研究疾病:
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失眠
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研究疾病代码:
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Target disease:
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insomnia
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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病例对照研究
Case-Control study
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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探讨腹部推拿中的振腹环揉法对原发性失眠患者脑网络功能链接的影响,从脑功能影像学角度分析腹部推拿治疗原发性失眠的作用机制。
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Objectives of Study:
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To explore the effect of vibrating abdomen and ring rubbing method in abdominal massage on the brain of patients with primary insomnia.The influence of network functional links, and the mechanism of abdominal massage in the treatment of primary insomnia from the perspective of brain function imaging.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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1. 心脾两虚型慢性失眠纳入标准;
2. 符合原发性失眠诊断标准及心脾两虚诊断标准,睡眠和觉醒困难不能被其他类型的睡眠障碍更好的解释,同时符合以下7项条件:
①符合失眠障碍诊断标准,符合心脾两虚型原发性失眠标准;
②50周岁≤年龄≤55周岁者;
③未参加其他临床研究者;
④签署知情同意书,自愿参加本项研究者;
⑤匹兹堡睡眠指数(PSQI)指数>7分,阿森斯(AIS)量表积分>6分。抑郁量表(SDS)和焦虑量表(SAS)标准分≤60分者;
⑥观察期内无工作压力和生活压力;
⑦无心脑血管疾病和其他器质性疾病;血尿常规、心电图、脑电图、肝肾功能、血糖血脂等理化检查指标正常。
3. 且上述症状持续1年以上,频率≥3次/周的患者,方可纳入本项研究。
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Inclusion criteria
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1. Insomnia volunteers were included in the criteria
2. In line with the diagnostic criteria for primary insomnia and deficiency of the heart and spleen, difficulty in sleeping and awakening cannot be better explained by other types of sleep disorders, and the following seven conditions are met:
A. It meets the diagnostic criteria of insomnia disorder and primary insomnia with deficiency of heart and spleen;
B. Aged 50-55 years;
C. Did not participate in other clinical researchers;
D. Signed the informed consent form and volunteered to participate in the study;
E. PSQI > 7 points, AIS > 6 points, SDS and SAS <= 60;
F. No work pressure or life pressure during the observation period;
G. Centerless cerebrovascular diseases and other organic diseases; Physical and chemical indexes of routine hematuria, ELECTROcardiogram, electroencephalogram, liver and kidney function, blood glucose and lipid were normal.
Patients with the above symptoms lasting more than 1 year and with frequency >= 3 times/week can only be included in this study.
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排除标准:
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如果受试者满足下列任何1项条件,其将不能参与此次试验。
1. 由于过度焦虑、抑郁等引起的失眠患者;
2. 患有呼吸相关的睡眠障碍,昼夜节律睡眠障碍和睡眠机能紊乱者;
3. 患全身性疾病,如疼痛、发热、咳嗽等,导致的失眠患者;
4. 合并有心血管、肺、肝、肾和造血系统等严重原发性疾病患者;
5. 精神性疾病患者;
6. 治疗部位皮肤有感染者或皮肤为超敏皮肤;
7. 进展性恶性肿瘤或其它严重消耗性疾病,易合并感染和出血者;
8. 依从性差,未按规定进行治疗的患者;
9. 因某种原因,导致无法判断疗效或资料不全等影响疗效和疗效判断者;
10. 由于滥用药物或药物治疗,引起是失眠患者;
11. 由长期过度饮酒、咖啡、浓茶等,及不良生活因素所致的睡眠障碍者;
12. 妊娠, 月经期或哺乳期妇女。
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Exclusion criteria:
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If a subject meets any of the following conditions, he/she will not be allowed to participate in the study.
1. Insomnia patients caused by excessive anxiety and depression;
2. Respiratory related sleep disorders, circadian rhythm sleep disorders and sleep disorders;
3. Insomnia patients suffering from systemic diseases such as pain, fever, cough, etc.;
4. Patients with cardiovascular, lung, liver, kidney, hematopoietic system and other serious primary diseases;
5. Patients with mental illness;
6. The skin at the treatment site is infected or hypersensitive;
7. Patients with progressive malignant tumors or other serious wasting diseases, which are prone to co-infection and bleeding;
8. Patients who have poor compliance, or fail to receive treatment as required;
9. For some reason, it is impossible to judge the curative effect or incomplete data affects the curative effect and judgement;
10. As a result of drug abuse or drug treatment, caused by insomnia patients;
11. Sleep disorders caused by long-term excessive drinking of alcohol, coffee, strong tea, etc., and adverse life factors;
12. A pregnant, menstruating, or lactating woman.
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研究实施时间:
Study execute time:
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从From
2022-05-01
至To
2023-12-31
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征募观察对象时间:
Recruiting time:
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从From
2022-05-01
至To
2023-12-31
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