Study Results
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Basic Information
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COMPLETED
285 participants
OBSERVATIONAL
2015-01-31
2015-05-31
Brief Summary
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Detailed Description
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Objective: To evaluate the intensity of pain on outpatient insertion of IUD. In addition to evaluating changes in vital signs and detect which are the factors associated with pain on outpatient insertion of IUD. Methods: Cross Sectional Retrospective study of 285 procedures of outpatient insertion of IUD.
Inclusion criteria were age older than 18 years, cervical cytology without abnormalities, classification for Category 1 or 2 of the WHO eligibility criteria for IUD. The criteria for non inclusion were patients with cardiac arrhythmias and gynecological disorders. The insertions of IUD were conducted on an outpatient basis without the use of painkillers.
Evaluation of vital signs ( blood pressure and radial pulse) was performed pre and five minutes after the procedure. The pain assessment was performed using the scale visual analog (VAS), five minutes after the procedure.Correlations of the pain's score with clinical factors as age, parity, BMI, hysterometry, previous vaginal delivery were also performed.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Intra Uternine Device
Women who came to the medical service, to insert an intra uterine Device (IUD) of Cu or a Levonorgestrel Intra Uterine System( Lng- IUS) after have been attended in the Family Planning Service of Federal University of São Paulo . All patient have had the pain evaluated by Application of the Visual Analog Scale of Pain (VAS), and also their vital signs ( Evaluation of blood pressure,Evaluation of radial pulse) evaluated pre and five minutes after the IUD/ IUS insertion.
Application of the Visual Analog Scale of pain
Evaluation of pain previous and 5 minutes after outpatient insertion of IUD / IUS using the Visual Analog Scale of Pain
Evaluation of blood pressure
Evaluation of Blood pressure ( mmHg), previous and 5 minutes after outpatient insertion of IUD / IUS by sphygmomanometer.
Evaluation of radial pulse
Evaluation of radial pulse (beats per minute) previous and 5 minutes after outpatient insertion of IUD / IUS by pulse oximetry
Interventions
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Application of the Visual Analog Scale of pain
Evaluation of pain previous and 5 minutes after outpatient insertion of IUD / IUS using the Visual Analog Scale of Pain
Evaluation of blood pressure
Evaluation of Blood pressure ( mmHg), previous and 5 minutes after outpatient insertion of IUD / IUS by sphygmomanometer.
Evaluation of radial pulse
Evaluation of radial pulse (beats per minute) previous and 5 minutes after outpatient insertion of IUD / IUS by pulse oximetry
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* cytology without abnormalities
* classification for Category 1 or 2 of the WHO eligibility criteria for IUD / IUS.
Exclusion Criteria
* gynecological disorders
18 Years
60 Years
FEMALE
No
Sponsors
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Federal University of São Paulo
OTHER
Responsible Party
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Ana Maria Homem de Mello Bianchi
PHD
Principal Investigators
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Zsuzsanna IK Jarmy di Bella
Role: STUDY_CHAIR
Federal University of São Paulo
Other Identifiers
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Nº CEP: 0272/2015
Identifier Type: -
Identifier Source: org_study_id
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