ChiCTR2500107854 版本V1.0 版本创建时间2025/08/20 09:05:22 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：

ChiCTR2500107854 

最近更新日期：

Date of Last Refreshed on：

2025-08-20 09:05:18 

注册时间：

Date of Registration：

2025-08-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于人际关系理论的垂体腺瘤患者术后心理困扰干预方案的构建及应用

Public title：

Construction and application of postoperative psychological distress intervention Program for patients with pituitary adenoma based on interpersonal relationship Theory

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于人际关系理论的垂体腺瘤患者术后心理困扰干预方案的构建及应用

Scientific title：

Construction and application of postoperative psychological distress intervention Program for patients with pituitary adenoma based on interpersonal relationship Theory

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：

张腊婷 

研究负责人：

姜雪 

Applicant：

Lating Zhang 

Study leader：

Xue Jiang 

申请注册联系人电话：

Applicant telephone：

+86 132 2359 0211

研究负责人电话：

Study leader's telephone：

+86 137 0022 6391

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：

1186812699@qq.com

研究负责人电子邮件：

Study leader's E-mail：

jiangxue6391@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：

西安市灞桥区新寺路569号唐都医院

研究负责人通讯地址：

西安市灞桥区新寺路569号唐都医院

Applicant address：

Tangdu Hospital, No. 569, Xinsi Road, Baqiao District, Xi 'an City

Study leader's address：

Tangdu Hospital, No. 569, Xinsi Road, Baqiao District, Xi 'an City

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：

第四军医大学唐都医院

Applicant's institution：

Tangdu Hospital, Fourth Military Medical University

研究负责人所在单位：

第四军医大学唐都医院

Affiliation of the Leader：

Tangdu Hospital, Fourth Military Medical University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

第202506-06号

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：

第四军医大学唐都医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Tangdu Hospital, Fourth Military Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-06-06 00:00:00

伦理委员会联系人：

李诗草

Contact Name of the ethic committee：

Shicao Li

伦理委员会联系地址：

西安市灞桥区新寺路569号唐都医院

Contact Address of the ethic committee：

Tangdu Hospital, No. 569, Xinsi Road, Baqiao District, Xi 'an City

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 29 8471 7761

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：

第四军医大学唐都医院

Primary sponsor：

Tangdu Hospital, Fourth Military Medical University

研究实施负责（组长）单位地址：

西安市灞桥区新寺路569号唐都医院

Primary sponsor's address：

Tangdu Hospital, No. 569, Xinsi Road, Baqiao District, Xi 'an City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

陕西省

市(区县)：

Country：

China

Province：

Shanxi

City：

单位(医院)：

第四军医大学唐都医院

具体地址：

西安市灞桥区新寺路569号唐都医院

Institution
hospital：

cTangdu Hospital, Fourth Military Medical Universitc

Address：

Tangdu Hospital, No. 569, Xinsi Road, Baqiao District, Xi 'an City

经费或物资来源：

无

Source(s) of funding：

No funding

Target disease：

pituitary adenoma

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：

构建基于人际关系理论的垂体腺瘤患者术后心理困扰的干预方案，并应用以探讨干预方案的有效性  

Objectives of Study：

To construct an intervention plan for postoperative psychological distress of patients with pituitary adenoma based on interpersonal relationship theory and apply it to explore the effectiveness of the intervention plan

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

经影像学、内分泌学检查，符合《中国难治性垂体腺瘤诊治专家共识（2019）》诊断标准，确诊为脑垂体瘤； 年龄18~65岁者； 符合手术条件并接受手术的患者； 临床病例资料完整； 经知情同意并自愿参与本研究。

Inclusion criteria

After imaging and endocrinological examinations, it met the diagnostic criteria of the "Expert Consensus on the Diagnosis and Treatment of Refractory Pituitary Adenoma in China (2019)", and was diagnosed as a pituitary adenoma. Those aged 18 to 65; Patients who meet the surgical conditions and undergo surgery; The clinical case data are complete. With informed consent and voluntary participation in this study.

排除标准：

有凝血功能障碍的患者； 有精神疾病病史者； 有言语及听力障碍、智力与情感障碍、认知功能障者； 合并其他严重器质性疾病; 伴有血液传染疾病者； 术前参与其他药物治疗研究者； 肝、肾等重要器官功能不全者。

Exclusion criteria：

Patients with coagulation disorders; Those with a history of mental illness; Those with speech and hearing impairments, intellectual and emotional impairments, and cognitive impairments; Combined with other serious organic diseases; Those with blood-borne infectious diseases; Researchers who participated in other drug treatments before the operation; People with impaired functions of vital organs such as the liver and kidneys.

研究实施时间：

Study execute time：

从 From 2025-09-01 00:00:00至 To 2026-03-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-09-01 00:00:00 至 To 2026-03-01 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

53

Group：

intervention group

Sample size：

干预措施：

认识期：建立良好护患关系；评估患者的基本情况；介绍心理困扰及反刍思维；获得患者对干预目标及内容的认可，提高依从性。 确认期：评估患者心理困扰、社会支持、自我效能及反刍思维情况；帮助患者了解自己，为制定计划做准备。 进展期：鼓励患者表达自己的需求和恐惧复发的信息,帮助患者积极应对缓解其复发恐惧。 帮助患者识别并缓解内心负面情绪；认识导致自身产生负性情绪的原因，尝试事件重评并积极解决问题。帮助患者发掘自身优势，学会利用自身资源，改善身体与认知问题。学会积极自我暗示，能够看到他人优点，关注事情的积极面；恢复社会功能。发现自身优点，挖掘自己的积极资源；帮助患者改善性功能问题并学会与痛苦相处，接纳自我。 解决期：回顾全程，总结收获，找到未来生活的意义。

干预措施代码：

Intervention：

Recognition phase: Establish a good nurse-patient relationship; assess the patient's basic condition; introduce psychological distress and rumination; obtain the patient's acceptance of the intervention goals and content to improve compliance. Confirmation phase: Assess the patient's psychological distress, social support, self-efficacy, and rumination; help the patient understand themselves and prepare for plan development. Progression Phase: Encourage patients to express their needs and fears of relapse; assist patients in actively addressing and alleviating their fears of relapse. Help patients identify and alleviate negative emotions; recognize the causes of negative emotions, attempt to reevaluate events, and actively resolve issues. Assist patients in discovering their strengths, learning to utilize their own resources, and improving physical and cognitive issues. Learn positive self-suggestion, recognize others' strengths, and focus on the positive aspects of situations; restore social functioning. Discover personal strengths and tap into positive resources; assist patients in addressing sexual dysfunction and learning to cope with pain, while fostering self-acceptance. Resolution phase: Reflect on the entire process, summarize gains, and identify the meaning of future life.

Intervention code：

组别：

对照组

样本量：

53

Group：

control group

Sample size：

干预措施：

患者给予常规临床护理，入院后收集患者一般资料、评估患者，建立治疗护理档案，进行病情监测、健康宣教等；出院后，研究者于干预后即刻，干预后3个月对患者进行微信随访。随访内容结构化，主要包括询问患者近期身体情况，了解患者可能存在的不良情绪等，并邀请其填写调查问卷。

干预措施代码：

Intervention：

Patients received routine clinical care. Upon admission, general patient information was collected, patients were assessed, treatment and nursing records were established, and condition monitoring and health education were conducted. After discharge, the researchers conducted follow-up visits via WeChat immediately after the intervention and again three months after the intervention. The follow-up visits were structured and mainly included inquiring about the patient's recent physical condition, understanding any negative emotions the patient may have, and inviting them to complete a questionnaire.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西省 

市(区县)：

  

Country：

China 

Province：

Shanxi 

City：

 

单位(医院)：

第四军医大学唐都医院 

单位级别：

三甲 

Institution
hospital：

Tangdu Hospital, Fourth Military Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

垂体腺瘤心理困扰量表

指标类型：

主要指标

Outcome：

Pituitary Adenoma Psychological Distress Scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

社会支持量表

指标类型：

次要指标

Outcome：

Social Support Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

自我效能量表

指标类型：

次要指标

Outcome：

Self-efficacy Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

反刍思维量表

指标类型：

次要指标

Outcome：

Rumination scale

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 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）：

对照组和干预组分别纳入泌乳素瘤患者、库欣综合征患者、肢端肥大症患者及无症状型患者各14例。根据样本量计算结果，对符合纳入标准的各类型PitNETs患者1.编号：按照入院先后顺序进行编号1~28，2.随机数字：从随机数字表中的任一行任一列开始，依次读取28个两位数。3.编号对应随机数字：1~28号与选取的28个随机数字对应，4.确定组别：将全部随机数从小到大进行编序，规定序号 1~14为干预组。15~28为对照组。

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

The control group and intervention group each included 14 patients with prolactinomas, Cushing's syndrome, acromegaly, and asymptomatic cases. Based on sample size calculations, patients with various types of PitNETs who met the inclusion criteria were assigned the following: 1. Numbering: Patients were numbered sequentially from 1 to 28 based on the order of admission. 2.Random numbers: Starting from any row and column in the random number table, 28 two-digit numbers were sequentially read. 3.Assigning random numbers to patient numbers: The 28 patient numbers (1–28) were matched with the 28 randomly selected two-digit numbers. 4.Determining group assignments: All random numbers were sorted in ascending order, with numbers 1–14 assigned to the intervention group and numbers 15–28 to the control group.

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：

研究对象从入组到试验结束全程不知晓自身分组状态，研究者团队持有完整的随机分组表，可随时调阅受试者所属组别以便进行必要的临床干预

Blinding：

The study subjects were unaware of their group assignment throughout the entire study period, from enrollment to completion. The research team held the complete randomization table and could refer to it at any time to determine the group assignment of each subject in order to perform necessary clinical interventions.

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

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：

病例记录表

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

CRF

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：

  2025-08-20 09:05:18