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Vital Signs and Pain During Insertion of IUD

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ClinicalTrials.gov Identifier: NCT02461862
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
Ana Maria Homem de Mello Bianchi, Federal University of São Paulo

Brief Summary:
Cross-sectional cohort study to evaluating pain and vital signs variations (blood pressure and radial pulse) during the placement of the intrauterine device.

Condition or disease Intervention/treatment
Contraception Acute Pain Behavioral: Application of the Visual Analog Scale of pain Procedure: Evaluation of blood pressure Procedure: Evaluation of radial pulse

Detailed Description:

The intrauterine device (IUD), which is one of the most effective and safe contraceptives is still little used by women. It is considered a long action reversible contraception (LARC). Among the many reasons for this resistance stands the fear of pain, the complications that can occur during the insertion.

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.


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Study Type : Observational
Actual Enrollment : 285 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Assessment of Vital Signs and Pain During Insertion of Intra Uterine Device
Study Start Date : January 2015
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vital Signs

Group/Cohort Intervention/treatment
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.
Behavioral: 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
Other Name: VAS

Procedure: Evaluation of blood pressure
Evaluation of Blood pressure ( mmHg), previous and 5 minutes after outpatient insertion of IUD / IUS by sphygmomanometer.
Other Name: BP evaluation

Procedure: 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 Name: Pulse evaluation




Primary Outcome Measures :
  1. Evaluation of pain after insertion of IUD/IUS [ Time Frame: Single evaluation after 5 minutes of the insertion of the IUD/IUS ( the evaluation takes 1 minute- choose a number on visual analog scale of pain that represents the pain of that moment ]
    Assessment of pain five minutes immediately after IUD/IUS insertion using the visual analog scale - choose a number on visual analog scale of pain that represents the pain of that moment


Secondary Outcome Measures :
  1. Evaluation of blood pressure modification after insertion of IUD/IUS [ Time Frame: Duration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertion ]
    Evaluation of blood pressure (mmHg) using a Sphygmomanometer, before and five minutes after the insertion of the IUD/IUS

  2. Evaluation of clinical factors that may interfere with the intensity of pain [ Time Frame: 1 day ]
    Correlate the pain score of VAS with clinical factors as age, parity, BMI, hysterometry, previous vaginal delivery

  3. Evaluation of radial pulse modification after insertion of IUD/IUS [ Time Frame: Duration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertion ]
    Evaluation of radial pulse ( beats per minute) using a pulse oximeter before and five minutes after the insertion of the IUD/IUS



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women that attended to clinical visit to insertion of IUD
Criteria

Inclusion Criteria:

  • age older than 18 years
  • cytology without abnormalities
  • classification for Category 1 or 2 of the WHO eligibility criteria for IUD / IUS.

Exclusion Criteria:

  • patients with cardiac arrhythmias
  • gynecological disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02461862


Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Study Chair: Zsuzsanna IK Jarmy di Bella Federal University of São Paulo

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Responsible Party: Ana Maria Homem de Mello Bianchi, PHD, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02461862     History of Changes
Other Study ID Numbers: Nº CEP: 0272/2015
First Posted: June 3, 2015    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by Ana Maria Homem de Mello Bianchi, Federal University of São Paulo:
Contraception
Contraception Behavior
Intra uterine device
Intra uterine System
IUD
IUS
Acute Pain

Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms