Vital Signs and Pain During Insertion of IUD

Contraception Clinical Trial

Official title:

Assessment of Vital Signs and Pain During Insertion of Intra Uterine Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461862
• Other study ID #: Nº CEP: 0272/2015
• Status: Completed
• Phase: N/A
• First received: May 25, 2015
• Last updated: June 1, 2015
• Start date: January 2015
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Pain
• Contraception

Intervention

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

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of pain after insertion of IUD/IUS	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	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	Yes
Secondary	Evaluation of blood pressure modification after insertion of IUD/IUS	Evaluation of blood pressure (mmHg) using a Sphygmomanometer, before and five minutes after the insertion of the IUD/IUS	Duration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertion	Yes
Secondary	Evaluation of clinical factors that may interfere with the intensity of pain	Correlate the pain score of VAS with clinical factors as age, parity, BMI, hysterometry, previous vaginal delivery	1 day	Yes
Secondary	Evaluation of radial pulse modification after insertion of IUD/IUS	Evaluation of radial pulse ( beats per minute) using a pulse oximeter before and five minutes after the insertion of the IUD/IUS	Duration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertion	Yes