Vital Signs and Pain During Insertion of IUD

Last updated: June 1, 2015
Sponsor: Federal University of São Paulo
Overall Status: Completed

Phase

N/A

Condition

Contraception

Pain

Acute Pain

Treatment

N/A

Clinical Study ID

NCT02461862
Nº CEP: 0272/2015
  • Ages 18-60
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • patients with cardiac arrhythmias

  • gynecological disorders

Study Design

Total Participants: 285
Study Start date:
January 01, 2015
Estimated Completion Date:
May 31, 2015

Study 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.