Surgeon’s perception towards adequately of pain and sedation control will be rated using same VAS and satisfactory score.

指标类型：

次要指标

Outcome：

Surgeon’s perception towards adequately of pain and sedation control will be rated using same VAS and satisfactory score.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

The additional of analgesic during and after TUGOR will be recorded.

指标类型：

主要指标

Outcome：

The additional of analgesic during and after TUGOR will be recorded.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Blood pressure, heart rate, respiratory rate, oxygen saturation level will be measured in every 10 minutes during TUGOR.

指标类型：

主要指标

Outcome：

Blood pressure, heart rate, respiratory rate, oxygen saturation level will be measured in every 10 minutes during TUGOR.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Assessment of anxiety and stress Basal anxiety level will be assessed by the Chinese version of the Spielberger’s State Anxiety Inventory (STAI) (Appendix I)

指标类型：

主要指标

Outcome：

Assessment of anxiety and stress Basal anxiety level will be assessed by the Chinese version of the Spielberger’s State Anxiety Inventory (STAI) (Appendix I)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

12-item General Health Questionnaire (GHQ-12) (Appendix II) and Beck Depression Inventory (BDI) (Appendix III)

指标类型：

主要指标

Outcome：

12-item General Health Questionnaire (GHQ-12) (Appendix II) and Beck Depression Inventory (BDI) (Appendix III)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Salivary for stress hormone including cortisol and amylase level will be measured before and immediately after TUGOR procedures.

指标类型：

主要指标

Outcome：

Salivary for stress hormone including cortisol and amylase level will be measured before and immediately after TUGOR procedures.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Assessment of patient satisfaction Patient attitude towards the treatment will be assessed by an 8-item client satisfaction questionnaire (CSQ-8) (Appendix IV).

指标类型：

次要指标

Outcome：

Assessment of patient satisfaction Patient attitude towards the treatment will be assessed by an 8-item client satisfaction questionnaire (CSQ-8) (Appendix IV).

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Experience of post-operative side effect will be recorded.

指标类型：

次要指标

Outcome：

Experience of post-operative side effect will be recorded.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Sedation and co-operation scale intra-operative sedation and co-operation will be assessed by surgeon of TUGOR and will be scored according to 5-point sedation and co-operation scales.

指标类型：

次要指标

Outcome：

Sedation and co-operation scale intra-operative sedation and co-operation will be assessed by surgeon of TUGOR and will be scored according to 5-point sedation and co-operation scales.

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：

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 45 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

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

randomization

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 label

Blinding：

Open label

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

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）：

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

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

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2011-11-04 00:00:00