Auricular Acupuncture vs. Progressive Muscle Relaxation in Patients With Anxiety Disorders or Major Depressive Disorder.
Auricular Acupuncture Versus Progressive Muscle Relaxation in Patients With Anxiety Disorders or Major Depressive Disorder.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
The purpose of this study is to determine whether auricular acupuncture according to the NADA protocol and progressive muscle relaxation differ in their effectiveness of treating people with anxiety disorders (AD) or major depressive disorder (MDD).
In this study, acupuncture was executed according to the NADA protocol: a standardized and comparable method of auricular acupuncture (AA) with ease of application and limited adverse reactions, which seems to have high acceptance among psychiatric patients. The NADA (National Acupuncture Detoxification Association) protocol includes the needling of five specific acupuncture points on both ears.
As a comparative relaxation treatment, progressive muscle relaxation (PMR) was applied in our study. It has been well established for many decades, especially for the treatment of severe states of physical and mental tension, which is a common symptom of anxiety disorders and depression. Many studies also suggest its potential utility in the treatment program of many other illnesses, which are associated with conditions of anxiety and depression, such as schizophrenia, sleeping disorders, endometriosis, atopic dermatitis or cancer.
The main aim of this study was to examine the effectiveness of AA according to the NADA protocol versus PMR in patients with AD or MDD. We hypothesized, that both treatments show significant effects in alleviating the examined items (tension, anxiety, anger/aggression and state ofr mood) and that there is no significant difference between these two treatments. In order to increase the patients´ treatment acceptance and compliance, this study was set up in an open design in which each patient was freely able to choose between both treatments.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- patient at our psychiatric ward or day-hospital
- meeting the DSM-IV diagnostic criteria for the primary diagnosis of an anxiety disorder oder major depressive disorder
Exclusion Criteria:
- ear infection
- anamnestic substance abuse or positive drug screening
- taking opioid analgesics
- suffering from schizophrenic or organic cerebral psychosis
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Нерандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Активный компаратор: Auricular acupuncture
Within this arm, patients were treated with auricular acupuncture according to the NADA protocol.
Each setting involved not more than eight patients at a time and was performed in a sitting position.
Each session lasted 30 minutes and took place twice a week over a period of 4 weeks.
|
Auricular acupuncture according to the the NADA protocol includes the needling of five specific acupuncture points on both ears: point 51 (= Sympathetic point), point 55 (= Shen Men), point 95 (= Kidney point), point 97 (= Liver point) and point 101 (= Lung point).
All points were acupunctured with fine sterile single use steel needles with the size of 0.25 x 20 millimetres.
The needles were inserted about 2-3 millimetres, so that the needle point pierces the skin and is just positioned in the cartilage of the ear.
They remained in position for 30 minutes.
|
|
Активный компаратор: Progressive muscle relaxation
Within this arm, patients were treated with who chose treatment with progressive muscle relaxation.
Each setting involved not more than eight patients at a time and was performed in a sitting position.
Each session lasted 30 minutes, took place twice a week over a period of 4 weeks.
|
Progressive muscle relaxation was carried out by the method of Bernstein and Borkovec.
All participants were asked to close eyes while sitting comfortably.
Each group session included 16 main exercises of consciously tensing and relaxing specific groups of muscles.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 1.
Временное ограничение: 1 week
|
VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.
|
1 week
|
|
Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 2.
Временное ограничение: week 2
|
VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.
|
week 2
|
|
Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 3.
Временное ограничение: week 3
|
VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.
|
week 3
|
|
Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 4.
Временное ограничение: week 4
|
VAS are rated as follows: ´tension´, ´anxiety´, ´anger/aggression´: VAS 0 = none, 100 = most imaginable; ´mood´: VAS 0 = bad, 100 = good.
|
week 4
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Соавторы и исследователи
Следователи
- Главный следователь: Christoph Muhtz, MD, Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf & Schoen Klinik Hamburg-Eilbek, Hamburg, Germany
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- UKE-Psych-Aku-08-14
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