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慢性特发性耳鸣患者临床特征分析及颊针疗法联合心理咨询治疗慢性特发性耳鸣的疗效研究
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注册号：

Registration number：

 ChiCTR2400083293 

最近更新日期：

Date of Last Refreshed on：

 2024-04-19 16:18:57 

注册时间：

Date of Registration：

 2024-04-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

慢性特发性耳鸣患者临床特征分析及颊针疗法联合心理咨询治疗慢性特发性耳鸣的疗效研究

Public title：

Analysis of the clinical characteristics of patients with chronic idiopathic tinnitus and the efficacy of buccal acupuncture combined with psychological counseling in the treatment of chronic idiopathic tinnitus

注册题目简写：

English Acronym：

研究课题的正式科学名称：

慢性特发性耳鸣患者临床特征分析及颊针疗法联合心理咨询治疗慢性特发性耳鸣的疗效研究

Scientific title：

Analysis of clinical characteristics of chronic idiopathic tinnitus patients and study on the effect of cheek acupuncture therapy combined with psychological counseling on chronic idiopathic tinnitus

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：

钟成 

研究负责人：

郭裕 

Applicant：

Cheng Zhong 

Study leader：

Yu Guo 

申请注册联系人电话：

Applicant telephone：

 +86 188 1396 7105

研究负责人电话：

Study leader's
telephone：

+86 181 1601 3560

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：

 12022167@shutcm.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 gyszyent@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：

上海市静安区芷江中路274号上海市中医医院

研究负责人通讯地址：

上海市静安区芷江中路274号上海市中医医院

Applicant address：

Shanghai Hospital of Traditional Chinese Medicine, No. 274 Zhijiang Middle Road, Jing'an District, Shanghai

Study leader's address：

Shanghai Hospital of Traditional Chinese Medicine, No. 274 Zhijiang Middle Road, Jing'an District, Shanghai

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：

上海中医药大学附属市中医医院

Applicant's institution：

Shanghai municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China

研究负责人所在单位：

上海中医药大学附属市中医医院

Affiliation of the Leader：

Shanghai municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China

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：

 2024SHL-KY-45-01

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：

上海市中医医院伦理委员会

Name of the ethic committee：

Ethics Committee of Shanghai Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-03-01 00:00:00

伦理委员会联系人：

凌丽

Contact Name of the ethic committee：

Li Ling

伦理委员会联系地址：

上海市静安区芷江中路274号上海市中医医院

Contact Address of the ethic committee：

Shanghai Hospital of Traditional Chinese Medicine, No. 274 Zhijiang Middle Road, Jing'an District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 5662 8310

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：

上海中医药大学附属市中医医院

Primary sponsor：

Shanghai municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China

研究实施负责（组长）单位地址：

上海市静安区芷江中路274号

Primary sponsor's address：

No. 274 Zhijiang Middle Road, Jing'an District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

静安

Country：

China

Province：

Shanghai

City：

Jing an

单位(医院)：

上海中医药大学附属市中医医院

具体地址：

上海市静安区芷江中路274号上海市中医医院

Institution
hospital：

Shanghai municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China

Address：

No. 274 Zhijiang Middle Road, Jing'an District, Shanghai

经费或物资来源：

自筹

Source(s) of funding：

self-funded

研究疾病：

耳鸣  

Target disease：

Tinnitus

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：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1.技术领域：探讨颊针疗法联合心理咨询治疗特发性耳鸣及其伴随症状的有效性。进一步为耳鸣治疗提供行之有效的治疗方法。 2.科学领域：丰富耳鸣针刺疗法的循证医学证据种类；并为颊针疗法联合心理咨询在特发性耳鸣的临床应用提供更充分的循证医学证据支持。  

Objectives of Study：

1. Technical field: to explore the effectiveness of buccal acupuncture therapy combined with psychological counseling in the treatment of idiopathic tinnitus and its accompanying symptoms. Further provide effective treatment for tinnitus treatment. 2. Scientific field: enrich the types of evidence-based medical evidence for tinnitus acupuncture therapy, and provide more adequate evidence-based medical evidence support for the clinical application of buccal acupuncture therapy combined with psychological counseling in idiopathic tinnitus.

药物成份或治疗方案详述：

本研究的第一部分为回顾性研究，探讨慢性特发性耳鸣的临床特征，为接下来的研究奠定基础。 本研究的第二部分为运用meta分析研究颊针联合心理疗法治疗特发性耳鸣疗效的循证医学依据，通过与本研究相关的meta分析，从循证医学角度给颊针联合心里疗法对特发性耳鸣的治疗效果提供依据。 本研究的主要部分为第三部分，前瞻性随机对照研究 具体如下： 本研究采用颊针疗法联合心理咨询疗法治疗慢性特发性耳鸣，开展较大样本量的随机对照的前瞻性临床研究观察颊针治疗耳鸣前后症状的变化，以TEQ、THI、HADS、PSQI量表和对耳鸣进行检测诊断和疗效判定。判断颊针疗法联合心理咨询疗法治疗耳鸣的近期和远期有效性，为治疗耳鸣提供更可靠的临床证据。 颊针疗法取穴为双侧颈穴、上颈穴、头穴、上焦穴、中焦穴、下焦穴、背穴、腰穴，颊针区反应点。 其中：颈穴、上颈穴、头穴是根据颊针全息理论，耳部疾病归属于头穴颈穴全息范畴所取；而上焦穴、中焦穴、下焦穴则是根据颊针“大三焦理论”及中医范畴中耳鸣的脏腑辨证原理及脏腑所从属的三焦分布定位，具有燮理全身气血之功；此外，人体的五脏同五官是相通的，因此五官的疾病可涉及到全身各个脏腑，呈现“亚健康状态”进而在面颊部产生其他反应点，这些反应点往往蕴含着疾病的症结——即中医理论中“独处藏奸”，如患者在颊针治疗中探查到其他颊针反应点，反应点处亦应该取穴，此类穴位可涉及到背穴（背为肺之府，肺经之结穴在耳中，名曰笼葱，专主乎听）、腰穴、下腰穴、骨盆带（腰为肾之府，肾开窍于耳）等。 针具的选择：选择0.18mm×30mm的针具（乐灸牌刚柄针灸针；马鞍山邦德医疗器械有限公司）针刺过程讲求“无痛”原则，进针的同时询问患者是否感觉到疼痛，若针下滞涩或患者出现针刺样疼痛感，则应调整针尖方向，继续进针，针刺过程中以滑利为要。 心理咨询疗法：对每例患者进行每周2次的耳鸣心理咨询，持续4周。根据患者具体病情及检查结果对患者的耳鸣作出相应诊断，并如实告知患者耳鸣的可能原因及严重程度，详尽解释耳鸣的发生发展机制，让患者了解自身耳鸣治愈的可能性及预后等，增强患者对治疗耳鸣的信心，帮助患者调节耳鸣所带来的焦虑、抑郁、睡眠障碍等心理情绪不良反应。提供结构化的患者教育，咨询和日常耳鸣生活的提示。根据2019年发布的欧洲指南制定[99]，治疗目的在于帮助患者认识到哪些信念或行为是无益的。 ①根据患者具体病情及检查结果对患者耳鸣作出相应诊断，耐心向患者传授耳鸣的相关知识、解释耳鸣的病理生理机制，让患者了解自身耳鸣的发病原因、治愈的可能性及预后等情况；对于排除占位性病变的患者要明确告知目前没有发现肿瘤的迹象； ②让患者知道耳鸣有可能无法根除，但可以学会与之共存，可以把耳鸣比作冰箱噪声、亲属鼾声，达到尽快适应耳鸣； ③转移注意力：告知患者一旦感到耳鸣，就立即把注意力转移到其他事情上，做自己感兴趣的事，如读报、看电视、听收音机等，忽略耳鸣的存在； ④松弛训练：教会患者用意念控制神经和肌肉的紧张性，从头面部肌肉开始放松，逐渐将上下肢、胸部乃至全身的肌肉放松，让患者身心松弛，缓解焦虑、抑郁等情绪；一天两次，每次10-20min，通常在晨起与睡前进行； ⑤自助疗法：通过患者自身调整或患者之间相互帮助以缓解耳鸣症状的方法。对于初患耳鸣者，不管其心理承受能力如何，都应劝慰病人在积极治疗的同时，必须减轻心理负担，面对现实、正视现实，对耳鸣的存在要容忍，保持愉快的心情。  

Description for medicine or protocol of treatment in detail：

The first part of this study is a retrospective study to explore the clinical features of chronic idiopathic tinnitus and lay the foundation for subsequent studies. The second part of this study is to use a meta-analysis to study the evidence-based medical basis for the efficacy of buccal acupuncture combined with psychotherapy in the treatment of idiopathic tinnitus, and to provide a basis for the treatment effect of buccal acupuncture combined with psychotherapy for idiopathic tinnitus from the perspective of evidence-based medicine through the meta-analysis related to this study. The main part of this study is the third part, a prospective randomized controlled study The details are as follows: In this study, buccal acupuncture therapy combined with psychological counseling therapy was used to treat chronic idiopathic tinnitus, and a large sample size of randomized controlled prospective clinical studies was carried out to observe the changes in symptoms before and after buccal acupuncture treatment of tinnitus, and the TEQ, THI, HADS, PSQI scales and tinnitus were used to detect and diagnose and determine the efficacy. To determine the short-term and long-term effectiveness of buccal acupuncture combined with psychological counseling therapy in the treatment of tinnitus, so as to provide more reliable clinical evidence for the treatment of tinnitus. The acupoints taken by buccal acupuncture therapy are bilateral neck acupoints, upper neck acupoints, head acupoints, upper focal acupoints, middle acupoints, lower coke acupoints, back acupoints, waist acupoints, and buccal acupuncture reaction points. Among them: the neck acupoint, the upper neck acupoint and the head acupoint are based on the holographic theory of buccal acupuncture, and the ear diseases belong to the holographic category of the head acupoint and cervical acupoint, while the upper Jiao acupoint, the middle Jiao acupoint and the lower Jiao acupoint are based on the "big three-focal theory" of the buccal acupuncture and the viscera syndrome differentiation principle of tinnitus in the field of traditional Chinese medicine and the trifocal distribution of the viscera to which the viscera is subordinate, which has the function of regulating the qi and blood of the whole body And then produce other reaction points in the cheeks, these reaction points often contain the crux of the disease - that is, the theory of traditional Chinese medicine "alone and hiding adultery", such as the patient in the buccal acupuncture treatment to explore other buccal acupuncture reaction points, the reaction points should also take acupoints, such acupuncture points can involve the back acupoints (the back is the house of the lungs, the knot points of the lung meridian are in the ears, the name is called the cage onion, the main thing is to listen), waist acupoints, lower waist acupoints, pelvic belt (the waist is the house of the kidney, the kidney is open to the ear) and so on. Selection of acupuncture: choose 0.18mm×30mm acupuncture (Lemoxibustion brand rigid handle acupuncture needle; Ma'anshan Bond Medical Equipment Co., Ltd.) The acupuncture process emphasizes the principle of "painless", and asks the patient whether he feels pain while inserting the needle. Psychological counseling therapy: Tinnitus psychological counseling is given to each patient twice a week for 4 weeks. According to the specific condition of the patient and the results of the examination, the corresponding diagnosis of the patient's tinnitus is made, and the possible causes and severity of the tinnitus are truthfully informed, the occurrence and development mechanism of tinnitus is explained in detail, so that the patient can understand the possibility and prognosis of his own tinnitus cure, enhance the patient's confidence in the treatment of tinnitus, and help the patient regulate the anxiety, depression, sleep disorders and other psychological and emotional adverse reactions caused by tinnitus. Provide structured patient education [107], counseling, and tips for daily tinnitus living. According to European guidelines published in 2019, the goal of treatment is to help patients recognize which beliefs or behaviors are unhelpful. (1) According to the specific condition of the patient and the results of the examination, the corresponding diagnosis of the patient's tinnitus, patiently teach the relevant knowledge of tinnitus, explain the pathophysiological mechanism of tinnitus, and let the patient understand the cause of his own tinnitus, the possibility of cure and the prognosis; (2) Let patients know that tinnitus may not be eradicated, but they can learn to coexist with it, and they can compare tinnitus to refrigerator noise and snoring of relatives, so as to adapt to tinnitus as soon as possible; (3) Divert attention: Inform patients that once they feel tinnitus, they should immediately shift their attention to other things, do what they are interested in, such as reading newspapers, watching TV, listening to the radio, etc., and ignore the existence of tinnitus; (4) Relaxation training: teach patients to control the tension of nerves and muscles with their minds, start to relax from the head and face muscles, and gradually relax the muscles of the upper and lower limbs, chest and even the whole body, so that the patient's body and mind can relax, relieve anxiety, depression and other emotions; twice a day, 10-20min each time, usually in the morning and before going to bed; (5) Self-help therapy: a method of relieving tinnitus symptoms through patients' self-adjustment or mutual help between patients. For patients with tinnitus for the first time, regardless of their psychological tolerance, they should be comforted to reduce their psychological burden while actively treating, face reality, face reality, tolerate the existence of tinnitus, and maintain a happy mood.  

纳入标准：

Inclusion criteria

排除标准：

第一部分 慢性特发性耳鸣患者临床特征分析 排除标准 ①排除中耳炎，耳硬化症，耳垢阻塞外耳道等局部因素诱发耳鸣的原因； ②排除外伤、手术、自身免疫性疾病、听神经瘤等导致器质性病变引起耳鸣的原因； ③排除甲状腺、高血压、贫血等内科疾病诱发肌肉痉挛、血管紧张，从而导致客观性耳鸣的原因； ④排除符合精神类及心理类疾病诊断，严重精神心理障碍诱发耳鸣的原因，且无法接受治疗及随访者； ⑤排除耳毒性药物使用（如化疗等）诱发耳鸣的原因； ⑥妊娠。 第三部分 颊针疗法联合心理咨询治疗慢性特发性耳鸣的前瞻性随机对照临床研究 排除标准 ①排除中耳炎，耳硬化症，耳垢阻塞外耳道等局部因素诱发耳鸣的原因； ②排除外伤、手术、自身免疫性疾病、听神经瘤等导致器质性病变引起耳鸣的原因； ③排除甲状腺、高血压、贫血等内科疾病诱发肌肉痉挛、血管紧张，从而导致客观性耳鸣的原因； ④排除符合精神类及心理类疾病诊断，严重精神心理障碍诱发耳鸣的原因，且无法接受治疗及随访者； ⑤排除耳毒性药物使用（如化疗等）诱发耳鸣的原因； ⑥妊娠； ⑦近2周内接受过耳鸣治疗的患者。

Exclusion criteria：

Part I: Analysis of the clinical characteristics of patients with chronic idiopathic tinnitus Exclusion Criteria: (1) Exclude the causes of tinnitus induced by local factors such as otitis media, otosclerosis, and earwax obstruction of the external auditory canal; (2) Exclude the causes of tinnitus caused by organic lesions such as trauma, surgery, autoimmune diseases, acoustic neuroma, etc.; (3) Exclude the causes of objective tinnitus caused by thyroid, hypertension, anemia and other internal diseases that induce muscle spasm and vascular tension; (4) Those who are eligible for the diagnosis of psychiatric and psychological diseases, have the cause of tinnitus caused by severe mental and psychological disorders, and are unable to receive treatment and follow-up; (5) to rule out the cause of tinnitus induced by the use of ototoxic drugs (such as chemotherapy, etc.); (6) Pregnancy. Part III A prospective randomized controlled clinical study of buccal acupuncture combined with psychological counseling in the treatment of chronic idiopathic tinnitus Exclusion Criteria: (1) Exclude the causes of tinnitus induced by local factors such as otitis media, otosclerosis, and earwax obstruction of the external auditory canal; (2) Exclude the causes of tinnitus caused by organic lesions such as trauma, surgery, autoimmune diseases, acoustic neuroma, etc.; (3) Exclude the causes of objective tinnitus caused by thyroid, hypertension, anemia and other internal diseases that induce muscle spasm and vascular tension; (4) Those who are eligible for the diagnosis of psychiatric and psychological diseases, have the cause of tinnitus caused by severe mental and psychological disorders, and are unable to receive treatment and follow-up; (5) To rule out the cause of tinnitus induced by the use of ototoxic drugs (such as chemotherapy, etc.); (6) Pregnancy; (7) Patients who have received tinnitus treatment in the past 2 weeks.

研究实施时间：

Study execute time：

从 From 2024-04-22 00:00:00至 To 2025-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-04-22 00:00:00 至 To 2025-06-30 00:00:00

干预措施：

Interventions：

组别：

第三部分 前瞻性研究 实验组

样本量：

 40

Group：

Experimental group

Sample size：

干预措施：

实验组：颊针疗法＋心理咨询治疗。 心理咨询疗法：对每例患者进行每周2次的耳鸣心理咨询，持续4周。根据患者具体病情及检查结果对患者的耳鸣作出相应诊断，并如实告知患者耳鸣的可能原因及严重程度，详尽解释耳鸣的发生发展机制，让患者了解自身耳鸣治愈的可能性及预后等，增强患者对治疗耳鸣的信心，帮助患者调节耳鸣所带来的焦虑、抑郁、睡眠障碍等心理情绪不良反应。提供结构化的患者教育，咨询和日常耳鸣生活的提示。根据2019年发布的欧洲指南制定，治疗目的在于帮助患者认识到哪些信念或行为是无益的。 ①根据患者具体病情及检查结果对患者耳鸣作出相应诊断，耐心向患者传授耳鸣的相关知识、解释耳鸣的病理生理机制，让患者了解自身耳鸣的发病原因、治愈的可能性及预后等情况；对于排除占位性病变的患者要明确告知目前没有发现肿瘤的迹象； ②让患者知道耳鸣有可能无法根除，但可以学会与之共存，可以把耳鸣比作冰箱噪声、亲属鼾声，达到尽快适应耳鸣； ③转移注意力：告知患者一旦感到耳鸣，就立即把注意力转移到其他事情上，做自己感兴趣的事，如读报、看电视、听收音机等，忽略耳鸣的存在； ④松弛训练：教会患者用意念控制神经和肌肉的紧张性，从头面部肌肉开始放松，逐渐将上下肢、胸部乃至全身的肌肉放松，让患者身心松弛，缓解焦虑、抑郁等情绪；一天两次，每次10-20min，通常在晨起与睡前进行； ⑤自助疗法： 通过患者自身调整或患者之间相互帮助以缓解耳鸣症状的方法。对于初患耳鸣者，不管其心理承受能力如何，都应劝慰病人在积极治疗的同时，必须减轻心理负担，面对现实、正视现实，对耳鸣的存在要容忍，保持愉快的心情。 颊针取穴：双侧颈穴、上颈穴、头穴、上焦穴、中焦穴、下焦穴、背穴、腰穴，颊针区反应点。留针20分钟。2次/周，4周为一疗程。

干预措施代码：

Intervention：

Experimental group: buccal acupuncture therapy + psychological counseling treatment. Psychological counseling therapy: Tinnitus psychological counseling is given to each patient twice a week for 4 weeks. According to the specific condition of the patient and the results of the examination, the corresponding diagnosis of the patient's tinnitus is made, and the possible causes and severity of the tinnitus are truthfully informed, the occurrence and development mechanism of tinnitus is explained in detail, so that the patient can understand the possibility and prognosis of his own tinnitus cure, enhance the patient's confidence in the treatment of tinnitus, and help the patient regulate the anxiety, depression, sleep disorders and other psychological and emotional adverse reactions caused by tinnitus. Provide structured patient education , counseling, and tips for daily tinnitus living. According to European guidelines published in 2019 , the goal of treatment is to help patients recognize which beliefs or behaviors are unhelpful. (1) According to the specific condition of the patient and the results of the examination, the corresponding diagnosis of the patient's tinnitus, patiently teach the relevant knowledge of tinnitus, explain the pathophysiological mechanism of tinnitus, and let the patient understand the cause of his own tinnitus, the possibility of cure and the prognosis; (2) Let patients know that tinnitus may not be eradicated, but they can learn to coexist with it, and they can compare tinnitus to refrigerator noise and snoring of relatives, so as to adapt to tinnitus as soon as possible; (3) Divert attention: Inform patients that once they feel tinnitus, they should immediately shift their attention to other things, do what they are interested in, such as reading newspapers, watching TV, listening to the radio, etc., and ignore the existence of tinnitus; (4) Relaxation training: teach patients to control the tension of nerves and muscles with their minds, start to relax from the head and face muscles, and gradually relax the muscles of the upper and lower limbs, chest and even the whole body, so that the patient's body and mind can relax, relieve anxiety, depression and other emotions; twice a day, 10-20min each time, usually in the morning and before going to bed; (5) Self-help therapy: A method of relieving tinnitus symptoms through patients' own adjustment or mutual help between patients. For patients with tinnitus for the first time, regardless of their psychological tolerance, they should be comforted to reduce their psychological burden while actively treating, face reality, face reality, tolerate the existence of tinnitus, and maintain a happy mood. Buccal acupuncture points: bilateral neck acupoints, upper neck acupoints, head acupoints, upper coke acupoints, middle acupoints, lower coke acupoints, back acupoints, waist acupoints, buccal acupuncture area reaction points. Leave the needle on for 20 minutes. 2 times/week, 4 weeks as a course of treatment.

Intervention code：

组别：

第三部分 前瞻性研究 对照组

样本量：

 40

Group：

Control group

Sample size：

干预措施：

仅进行心理咨询治疗。 心理咨询疗法：对每例患者进行每周2次的耳鸣心理咨询，持续4周。根据患者具体病情及检查结果对患者的耳鸣作出相应诊断，并如实告知患者耳鸣的可能原因及严重程度，详尽解释耳鸣的发生发展机制，让患者了解自身耳鸣治愈的可能性及预后等，增强患者对治疗耳鸣的信心，帮助患者调节耳鸣所带来的焦虑、抑郁、睡眠障碍等心理情绪不良反应。提供结构化的患者教育，咨询和日常耳鸣生活的提示。根据2019年发布的欧洲指南制定，治疗目的在于帮助患者认识到哪些信念或行为是无益的。 ①根据患者具体病情及检查结果对患者耳鸣作出相应诊断，耐心向患者传授耳鸣的相关知识、解释耳鸣的病理生理机制，让患者了解自身耳鸣的发病原因、治愈的可能性及预后等情况；对于排除占位性病变的患者要明确告知目前没有发现肿瘤的迹象； ②让患者知道耳鸣有可能无法根除，但可以学会与之共存，可以把耳鸣比作冰箱噪声、亲属鼾声，达到尽快适应耳鸣； ③转移注意力：告知患者一旦感到耳鸣，就立即把注意力转移到其他事情上，做自己感兴趣的事，如读报、看电视、听收音机等，忽略耳鸣的存在； ④松弛训练：教会患者用意念控制神经和肌肉的紧张性，从头面部肌肉开始放松，逐渐将上下肢、胸部乃至全身的肌肉放松，让患者身心松弛，缓解焦虑、抑郁等情绪；一天两次，每次10-20min，通常在晨起与睡前进行； ⑤自助疗法： 通过患者自身调整或患者之间相互帮助以缓解耳鸣症状的方法。对于初患耳鸣者，不管其心理承受能力如何，都应劝慰病人在积极治疗的同时，必须减轻心理负担，面对现实、正视现实，对耳鸣的存在要容忍，保持愉快的心情。

干预措施代码：

Intervention：

Psychological counseling treatment only. Psychological counseling therapy: Tinnitus psychological counseling is given to each patient twice a week for 4 weeks. According to the specific condition of the patient and the results of the examination, the corresponding diagnosis of the patient's tinnitus is made, and the possible causes and severity of the tinnitus are truthfully informed, the occurrence and development mechanism of tinnitus is explained in detail, so that the patient can understand the possibility and prognosis of his own tinnitus cure, enhance the patient's confidence in the treatment of tinnitus, and help the patient regulate the anxiety, depression, sleep disorders and other psychological and emotional adverse reactions caused by tinnitus. Provide structured patient education, counseling, and tips for daily tinnitus living. According to European guidelines published in 2019, the goal of treatment is to help patients recognize which beliefs or behaviors are unhelpful. (1) According to the specific condition of the patient and the results of the examination, the corresponding diagnosis of the patient's tinnitus, patiently teach the relevant knowledge of tinnitus, explain the pathophysiological mechanism of tinnitus, and let the patient understand the cause of his own tinnitus, the possibility of cure and the prognosis; (2) Let patients know that tinnitus may not be eradicated, but they can learn to coexist with it, and they can compare tinnitus to refrigerator noise and snoring of relatives, so as to adapt to tinnitus as soon as possible; (3) Divert attention: Inform patients that once they feel tinnitus, they should immediately shift their attention to other things, do what they are interested in, such as reading newspapers, watching TV, listening to the radio, etc., and ignore the existence of tinnitus; (4) Relaxation training: teach patients to control the tension of nerves and muscles with their minds, start to relax from the head and face muscles, and gradually relax the muscles of the upper and lower limbs, chest and even the whole body, so that the patient's body and mind can relax, relieve anxiety, depression and other emotions; twice a day, 10-20min each time, usually in the morning and before going to bed; (5) Self-help therapy: A method of relieving tinnitus symptoms through patients' own adjustment or mutual help between patients. For patients with tinnitus for the first time, regardless of their psychological tolerance, they should be comforted to reduce their psychological burden while actively treating, face reality, face reality, tolerate the existence of tinnitus, and maintain a happy mood.

Intervention code：

组别：

第一部分，回顾性研究，慢性特发性耳鸣临床特征

样本量：

 200

Group：

Part I, a retrospective study, clinical features of chronic idiopathic tinnitus

Sample size：

干预措施：

（一）慢性特发性耳鸣患者出现失代偿的危险因素分析 1.研究内容 本研究探讨慢性特发性耳鸣患者耳鸣特征及出现失代偿的危险因素，为前瞻性临床研究奠定基础。参考大量文献研究结论[101-103]，根据耳鸣严重程度的影响因素的可能数目估计样本量，拟纳入慢性特发性耳鸣患者200例。 2.研究设计 2.1病例来源 病例来源于上海中医药大学附属上海市中医医院耳鼻喉科门诊患者，凡符合慢性特发性耳鸣诊断的患者均纳入。经患者知情同意，遵照纳排标准纳入研究。 2.2病例筛选 2.2.1诊断标准 诊断标准：参考《欧洲多学科耳鸣指南》[99]及《耳鸣临床应用指南》中有关耳鸣的诊断标准拟定。①慢性特发性耳鸣：收集全面的听力学病史获得以下信息，即患者在无外界声源刺激的条件下，自觉单侧或双侧耳中鸣响，伴有或不伴有听力下降，听觉过敏，睡眠障碍，心烦、焦虑等，耳鸣持续时间≥6个月；②听力学检查（纯音测听、声导抗、耳声发射、耳鸣频率匹配等）;若为单侧耳鸣和/或非对称性听力损失的病例，则应做影像学检查排除耳内器质性病变及占位病变；并做听力学检查，排除突发性聋。[99,109] 2.2.2纳入标准 ①符合慢性特发性耳鸣诊断标准，耳鸣持续时间≥6个月； ②年龄18-80岁，性别不限； ③有良好沟通能力，能够顺利完成量表填写； ④受试者知情，自愿签署知情同意书。 2.2.3排除标准 ①排除中耳炎，耳硬化症，耳垢阻塞外耳道等局部因素诱发耳鸣的原因； ②排除外伤、手术、自身免疫性疾病、听神经瘤等导致器质性病变引起耳鸣的原因； ③排除甲状腺、高血压、贫血等内科疾病诱发肌肉痉挛、血管紧张，从而导致客观性耳鸣的原因； ④排除符合精神类及心理类疾病诊断，严重精神心理障碍诱发耳鸣的原因，且无法接受治疗及随访者； ⑤排除耳毒性药物使用（如化疗等）诱发耳鸣的原因； ⑥妊娠。 2.3研究内容 填写耳鸣患者基本情况量表，THI、TEQ、HADS、PSQI、VAS量表，了解患者一般状况，完善耳内镜、纯音听阈、声导抗、耳声发射、耳鸣频率匹配检查了解患者一般听力状况。THI≥58分代表失代偿性耳鸣[108]。 2.4统计分析 运用SPSS软件进行统计学分析，进行二元logistics回归分析，分析耳鸣发生失代偿的危险因素。 （二）慢性特发性耳鸣患者严重程度的影响因素分析 1.研究内容 本研究在先前病例收集基础上，探讨慢性特发性耳鸣患者耳鸣严重程度的影响因素，分析不同影响因素与耳鸣严重程度之间的相关性。 2.研究设计 2.1病例来源 病例来源于上海中医药大学附属上海市中医医院耳鼻喉科门诊患者，凡符合慢性特发性耳鸣诊断的患者均纳入。经患者知情同意，遵照纳排标准纳入研究。 2.2病例筛选 2.2.1诊断标准 诊断标准：参考《欧洲多学科耳鸣指南》[99]及《耳鸣临床应用指南》中有关耳鸣的诊断标准拟定。①慢性特发性耳鸣：收集全面的听力学病史获得以下信息，即患者在无外界声源刺激的条件下，自觉单侧或双侧耳中鸣响，伴有或不伴有听力下降，听觉过敏，睡眠障碍，心烦、焦虑等，耳鸣持续时间≥6个月；②听力学检查（纯音测听、声导抗、耳声发射、耳鸣频率匹配等）;若为单侧耳鸣和/或非对称性听力损失的病例，则应做影像学检查排除耳内器质性病变及占位病变；并做听力学检查，排除突发性聋。[99,109] 2.2.2纳入标准 ①符合慢性特发性耳鸣诊断标准，耳鸣持续时间≥6个月； ②年龄18-80岁，性别不限； ③有良好沟通能力，能够顺利完成量表填写； ④受试者知情，自愿签署知情同意书。 2.2.3排除标准 ①排除中耳炎，耳硬化症，耳垢阻塞外耳道等局部因素诱发耳鸣的原因； ②排除外伤、手术、自身免疫性疾病、听神经瘤等导致器质性病变引起耳鸣的原因； ③排除甲状腺、高血压、贫血等内科疾病诱发肌肉痉挛、血管紧张，从而导致客观性耳鸣的原因； ④排除符合精神类及心理类疾病诊断，严重精神心理障碍诱发耳鸣的原因，且无法接受治疗及随访者； ⑤排除耳毒性药物使用（如化疗等）诱发耳鸣的原因； ⑥妊娠。 2.3研究内容 填写耳鸣患者基本情况量表，THI、TEQ、HADS、PSQI、VAS量表，了解患者一般状况，完善耳内镜、纯音听阈、声导抗、耳声发射、耳鸣频率匹配检查了解患者一般听力状况。通过THI评分为评估耳鸣严重程度的量化指标进行统计分析。 2.4统计分析 运用SPSS软件进行统计学分析，进行二元logistics回归分析及高级统计学方法，分析不同影响因素与耳鸣严重程度之间的相关性。 由于回顾性研究和前瞻性研究可以同时进行，因此，回顾性研究样本量200可与前瞻性研究80样本量合并，最大样本量为200例

干预措施代码：

Intervention：

(1) Analysis of risk factors for decompensation in patients with chronic idiopathic tinnitus 1. Research content This study investigated the characteristics of tinnitus and the risk factors for decompensation in patients with chronic idiopathic tinnitus, and laid the foundation for prospective clinical research. Referring to the conclusions of a large number of literature studies [101-103], the sample size was estimated according to the possible number of factors influencing the severity of tinnitus, and 200 patients with chronic idiopathic tinnitus were planned to be included. 2. Study design 2.1 Source of cases The case originated from an outpatient patient in the Department of Otolaryngology, Shanghai Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, and all patients who met the diagnosis of chronic idiopathic tinnitus were included. With the informed consent of the patients, the study was included in accordance with the inclusion criteria. 2.2 Case screening 2.2.1 Diagnostic criteria Diagnostic criteria: Diagnostic criteria for tinnitus are based on the European Multidisciplinary Guidelines for Tinnitus [99] and the Guidelines for the Clinical Use of Tinnitus. (1) Chronic idiopathic tinnitus: collect a comprehensive audiological history to obtain the following information, that is, the patient feels unilateral or bilateral ringing in the ears without external sound source stimulation, with or without hearing loss, hyperacusis, sleep disorders, upset, anxiety, etc., and the duration of tinnitus is ≥ 6 months; (2) Audiological examination (pure tone audiometry, acoustic impedance, otoacoustic emission, tinnitus frequency matching, etc.); In cases of unilateral tinnitus and/or asymmetric hearing loss, imaging should be done to rule out intraauricular organic and mass lesions; An audiology test is done to rule out sudden deafness. [99,109] 2.2.2 Inclusion Criteria (1) Meet the diagnostic criteria for chronic idiopathic tinnitus, and the duration of tinnitus ≥ 6 months; (2) Age 18-80 years old, gender is not limited; (3) Have good communication skills and be able to successfully complete the scale filling; (4) The subject is informed and voluntarily signs the informed consent form. 2.2.3 Exclusion Criteria (1) Exclude the causes of tinnitus induced by local factors such as otitis media, otosclerosis, and earwax obstruction of the external auditory canal; (2) Exclude the causes of tinnitus caused by organic lesions such as trauma, surgery, autoimmune diseases, acoustic neuroma, etc.; (3) Exclude the causes of objective tinnitus caused by thyroid, hypertension, anemia and other internal diseases that induce muscle spasm and vascular tension; (4) Those who are eligible for the diagnosis of psychiatric and psychological diseases, have the cause of tinnitus caused by severe mental and psychological disorders, and are unable to receive treatment and follow-up; (5) to rule out the cause of tinnitus induced by the use of ototoxic drugs (such as chemotherapy, etc.); (6) Pregnancy. 2.3 Research content Fill in the basic situation scale of patients with tinnitus, THI, TEQ, HADS, PSQI, VAS scales, understand the general condition of patients, and improve the examination of otoendoscopy, pure tone hearing threshold, acoustic impedance, otoacoustic emission and tinnitus frequency matching to understand the general hearing status of patients. A THI score of ≥58 represents decompensated tinnitus [108]. 2.4 Statistical Analysis SPSS software was used for statistical analysis, and binary logistics regression analysis was performed to analyze the risk factors of tinnitus decompensation. (2) Analysis of influencing factors of the severity of patients with chronic idiopathic tinnitus 1. Research content Based on the previous case collection, this study explored the influencing factors of tinnitus severity in patients with chronic idiopathic tinnitus, and analyzed the correlation between different influencing factors and tinnitus severity. 2. Study design 2.1 Source of cases The case originated from an outpatient patient in the Department of Otolaryngology, Shanghai Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, and all patients who met the diagnosis of chronic idiopathic tinnitus were included. With the informed consent of the patients, the study was included in accordance with the inclusion criteria. 2.2 Case screening 2.2.1 Diagnostic criteria Diagnostic criteria: Diagnostic criteria for tinnitus are based on the European Multidisciplinary Guidelines for Tinnitus [99] and the Guidelines for the Clinical Use of Tinnitus. (1) Chronic idiopathic tinnitus: collect a comprehensive audiological history to obtain the following information, that is, the patient feels unilateral or bilateral ringing in the ears without external sound source stimulation, with or without hearing loss, hyperacusis, sleep disorders, upset, anxiety, etc., and the duration of tinnitus is ≥ 6 months; (2) Audiological examination (pure tone audiometry, acoustic impedance, otoacoustic emission, tinnitus frequency matching, etc.); In cases of unilateral tinnitus and/or asymmetric hearing loss, imaging should be done to rule out intraauricular organic and mass lesions; An audiology test is done to rule out sudden deafness. [99,109] 2.2.2 Inclusion Criteria (1) Meet the diagnostic criteria for chronic idiopathic tinnitus, and the duration of tinnitus ≥ 6 months; (2) Age 18-80 years old, gender is not limited; (3) Have good communication skills and be able to successfully complete the scale filling; (4) The subject is informed and voluntarily signs the informed consent form. 2.2.3 Exclusion Criteria (1) Exclude the causes of tinnitus induced by local factors such as otitis media, otosclerosis, and earwax obstruction of the external auditory canal; (2) Exclude the causes of tinnitus caused by organic lesions such as trauma, surgery, autoimmune diseases, acoustic neuroma, etc.; (3) Exclude the causes of objective tinnitus caused by thyroid, hypertension, anemia and other internal diseases that induce muscle spasm and vascular tension; (4) Those who are eligible for the diagnosis of psychiatric and psychological diseases, have the cause of tinnitus caused by severe mental and psychological disorders, and are unable to receive treatment and follow-up; (5) to rule out the cause of tinnitus induced by the use of ototoxic drugs (such as chemotherapy, etc.); (6) Pregnancy. 2.3 Research content Fill in the basic situation scale of patients with tinnitus, THI, TEQ, HADS, PSQI, VAS scales, understand the general condition of patients, and improve the examination of otoendoscopy, pure tone hearing threshold, acoustic impedance, otoacoustic emission and tinnitus frequency matching to understand the general hearing status of patients. The THI score was used as a quantitative indicator to assess the severity of tinnitus. 2.4 Statistical Analysis SPSS software was used for statistical analysis, binary logistics regression analysis and advanced statistical methods were used to analyze the correlation between different influencing factors and tinnitus severity. Since retrospective and prospective studies can be conducted simultaneously, the retrospective study sample size of 200 can be combined with the prospective study sample size of 80 cases, with a maximum sample size of 200 cases

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海  

市(区县)：

 静安 

Country：

China

Province：

Shanghai

City：

Jingan

单位(医院)：

 上海中医药大学附属市中医医院 

单位级别：

 三甲 

Institution
hospital：

Shanghai municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

耳鸣致残量表（THI）--第一部分、第三部分

指标类型：

主要指标

Outcome：

Tinnitus Disability Scale (THI)

Type：

Primary indicator

测量时间点：

初诊首日、治疗结束后、治疗结束后3个月

测量方法：

Measure time point of outcome：

On the first day of initial consultation, after the end of treatment, and 3 months after the end of treatment

Measure method：

指标中文名：

耳鸣严重程度量表（TEQ）--第一部分、第三部分

指标类型：

主要指标

Outcome：

Tinnitus Severity Scale (TEQ)

Type：

Primary indicator

测量时间点：

初诊首日、治疗结束后、治疗结束后3个月（第三部分），第一部分为回顾性研究，仅填写1次问卷调查

测量方法：

Measure time point of outcome：

On the first day of initial consultation, after the end of treatment, and 3 months after the end of treatment (Part III), the first part was a retrospective study, and only one questionnaire was filled

Measure method：

指标中文名：

焦虑抑郁量表（HADS）---第一部分、第三部分

指标类型：

次要指标

Outcome：

Anxiety and Depression Scale (HADS)

Type：

Secondary indicator

测量时间点：

初诊首日、治疗结束后、治疗结束后3个月（第三部分），第一部分为回顾性研究，仅填写1次问卷调查

测量方法：

Measure time point of outcome：

On the first day of initial consultation, after the end of treatment, and 3 months after the end of treatment (Part III), the first part was a retrospective study, and only one questionnaire was filled

Measure method：

指标中文名：

匹兹堡睡眠质量指数（PSQI）--第一部分、第三部分

指标类型：

次要指标

Outcome：

Pittsburgh Sleep Quality Index (PSQI)

Type：

Secondary indicator

测量时间点：

初诊首日、治疗结束后、治疗结束后3个月（第三部分），第一部分为回顾性研究，仅填写1次问卷调查

测量方法：

Measure time point of outcome：

On the first day of initial consultation, after the end of treatment, and 3 months after the end of treatment (Part III), the first part was a retrospective study, and only one questionnaire was filled

Measure method：

指标中文名：

耳鸣VAS评分

指标类型：

次要指标

Outcome：

Tinnitus VAS score

Type：

Secondary indicator

测量时间点：

初诊首日、治疗结束后、治疗结束后3个月（第三部分），第一部分为回顾性研究，仅填写1次问卷调查

测量方法：

Measure time point of outcome：

On the first day of initial consultation, after the end of treatment, and 3 months after the end of treatment (Part III), the first part was a retrospective study, and only one questionnaire was filled

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

Tissue：

None

人体标本去向

 其它  

说明

无

Fate of sample：

0thers  

Note：

None

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 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）：

前瞻性研究按照简单随机、对照、平行原则。借助EXCEL软件“=rand()”建立随机数字，随机分为2组。在课题负责人统一组织下，严格按照制定的研究设计方案进行临床研究。本研究因实验自身属性限制，无法设盲。

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

Simple random, controlled, parallel principle. With the help of the EXCEL software "=rand()", random numbers are created and randomly divided into 2 groups. Under the unified organization of the person in charge of the project, the clinical research is carried out in strict accordance with the formulated research design plan. Due to the limitations of the experiment's own attributes, this study could not be blinded.

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：

本研究因实验自身属性限制，无法设盲

Blinding：

Due to the limitations of the experiment's own attributes, this study could not be blinded

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

是Yes

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）：

病例记录表

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

Case Record Form, CRF

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：

Case Record Form, 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：

  2024-04-19 16:18:52
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