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حالة التجربة السريرية NCT07183813 لـ القلق والاكتئاب، سرطان الثدي، الوخز بالإبر هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا.
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث

الوخز بالإبر للقلق/الاكتئاب لدى مرضى سرطان الثدي ٣٦٠

لم يبدأ القبول بعد
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07183813 هي دراسة تدخُّلية لـالقلق والاكتئاب، سرطان الثدي، الوخز بالإبر وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ٢٣ ربيع الأول ١٤٤٧ هـ لتجنيد ٣٦٠ مشاركًا. يقودها Guang'anmen Hospital of China Academy of Chinese Medical Sciences، ومن المتوقع اكتمالها بحلول ٢١ رجب ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٢ ربيع الآخر ١٤٤٧ هـ.
الملخص
The aim of this study is to evaluate the effects and safety of acupuncture on anxiety and/or depression among patients with breast cancer.
العنوان الرسمي

Effects of Acupuncture for Anxiety and/or Depression Among Patients With Breast Cancer

الحالات الطبية
القلق والاكتئابسرطان الثديالوخز بالإبر
معرّفات دراسة أخرى
  • 2025-075-KY-01
NCT معرّف
NCT07183813
تاريخ البدء (فعلي)
2025-09-15
آخر تحديث مُنشور
2025-09-24
تاريخ الاكتمال (المقدر)
2026-12-30
عدد المشاركين المخطط لهم
٣٦٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ القبول بعد
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
ثلاثي
مجموعات/التدخلات
مجموعة المشاركين/الذراعالتدخل/العلاج
تجريبيةElectroacupuncture group
Acupoints:Bai Hui acupoint, An Mian acupoint, Shang Yin Tang acupoint, Tai Yang acupoint, Tian Shu acupoint, Zu SanLi acupoint, Tai Chong acupoint, Shen Men acupoint.
مجموعة الوخز بالإبر الكهربائية
The needles will be inserted to 15-40mm in acupoints through adhesive pads. Needles will be lifted, thrusted and twirled gently for 3 times to achieve deqi sensation and manipulated every ten minutes during 30-minute maintenance. The electronic acupuncture apparatus will be connected to the bileteral Taiyang, Anmian and Baihui, with a continuous wave of 2 Hertz (Hz) and an electric current of 1-3 milliampere (mA). Pa...عرض المزيد
المقارن الزائفSham electroacupuncture (SEA) group
Acupoints: Bai Hui acupoint, An Mian acupoint, Shang Yin Tang acupoint, Tai Yang acupoint, Tian Shu acupoint, Zu San Li acupoint, Tai Chong acupoint, Shen Men acupoint.
العلاج بالإبر الكهربائية الوهمية
The needle will be inserted to 2-3mm in Bai Hui acupoint. For the remaining acupoints, needles will be inserted into the pad till reaching but without penetrating the skin. Needles will be lifted, thrusted and twirled gently for 3 times to simulate the effects of the needle tip penetrating the skin. The electronic acupuncture apparatus will be connected to the Baihui acupoint, Shang Yin Tang acupoint, and bilateral A...عرض المزيد
النتيجة الرئيسية
مقياس النتيجةوصف القياسالإطار الزمني
The change from baseline in the total score of Hospital Anxiety and Depression Scale (HADS).
The total score of HADS ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
week 8
النتيجة الثانوية
مقياس النتيجةوصف القياسالإطار الزمني
The change from baseline in the total score of HADS.
The total score of HADS ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
weeks 4, 12, 16 and 20
The change from baseline in the score of HADS-A and HADS-D
The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
weeks 4, 8, 12, 16 and 20
Proportion of participants with a total HADS score less than 15, an HADS-A score of less than or equal to 7, and an HADS-D score of less than or equal to 7
The HADS score ranges from 0 to 42, with higher scores indicating greater anxiety and depression.
weeks 4, 8, 12, 16 and 20
Change from baseline in Hamilton Depression Scale-14
The Hamilton Depression Scale (HAMD) was developed by Hamilton in 1959 and is a clinical tool used to assess anxiety symptoms. All items use a 5-point rating scale from 0 to 4, with a total score ranging from 0 to 56. The cut-off value is 14 points. Generally, a score of \>14 points indicates anxiety, \>29 points indicates severe anxiety, and the higher the score, the more severe the anxiety symptoms.
Week 4, 8 and 20
Change from baseline in Hamilton Depression Scale-17
The Hamilton Depression Scale (HAMD) was developed by Hamilton in 1960 and is the most commonly used scale in clinical assessment of depressive states. All items are scored on a 5-point scale ranging from 0 to 4. The total score is 68. A score of 8-17 indicates mild depression, 18-24 indicates moderate depression, and a score of ≥25 indicates severe depression.
Week 4, 8 and 20
The change from baseline in the Functional Assessment of Cancer Therapy- General and the Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B)
The FACT-B is a specific scale designed to measure the quality of life in breast cancer patients. The total score of the questionnaire range from 0 to 144, with higher scores indicating worse quality of life.
weeks 4,8 and 20
The change from baseline in the Fear of Cancer Recurrence Inventory-short form(FCRI-SF)
The FCRI-SF score ranges from 0 to 168, with higher scores indicating a higher level of fear of cancer recurrence among cancer patients.
weeks 4, 8 and 20
The change from baseline in the brief fatigue inventory (BFI)
The BFI score ranges from 0 to 10, with higher scores indicating greater fatigue.
weeks 4, 8 and 20
The change from baseline in the Insomnia Severity Index (ISI)
The ISI score ranges from 0 to 28, with higher scores indicating Insomnia Severity.
weeks 4, 8 and 20
The proportion of responders per the Patient Global Index of Improvement (PGI-I)
The PGI-I evaluates the overall treatment effect perceived by patients themselves. The change can be rated in 7 levels, including "very much better", "much better", "a little better", "no change", "a little worse", "much worse" or "very much worse". The score of the scale ranges from 1 to 7.
weeks 8 and 20
Collection of cranial MRI images.
Data were acquired at the Department of Radiology using a Magneton Skyra 3.0 T MR scanner.
baseline and week 8
مساعد المشاركة
معايير الأهلية

الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
أنثى
يقبل المتطوعين الأصحاء
نعم
  1. Female, aged 18 to 70 years old;
  2. Meeting the diagnostic criteria for breast cancer and at TMN I-III;
  3. Having completed specialized active treatment for at least one month;
  4. With an ECOG score of 0-2;
  5. Mild to moderate anxiety and/or depression;
  6. Voluntarily joining this study and signing the informed consent form.

  1. Starting to take or change the regimen of anti-anxiety and/or -depression disorder medication within one month before enrolment;
  2. Received psychological intervention or physical therapy one month before enrolment or planning to use in the next 5 months;
  3. With diagnosis of anxiety and/or depression disorder prior to the diagnosis of breast cancer;
  4. Patients with suicidal tendencies, bipolar disorder and psychotic symptoms;
  5. Patients with severe anxiety and/or depression；
  6. Patients received acupuncture treatment within one month before enrolment;
  7. Participating in other clinical studies on the treatment of anxiety and/or depression;
  8. Combined with severe underlying diseases;
  9. Patients with severe skin ulcers;
  10. Pregnant or lactating patients;
  11. Poor compliance.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences logoGuang'anmen Hospital of China Academy of Chinese Medical Sciences
الجهة المسؤولة عن الدراسة
Yuanjie Sun, المحقق الرئيسي, Attending physician, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
جهة اتصال مركزية للدراسة
جهة اتصال: Yuanjie Sun, +8618810337542, [email protected]
جهة اتصال: Shuai Gao, +8613128205732, [email protected]
1 مواقع الدراسة في 1 بلدان
Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing, China
Yuanjie Sun, جهة اتصال, 86 18810337542, [email protected]