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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-59f4yr |
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Date of registration:
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04/01/2012 |
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Primary sponsor: |
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Public title:
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Effect of acupuncture on anxiety in infertility women
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Scientific title:
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Effect of acupuncture on anxiety in women undergoing to in vitro fertilization |
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Date of first enrolment:
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01/04/2010 |
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Target sample size:
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43 |
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Recruitment status: |
data analysis completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-59f4yr/ |
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Study type:
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Study design:
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Clinical trial, randomized, one blinded, of parallel arms.
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Daniela
Isoyama |
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Address:
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Av. Príncipe de Gales, 821
09060-650
Santo André
Brazil |
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Telephone:
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55 11 87810910 |
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Email:
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daniela.isoyama@gmail.com |
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Affiliation:
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Serviço de Reprodução Humana - Faculdade de Medicina do ABC |
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Name:
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Daniela
Isoyama |
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Address:
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Av. Príncipe de Gales, 821
09060-650
Santo André
Brazil |
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Telephone:
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55 11 87810910 |
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Email:
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daniela.isoyama@gmail.com |
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Affiliation:
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Serviço de Reprodução Humana - Faculdade de Medicina do ABC |
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Key inclusion & exclusion criteria
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Inclusion criteria: Women newer than 45 years, without previous psychiatric disorders, without use of antidepressants and / or anxiolytics and without use of acupuncture before.
Exclusion criteria: Women older than 45 years, previous psychiatric disorders, use of antidepressants and / or anxiolytics and use of acupuncture before.
Age minimum:
20Y
Age maximum:
45Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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Anxiety in infertility women undergoing to in vitro fertilization. C13.351.500.365.700 F01.470.132
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N00-N99
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Intervention(s)
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The patients were randomly divided into two groups, the group that received traditional acupuncture treatment during the stages of IVF (Test Group), composed of 22 patients, and the control group, composed of 21 patients, and needles were inserted in areas not corresponding to points of Acupuncture.
For each patient was performed a total of four sessions at weekly intervals (period which comprised the whole IVF process, from ovulation induction to the result of ?HCG). All sessions, both traditional acupuncture and placebo were performed by the same professional acupuncturist. For the Test group were chosen points in the forearm, chest, face and apex of the head. These regions correspond to C7 and CS6 points on forearm (bilaterally), VC17 on chest, M-CP-3 on the face and VG20 at the apex of head.8, 9 In the Control group the same number of needles was placed in the same regions, but at a distance of approximately 1.2 cm, in regions certainly do not correspondent to known acupuncture points. It was used in all cases and points Dong Bang® 25x40mm Korean needle with stainless steel spiral cord. After the four weekly sessions all patients returned to the researcher for reapplication of the Anxiety assessment questionnaire and final evaluation
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Primary Outcome(s)
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The primary endpoint was reduction of at least 30% score on the Hamilton scale when assessed after treatment.
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Secondary Outcome(s)
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To assess whether the reduction of anxiety reflected in an increase in pregnancy rate.
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Source(s) of Monetary Support
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Serviço de Reprodução Humana - Faculdade de Medicina do ABC - Brazil
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