Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Auricular Acupuncture vs. Progressive Muscle Relaxation in Patients With Anxiety Disorders or Major Depressive Disorder.

15 januari 2015 bijgewerkt door: Universitätsklinikum Hamburg-Eppendorf

Auricular Acupuncture Versus Progressive Muscle Relaxation in Patients With Anxiety Disorders or Major Depressive Disorder.

The purpose of this study is to determine whether auricular acupuncture (AA) according to the NADA protocol and progressive muscle relaxation (PMR) differ in their effectiveness of treating people with anxiety disorders or major depressive disorder. 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

136

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Apparaat: Auricular acupuncture
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.
Actieve vergelijker: 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.
Procedure: Progressive muscle relaxation
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean VAS scores of anxiety, tension, anger/aggression and mood before and after treatment within each treatment group at week 1.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Onderzoekers

  • Hoofdonderzoeker: Christoph Muhtz, MD, Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf & Schoen Klinik Hamburg-Eilbek, Hamburg, Germany

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 juli 2007

Primaire voltooiing (Werkelijk)

1 maart 2009

Studie voltooiing (Werkelijk)

1 augustus 2013

Studieregistratiedata

Eerst ingediend

13 januari 2015

Eerst ingediend dat voldeed aan de QC-criteria

15 januari 2015

Eerst geplaatst (Schatting)

16 januari 2015

Updates van studierecords

Laatste update geplaatst (Schatting)

16 januari 2015

Laatste update ingediend die voldeed aan QC-criteria

15 januari 2015

Laatst geverifieerd

1 januari 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UKE-Psych-Aku-08-14

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Angst stoornissen

Klinische onderzoeken op Auricular acupuncture

Zoek naar vergelijkbare onderzoeken

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Paraguay

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

3
Abonneren