ChiCTR2500096696 版本V1.0 版本创建时间2025/02/05 09:07:41 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：

 ChiCTR2500096696 

最近更新日期：

Date of Last Refreshed on：

 2025-02-05 09:07:20 

注册时间：

Date of Registration：

 2025-02-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

接受产前诊断服务孕妇的社会心理支持模式研究---基于移动医疗手段的干预方法及应用

Public title：

Study on the model of psychosocial support for pregnant women receiving prenatal diagnostic services - Intervention methodology and application based on mHealth tools

注册题目简写：

English Acronym：

研究课题的正式科学名称：

接受产前诊断服务孕妇的社会心理支持模式研究---基于移动医疗手段的干预方法及应用

Scientific title：

Study on the model of psychosocial support for pregnant women receiving prenatal diagnostic services - Intervention methodology and application based on mHealth tools

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：

罗丹 

研究负责人：

罗丹 

Applicant：

Dan Luo 

Study leader：

Dan Luo 

申请注册联系人电话：

Applicant telephone：

 +86 188 7411 5987

研究负责人电话：

Study leader's
telephone：

+86 188 7411 5987

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：

 luodan_csu_2011@126.com

研究负责人电子邮件：

Study leader's E-mail：

 luodan_csu_2011@126.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：

湖南省长沙市岳麓区桐梓坡路172号中南大学湘雅公共卫生学院

研究负责人通讯地址：

湖南省长沙市岳麓区桐梓坡路172号中南大学湘雅公共卫生学院

Applicant address：

Xiangya School of Public Health, Central South University, 172 Tongzipo Road, Yuelu District, Changsha, Hunan, China

Study leader's address：

Xiangya School of Public Health, Central South University, 172 Tongzipo Road, Yuelu District, Changsha, Hunan, China

申请注册联系人邮政编码：

Applicant postcode：

 410083

研究负责人邮政编码：

Study leader's postcode：

 410083

申请人所在单位：

中南大学湘雅公共卫生学院

Applicant's institution：

Xiangya School of Public Health, Central South University

研究负责人所在单位：

中南大学湘雅公共卫生学院

Affiliation of the Leader：

Xiangya School of Public Health, Central South University

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：

 XYGW-2024-64

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：

中南大学湘雅公共卫生学院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee, Xiangya School of Public Health, Central South University, China

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-06-28 00:00:00

伦理委员会联系人：

任国峰

Contact Name of the ethic committee：

GuoFeng Ren

伦理委员会联系地址：

湖南省长沙市湘雅路110号

Contact Address of the ethic committee：

No. 110 Xiangya Road, Changsha, Hunan Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 138 7494 8266

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：

中南大学湘雅公共卫生学院

Primary sponsor：

Xiangya School of Public Health, Central South University

研究实施负责（组长）单位地址：

湖南省长沙市岳麓区桐梓坡路172号中南大学湘雅公共卫生学院

Primary sponsor's address：

Xiangya School of Public Health, Central South University, 172 Tongzipo Road, Yuelu District, Changsha, Hunan, 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)：

湖南省

市(区县)：

长沙市

Country：

China

Province：

Hunan Province

City：

ChangSha

单位(医院)：

中南大学

具体地址：

湖南省长沙市麓山南路932号

Institution
hospital：

Central South University

Address：

No. 932, Lushan South Road, Changsha, Hunan Province, China

经费或物资来源：

腾讯SSV健康普惠实验室“生机计划2023” 社会价值投资联盟（深圳）

Source(s) of funding：

Tencent SSV Health Inclusion Lab ‘Vitality Programme’ Social Value Investment Alliance (Shenzhen)

研究疾病：

接受产前诊断孕妇的情绪问题  

Target disease：

Emotional problems of pregnant women undergoing prenatal diagnosis

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

（1）开发三个可搭载移动设备实施的干预模块：①使用自助减压小程序，帮助孕妇降低心理压力；②开发家庭支持干预包，通过图片、文字、结合音频的家庭支持健康教育模块，通过指导家属利用智能手机等移动终端进行实时学习，提高家属对出生缺陷疾病的认知水平和应对技能，降低家属对遗传疾病的误解、消除可能存在的歧视态度，并在此基础上提高家属对孕妇的家庭支持水平；③采用“虚拟病人法”开发医患沟通技巧培训的新模式，指导产前诊断机构专业人员在结构化的“五习惯”沟通模式下提供遗传咨询服务、促进当地遗传咨询服务质量的提升。 （2）通过平行对照的干预研究设计，选取卫生资源不足地区的农村孕妇为目标人群，以降低孕妇在接受产前诊断过程中的心理压力水平为干预目标，测试三个干预模块的可行性、可接受性，并评估上述整合的社会心理支持干预模式对降低孕妇在产前诊断服务过程中的心理压力的初步效果，探索将移动医疗技术与妇幼健康和精神卫生服务需求相融合，促进低卫生资源地区孕妇人群的心理健康水平；并期待通过项目后期的推广与应用能为我国的人口战略提供“生机”与保障。  

Objectives of Study：

(1) Develop three intervention modules that can be implemented on mobile devices: ① Use a self-help stress reduction mini-program to help pregnant women reduce psychological stress; ② Develop a family support intervention package, which includes a family support health education module with pictures, text, and audio, to guide family members to use mobile terminals such as smartphones for real-time learning, thereby enhancing their understanding of birth defect diseases and coping skills, reducing their misunderstandings about genetic diseases, eliminating possible discriminatory attitudes, and improving their level of family support for pregnant women; ③ Adopt the "virtual patient method" to develop a new model for training medical-patient communication skills, guiding professionals in prenatal diagnosis institutions to provide genetic counseling services under a structured "five habits" communication model, and promoting the improvement of local genetic counseling service quality. (2) Through a parallel controlled intervention study design, select rural pregnant women in areas with insufficient health resources as the target population, with the goal of reducing their psychological stress levels during the prenatal diagnosis process. Test the feasibility and acceptability of the three intervention modules, and evaluate the preliminary effect of the integrated social psychological support intervention model in reducing the psychological stress of pregnant women during the prenatal diagnosis service process. Explore the integration of mobile medical technology with the health and mental health service needs of women and children to promote the mental health of pregnant women in low-health-resource areas. It is also expected that through the promotion and application in the later stage of the project, it can provide "vitality" and guarantee for China's population strategy.

药物成份或治疗方案详述：

基线调查及干预实施 确定研究样本征募开始及截止时间后（初步预计为课题现场基线启动后的三个月内），孕妇样本征募采用实时入组的方式进行。对已经入组的孕妇样本，在其完成全部的基线评估调查后即启动干预。 因为产前诊断从初诊到得到诊断结果一般是在4周以内，所以本研究将干预活动的实施时间定为1个月。 1）基线调查主要内容及方法 ①社会人口学信息 采用自编的“孕妇基本信息调查表”收集接受产前诊断服务孕妇的社会人口学信息，包括年龄、民族、文化程度、家庭年收入、家庭居住地、夫妻关系、孕期家庭结构、孕周、孕产史、现有子女情况等信息。 ②心理压力 采用由陈彰惠等人编制的妊娠压力量表(Pregnancy Pressure Scale, PPS)评估孕妇的心理压力。PPS包含30个条目，包含4个因子：因子1为认同父母角色而引发的压力感（15个条目），因子2为确保母子健康和安全而引发的压力感（8个条目），因子3为因身体外形和身体活动的改变而引发的压力感（4个条目），最后3个条目归为其他因子。采用4级评分法，“0～3”分别代表“完全没有压力”到“重度压力”。量表得分=妊娠压力实际总得分/所有条目数，因子得分=因子实际得分/条目数。计算出量表得分或因子得分，其中0分表示完全没有压力，1分以下（含1分）表示轻度压力，2分以下（含2分）表示中度压力，2分以上表示重度压力。 ③抑郁症状 采用Cox等人编制和修订的爱丁堡产后抑郁量表(Edinburgh Postnatal Depression Scale, EPDS)评估孕妇的抑郁症状。EPDS包含10个条目，采用4级评分法，“0~3”分别代表“从未”到“总是”。量表的总分范围0~30分，13分及以上为有抑郁症状，且分数越高，抑郁症状越严重。 ④焦虑症状 采用Spitzer等学者开发的广泛性焦虑量表-7(Generalized Anxiety Disorder Scale-7, GAD-7)评估接受产前诊断服务孕妇过去两周的焦虑症状。GAD-7包含7个条目，采用4级评分法，“0～3”分别代表“完全不会”到“几乎每天”。量表的总分范围0～21分，10分以上有焦虑症状，且分数越高，焦虑症状越严重。 ⑤睡眠质量 采用Buysse等人编制、刘贤臣等人修订的匹兹堡睡眠质量指数量表(Pittsburgh Sleep Quality Index, PSQI)评估接受产前诊断服务孕妇过去1个月的睡眠质量。该量表由19个自评条目和5个他评条目构成，其中第19个自评条目和5个他评条目不参与计分。18个自评条目参与计分，包括主观睡眠质量、入睡时间、睡眠时间、睡眠效率、睡眠障碍、睡眠药物、日间功能7个成分。采用4级评分法，每个成分按0～3分计分，总分为0～21分，以PSQI总分≤7分为睡眠质量好，>7分为睡眠质量差，得分越高表示睡眠质量越差。 ⑥家庭支持水平 采用Smilkstein编制的家庭关怀度指数量表(Family Adaptation Partnership Growth Affection and Resolve index, Family APGAR)评估接受产前诊断服务孕妇的家庭支持水平。该量表包含5个条目，分别涉及家庭适应度、合作度、成熟度、情感度、亲密度5个维度。采用3级评分，“0~2”分别表示“几乎很少”、“有时这样”、“经常这样”。量表的总分范围为0~10分，得分越高提示个体家庭功能越好。7~10分表示家庭功能良好，4~6分为中度障碍，0~3分为严重障碍。 2）干预实施的主要操作流程 A. 干预组 ①指导孕妇下载心理减压小程序、进行自助减压练习。 研究现场的调查员按照由课题组编制的小程序使用操作流程，指导自愿参与研究的孕妇正确使用自助减压练习小程序。从孕妇首次在医学遗传科就诊当天开始对孕妇实施为期四周的干预，孕妇需每周完成规定的任务，包括观看视频和完成音频练习。小程序内设置有任务管理器，按照提前制定的任务表，每天向用户发布任务，提醒其观看视频或进行练习，用户可以点击链接进入学习。若发现用户未按时完成任务，研究现场的调查员将与干预对象联系，提醒其使用小程序完成干预。 ②实施家庭支持干预方案： 孕妇的配偶和共同居住的父母辈家人（以下简称为核心家庭成员），在调查员的指导下，下载家庭支持干预小程序，学习并开展家庭辅导。孕妇家人也被建议同样下载减压小程序，并进行练习。家庭核心成员的干预时间共4周。由经过统一培训的调查员开展为期四周的家庭辅导，指导与孕妇共同居住核心家庭成员通过微信或QQ给孕妇及其家庭核心成员在接受产前诊断前、等待结果期间、获知结果后三个阶段发放家庭支持辅导视频和音频，并定期督促其观看。 ③孕妇进行产前诊断的全过程中、专业人员采用“五习惯”沟通法进行沟通。 B.对照组 对照组现场的孕妇维持其常规的诊疗和临床服务流程及内容，对孕妇及其家属、以及该机构的遗传咨询专业人员不实施任何干预。 3）伦理学考虑 在调查前，研究现场的调查员须向研究对象解释清楚研究目的和研究内容，在取得研究对象知情同意后方可开始调查。调查过程中严格遵守隐私保护规定，对研究对象的个人信息严格保密。在干预组完成干预和评估后，在对照组的现场，将根据参与者的知情同意和需求状况，对对照组所在的机构的遗传咨询专业人员、孕妇本人及家属同样的给与整合的社会心理支持干预，确保所有研究参与者的获益。 （3）干预效果评价研究 在干预实施1个月后，对干预组和对照组的研究对象的心理压力、抑郁和焦虑情绪症状、睡眠质量和家庭支持采用完全一致的评价工具和指标进行评估调查，具体评估内容及方法参见基线研究部分。为能观察到干预实施的延时反应，在干预实施2个月后，再开始一次评估调查，所有调查工具和指标均与之前相同。评估调查结束后，通过统计分析，对比干预组和对照组各项评估结果的数据，得到科学的评价结论。 

Description for medicine or protocol of treatment in detail：

Baseline investigation and intervention implementation After the start and end time of study sample recruitment was determined (the initial estimate was within three months after the start of the subject field baseline), the pregnant women sample recruitment was carried out by real-time enrollment. The intervention was initiated in the enrolled sample of pregnant women after they completed all baseline assessment surveys. Since prenatal diagnosis usually takes less than 4 weeks from the first diagnosis to the diagnosis result, the implementation time of intervention activities was set at 1 month in this study. 1) Main contents and methods of baseline survey ① Sociodemographic information The social demographic information of pregnant women receiving prenatal diagnosis services was collected using the self-designed "Basic Information Questionnaire for Pregnant women", including age, nationality, education level, annual family income, family residence, marital relationship, family structure during pregnancy, gestational week, gestational history, and existing children. ② Psychological pressure The Pregnancy Pressure Scale (PPS) developed by Chen Changhui et al. was used to evaluate the psychological stress of pregnant women. PPS contains 30 entries, which contain 4 factors: Factor 1 for feelings of stress arising from identifying with the role of parent (15 entries), Factor 2 for feelings of stress arising from changes in physical appearance and physical activity (8 entries), Factor 3 for feelings of stress arising from changes in physical appearance and physical activity (4 entries), and the last 3 entries are classified as other factors. A 4-point scale was used, with "0 to 3" representing "no stress at all" to "severe stress." Scale score = actual total score of pregnancy stress/number of items, factor score = actual score of factor/number of items. The scale score or factor score is calculated, where 0 indicates no stress at all, less than 1 (including 1) indicates mild stress, less than 2 (including 2) indicates moderate stress, and more than 2 indicates severe stress. ③ Depressive symptoms The Edinburgh Postnatal Depression Scale (EPDS) developed and revised by Cox et al. was used to assess the depressive symptoms of pregnant women. The EPDS consists of 10 entries and uses a 4-level scoring system, with "0 to 3" representing "never" to "always." The total score of the scale ranges from 0 to 30 points, with 13 points and above indicating depressive symptoms, and the higher the score, the more serious the depressive symptoms. ④ Anxiety symptoms Generalized Anxiety Disorder Scale-7 (GAD-7), developed by Spitzer et al., was used to assess anxiety symptoms during the past two weeks in pregnant women receiving prenatal diagnosis services. GAD-7 consists of seven entries and is graded on a 4-point scale, with "0 to 3" representing "not at all" to "almost every day." The total score of the scale ranges from 0 to 21 points, and more than 10 points have anxiety symptoms, and the higher the score, the more serious the anxiety symptoms. ⑤ Sleep quality The Pittsburgh Sleep Quality Index (PSQI) compiled by Buysse et al., and revised by Liu Xianchen et al., was used to assess the sleep quality of pregnant women who received prenatal diagnosis services in the past 1 month. The scale consists of 19 self-rated items and 5 other rated items, among which the 19th self-rated item and 5 other rated items do not participate in the score. 18 self-evaluation items were scored, including 7 components: subjective sleep quality, sleep time, sleep time, sleep efficiency, sleep disorders, sleep drugs and daytime function. The 4-level scoring method was adopted, and each component was scored according to 0 ~ 3 points, with a total score of 0 ~ 21 points. PSQI total score ≤7 was classified as good sleep quality, and PSQI total score >7 was classified as poor sleep quality. The higher the score, the worse the sleep quality. ⑥ Level of family support The Family Adaptation Partnership Growth Affection and Resolve index compiled by Smilkstein was adopted. Family APGAR assesses the level of family support in pregnant women receiving antenatal diagnostic services. The scale contains 5 items, which are related to 5 dimensions of family fitness, cooperation, maturity, emotion and intimacy. A 3-level score is used, with "0 to 2" indicating "almost rarely," "sometimes," and "often." The total score of the scale ranges from 0 to 10 points, the higher the score indicates that the individual family function is better. A score of 7 to 10 indicates good family functioning, 4 to 6 is moderately impaired, and 0 to 3 is severely impaired.2) Main operation process of intervention implementation A. Intervention group ① Guide pregnant women to download psychological decompression small program and carry out self-help decompression exercises. The investigators at the study site guided the pregnant women who volunteered to participate in the study to correctly use the self-stress reduction exercise mini program according to the operation procedure prepared by the research group. The intervention lasted for four weeks, starting on the day of the first visit to the medical genetics department, and the pregnant women were required to complete prescribed tasks each week, including watching videos and completing audio exercises. The mini program is equipped with a task manager, which releases tasks to users every day according to the task list formulated in advance, reminding them to watch videos or practice, and users can click the link to enter the study. If it is found that the user does not complete the task on time, the investigator at the study site will contact the intervention subject and remind them to use the small program to complete the intervention. ② Implementation of family support intervention programs: Pregnant women's spouses and co-living parents (hereinafter referred to as nuclear family members), under the guidance of the investigator, download the family support intervention program, learn and carry out family counseling. Families of pregnant women are also advised to download and practice the same stress-reduction mini program. The intervention time of the family core members was 4 weeks. Family counseling was conducted for a period of four weeks by uniformly trained investigators, and the nuclear family members living with pregnant women were instructed to send video and audio family support counseling to pregnant women and their family core members through wechat or QQ during the three stages before receiving prenatal diagnosis, waiting for the result, and after receiving the result, and regularly urged to watch it. ③ During the whole process of prenatal diagnosis of pregnant women, professionals use the "five habits" communication method to communicate. B. Control group The pregnant women in the control group maintained their usual procedures and contents of diagnosis and clinical services, and no intervention was performed on the pregnant women, their families, or the genetic counseling professionals of the institution. 3) Ethical considerations Before the investigation, the investigators at the research site must explain clearly the purpose and content of the research to the research subjects, and can only start the investigation after obtaining the informed consent of the research subjects. During the investigation, the privacy protection regulations were strictly observed, and the personal information of the research subjects was strictly kept confidential. After the intervention group completes the intervention and assessment, the genetic counseling professionals of the institution where the control group is located, the pregnant women themselves and their families will also be given integrated psychosocial support interventions at the site of the control group according to the informed consent and needs of the participants, so as to ensure the benefits of all study participants. (3) Evaluation of intervention effect One month after the implementation of the intervention, the psychological stress, depression and anxiety symptoms, sleep quality and family support of the study subjects in the intervention group and the control group were evaluated using identical evaluation tools and indicators. For specific assessment contents and methods, refer to the baseline study. In order to observe the delayed response to the intervention, an evaluation survey was conducted 2 months after the intervention with the same survey tools and indicators. After the evaluation survey, through statistical analysis, comparison of the intervention group and the control group of the evaluation results of the data, to get a scientific evaluation conclusion. 

纳入标准：

①户籍为农村的接受产前诊断服务的孕妇； ②超声提示胎儿患有非严重致残或致死的结构畸形； ③年龄≥18周岁； ④孕16~32周； ⑤孕妇和配偶均会使用可联网的移动通信设备。

Inclusion criteria

1. Pregnant women with rural household registration who receive prenatal diagnosis services; 2. Ultrasound indicates that the fetus has non-severe disabling or fatal structural malformations; 3. Age >= 18 years old; 4. 16 to 32 weeks of pregnancy; 5. Both the pregnant woman and her spouse can use mobile communication devices with internet access.

排除标准：

①患有严重精神疾病、或其他严重躯体疾病者不宜参与干预研究； ②因认知能力受限、不能独立完成在线问卷调查和使用自助减压练习小程序； ③基线调查时压力评分为0分的孕妇。

Exclusion criteria：

1. Individuals with severe mental illnesses or other serious physical health conditions should not participate in intervention studies. 2. Those with limited cognitive abilities who cannot independently complete online surveys or use self-help stress reduction applications. 3. Pregnant women who have a stress score of 0 during baseline surveys.

研究实施时间：

Study execute time：

从 From 2024-06-01 00:00:00至 To 2025-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-02-10 00:00:00 至 To 2025-05-10 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 68

Group：

Intervention group

Sample size：

干预措施：

指导孕妇下载课题组编制的心理减压小程序、进行自助减压练习。核心家庭成员下载家庭支持干预小程序，学习并开展家庭辅导。

干预措施代码：

Intervention：

Pregnant women were instructed to download the psychological stress reduction applet developed by the project team and conduct self-help stress reduction exercises. Core family members downloaded the Family Support Intervention Applet to learn and conduct family counselling. At the prenatal diagnostic centre selected as the site for the intervention, a mobile-based virtual patient app was used to train all doctors providing genetic counselling at the centre in the ‘five habits’ of doctor-patient communication.

Intervention code：

组别：

对照组

样本量：

 68

Group：

control group

Sample size：

干预措施：

对照组现场的孕妇维持其常规的诊疗和临床服务流程及内容，对孕妇及其家属、以及该机构的遗传咨询专业人员不实施任何干预。

干预措施代码：

Intervention：

Pregnant women at the control site maintained their routine diagnostic and clinical service processes and content, and no interventions were implemented for pregnant women, their families, or the genetic counselling professionals at the facility.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

 长沙市 

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

 湖南省妇幼保健院 

单位级别：

 三甲 

Institution
hospital：

Hunan Maternal and Child Health Centre

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

 长沙市 

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

 长沙市妇幼保健院 

单位级别：

 三甲 

Institution
hospital：

Changsha Maternal and Child Health Centre

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

 怀化 

Country：

China

Province：

Hunan

City：

HuaiHua

单位(医院)：

 怀化市妇幼保健院 

单位级别：

 三级 

Institution
hospital：

Huaihua Maternal and Child Health Centre

Level of the institution：

Tertiary

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

 永州市 

Country：

China

Province：

Hunan

City：

Yongzhou

单位(医院)：

 永州市妇幼保健院 

单位级别：

 三级 

Institution
hospital：

Yongzhou Maternal and Child Health Centre

Level of the institution：

Tertiary

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

 吉首市 

Country：

China

Province：

Hunan

City：

Jishou

单位(医院)：

 湘西土家族苗族自治州人民医院 

单位级别：

 三甲 

Institution
hospital：

Xiangxi Tujia and Miao Autonomous Prefecture People's Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

 邵阳市 

Country：

China

Province：

Hunan

City：

Shaoyang

单位(医院)：

 邵阳学院附属第一医院 

单位级别：

 三甲 

Institution
hospital：

The First Hospital Affiliated to Shaoyang College

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

 邵阳市 

Country：

China

Province：

Hunan

City：

Shaoyang

单位(医院)：

 邵阳市妇幼保健院 

单位级别：

 二甲 

Institution
hospital：

Shaoyang Maternal and Child Health Centre

Level of the institution：

Secondary A

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

 张家界市 

Country：

China

Province：

Hunan

City：

Zhangjiajie

单位(医院)：

 张家界永定区妇幼保健院 

单位级别：

 二甲 

Institution
hospital：

Zhangjiajie Yongding District Maternal and Child Health Centre

Level of the institution：

Secondary A

测量指标：

Outcomes：

指标中文名：

心理压力

指标类型：

主要指标

Outcome：

psychological pressure

Type：

Primary indicator

测量时间点：

干预前后

测量方法：

妊娠压力量表

Measure time point of outcome：

before and after the intervention

Measure method：

Pregnancy Pressure Scale, PPS

指标中文名：

抑郁症状

指标类型：

主要指标

Outcome：

depressive symptom

Type：

Primary indicator

测量时间点：

干预前后

测量方法：

爱丁堡产后抑郁量表

Measure time point of outcome：

before and after the intervention

Measure method：

Edinburgh Postnatal Depression Scale, EPDS

指标中文名：

焦虑症状

指标类型：

主要指标

Outcome：

Anxiety

Type：

Primary indicator

测量时间点：

干预前后

测量方法：

广泛性焦虑量表-7

Measure time point of outcome：

before and after the intervention

Measure method：

Generalized Anxiety Disorder Scale-7, GAD-7

指标中文名：

睡眠质量

指标类型：

主要指标

Outcome：

Quality of sleep

Type：

Primary indicator

测量时间点：

干预前后

测量方法：

匹兹堡睡眠质量指数量表

Measure time point of outcome：

before and after the intervention

Measure method：

Pittsburgh Sleep Quality Index, PSQI

指标中文名：

家庭支持水平

指标类型：

主要指标

Outcome：

Level of family support

Type：

Primary indicator

测量时间点：

干预前后

测量方法：

家庭关怀度指数量表

Measure time point of outcome：

before and after the intervention

Measure method：

Family Adaptation Partnership Growth Affection and Resolve index, Family APGAR

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

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 75 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）：

先在湖南省妇幼保健院和长沙市妇幼保健院进行预实验，后期由一名不参与课题的现场工作人员利用简单随机法，将其余六家诊断机构中备选的两家诊断中心随机编入对照组和干预组。

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

A pre-experiment was first conducted at the Provincial Maternal and Child Health Hospital and the Changsha Maternal and Child Health Hospital, and at a later stage two alternative diagnostic centres out of the six diagnostic institutions were randomly assigned to the control group and the intervention group using simple randomisation by a fieldworker who was not involved in the subject matter.

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：

无

Blinding：

none

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）：

无

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

none

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：

无

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

none

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：

  2025-02-05 09:07:20