Vital Signs and Pain During Insertion of IUD

Federal University of São Paulo

Status: Completed

Conditions: Contraception; Acute Pain

Treatments: Procedure: Evaluation of blood pressure; Procedure: Evaluation of radial pulse; Behavioral: Application of the Visual Analog Scale of pain

Study type: Observational

Funder types: Other

Identifiers

NCT02461862

Nº CEP: 0272/2015

Details and patient eligibility

About

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

Full 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.

Enrollment: 285 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

285 participants in 1 patient group

Intra Uternine Device

Description:

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.

Treatment:

Behavioral: Application of the Visual Analog Scale of pain

Procedure: Evaluation of radial pulse

Procedure: Evaluation of blood pressure