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Vital Signs and Pain During Insertion of IUD

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02461862
Enrollment
285
Registered
2015-06-03
Start date
2015-01-31
Completion date
2015-05-31
Last updated
2015-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Contraception

Keywords

Contraception, Contraception Behavior, Intra uterine device, Intra uterine System, IUD, IUS, Acute Pain

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.

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.

Interventions

BEHAVIORALApplication 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

PROCEDUREEvaluation of blood pressure

Evaluation of Blood pressure ( mmHg), previous and 5 minutes after outpatient insertion of IUD / IUS by sphygmomanometer.

PROCEDUREEvaluation of radial pulse

Evaluation of radial pulse (beats per minute) previous and 5 minutes after outpatient insertion of IUD / IUS by pulse oximetry

Sponsors

Federal University of São Paulo
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of pain after insertion of IUD/IUSSingle 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 momentAssessment 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

MeasureTime frameDescription
Evaluation of blood pressure modification after insertion of IUD/IUSDuration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertionEvaluation of blood pressure (mmHg) using a Sphygmomanometer, before and five minutes after the insertion of the IUD/IUS
Evaluation of clinical factors that may interfere with the intensity of pain1 dayCorrelate the pain score of VAS with clinical factors as age, parity, BMI, hysterometry, previous vaginal delivery
Evaluation of radial pulse modification after insertion of IUD/IUSDuration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertionEvaluation of radial pulse ( beats per minute) using a pulse oximeter before and five minutes after the insertion of the IUD/IUS

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026