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Trial registered on ANZCTR


Registration number
ACTRN12611000113954
Ethics application status
Approved
Date submitted
29/01/2011
Date registered
1/02/2011
Date last updated
1/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of acupuncture on the anxious and depressive symptoms occasioned by the Premenstrual Dysphoric Disorder.
Scientific title
Effects of acupuncture on the anxious and depressive symptoms occasioned by the Premenstrual Dysphoric Disorder - Randomized clinical trial.
Secondary ID [1] 253522 0
"Nil".
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premenstrual Dysphoric Disorder (PMDD). 261049 0
Anxious symptoms. 261050 0
Depressive symptoms. 261051 0
Condition category
Condition code
Alternative and Complementary Medicine 259192 259192 0 0
Other alternative and complementary medicine
Mental Health 259193 259193 0 0
Depression
Mental Health 259194 259194 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acupuncture:Using needles Korean brand Dongbang size 0,20 X 30 mm. Needles for single use, discarded in an appropriate container (BD Descartex - Registered Trademark (R)) after use, not being reused.
We used a cube of foam about 2 cm with an adhesive material (double-sided tape) covering one side of the cube, which was placed on the skin over the acupuncture point, making support for the acupuncture needle. The volunteer was not able to see the level of needle entry, because the cube impeded vision. The needle penetrated the skin enough to reach the acupoint and give the effect "DE QI ".
Used acupoints: PC-6, TE-5, LI-4, GB-34, SP-6 and LR-3.
Frequency of twice a week for two menstrual cycles (based on the normal cycle of 28 days), totaling 16 sessions. The duration of each service, with initial treatments, application of needles and the needles stay was around 45 minutes.
Intervention code [1] 257935 0
Treatment: Other
Comparator / control treatment
Acupuncture Sham: Using needles Korean brand Dongbang size 0,20 X 40 mm. Needles for single use, discarded in an appropriate container (BD Descartex - Registered Trademark (R)) after use, not being reused.
In this group, the volunteers received the sham acupuncture into non-acupoints, utilizing location two centimeters to either side of the acupoints used. We used the same technique described in the acupuncture group, but the puncture was performed 02 mm and the needle was withdrawn quickly, not reaching effect "De Qi". Furthermore, the needle was retained in the foam cube, which gave the impression that she remained on the skin. The needle of this group was smaller than the acupuncture group, to ensure that the needle shaft of the two groups stayed the same distance off the cube.
Frequency of twice a week for two menstrual cycles (based on the normal cycle of 28 days), totaling 16 sessions. The duration of each service, with initial treatments, application of needles and the needles stay was around 45 minutes.
Control group
Placebo

Outcomes
Primary outcome [1] 262042 0
Analysis of changes in anxiety symptoms with the Hamilton Anxiety Scale.
Timepoint [1] 262042 0
At baseline and at 4 and 8 weeks after intervention commencement.
Primary outcome [2] 262043 0
Analysis of variation in depressive symptoms with the Hamilton Depression Scale.
Timepoint [2] 262043 0
At baseline and at 4 and 8 weeks after intervention commencement.
Primary outcome [3] 262044 0
Analysis of variation in quality of life with the Brazilian version of the SF-36 questionnaire.
Timepoint [3] 262044 0
At baseline and at 4 and 8 weeks after intervention commencement.
Secondary outcome [1] 273020 0
To characterize the profile of women evaluated with premenstrual dysphoric disorder through an evaluation form with questions about socio-demographic profile.
Timepoint [1] 273020 0
At 2 months after randomisation.
Secondary outcome [2] 273021 0
Assess for any subgroup with better response to acupuncture treatment.
Subgroups: age between 18 and 28 years, age between 29 to 42 years and physical activity.
Timepoint [2] 273021 0
At 2 months after randomisation.

Eligibility
Key inclusion criteria
Women of childbearing age, with regular menstrual cycles and with a diagnosis of premenstrual dysphoric disorder confirmed by the DSM-IV
Minimum age
18 Years
Maximum age
42 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, irregular menstrual cycles (cycles longer than 35 days and less than 25), use of hormonal contraceptives, diuretics and psychiatric medications (psychotropic drugs, tricyclic antidepressants and serotonin reuptake inhibitors), use of NSAIDs chronically have had diagnosis of depression and anxiety for 2 years (not linked to the diagnosis of PMDD), to be performing any kind of treatment for decreasing symptoms of PMDD, have experienced acupuncture treatment at any time, regardless of the reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using randomization procedure by consecutive sampling systematically in order of arrival. The patients were unique for the acupuncture group and the patients peers for sham acupuncture group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 3163 0
Brazil
State/province [1] 3163 0
Parana

Funding & Sponsors
Funding source category [1] 258403 0
Self funded/Unfunded
Name [1] 258403 0
Fabiana Carvalho
Address [1] 258403 0
Avenida Tarquinio Joslin dos Santos numero 1000.
Bairro Jardim Universitario.
CEP: 85870-901
Foz do Iguacu - Parana
Country [1] 258403 0
Brazil
Primary sponsor type
Individual
Name
Fabiana Carvalho
Address
Avenida Tarquinio Joslin dos Santos numero 1000.
Bairro Jardim Universitario.
CEP: 85870-901
Foz do Iguacu - Parana
Country
Brazil
Secondary sponsor category [1] 257551 0
Individual
Name [1] 257551 0
Maristela de Souza Rabbo Padilha
Address [1] 257551 0
Centro Universitario Metodista do Sul
Pro-Reitoria de Pesquisa e Pos-Graduacao - PRPPG
Programa de Pos-Graduacao em Reabilitacao e Inclusao
Rua Cel. Joaquim Pedro Salgado, 80 - Bairro Rio Branco
90240-060 - Porto Alegre - RS
Country [1] 257551 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260376 0
Comite de etica em pesquisa do Centro Universitario Metodista do Sul
Ethics committee address [1] 260376 0
Rua Cel. Joaquim Pedro Salgado, 80 - Bairro Rio Branco
90240-060 - Porto Alegre - RS
Ethics committee country [1] 260376 0
Brazil
Date submitted for ethics approval [1] 260376 0
Approval date [1] 260376 0
04/09/2009
Ethics approval number [1] 260376 0
287/2009

Summary
Brief summary
The objective of this research is to evaluate the effects of acupuncture in the anxious and depressive symptoms occasioned by the Premenstrual Dysphoric Disorder.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32146 0
Address 32146 0
Country 32146 0
Phone 32146 0
Fax 32146 0
Email 32146 0
Contact person for public queries
Name 15393 0
Fabiana Carvalho
Address 15393 0
Faculdade Uniao das Americas
Avenida Tarquinio Joslin dos Santos, 1000.
Bairro: Jardim Universitario.
CEP: 85870-901
Foz do Iguacu - Parana
Country 15393 0
Brazil
Phone 15393 0
+55 (45) 3025.5071 / +55 (45) 9124.1109
Fax 15393 0
Email 15393 0
fabianacarvalho@uniamerica.br / fabi@cybermais.net
Contact person for scientific queries
Name 6321 0
Fabiana Carvalho
Address 6321 0
Faculdade Uniao das Americas
Avenida Tarquinio Joslin dos Santos, 1000.
Bairro: Jardim Universitario.
CEP: 85870-901
Foz do Iguacu - Parana
Country 6321 0
Brazil
Phone 6321 0
+55 (45) 3025.5071 / +55 (45) 9124.1109
Fax 6321 0
Email 6321 0
fabianacarvalho@uniamerica.br / fabi@cybermais.net

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary