Clinical trial NCT02461862: Vital Signs and Pain During Insertion of IUD
Official title: Assessment of Vital Signs and Pain During Insertion of Intra Uterine Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Acute Pain
Keywords: Contraception
Contraception Behavior
Intra uterine device
Intra uterine System
IUD
IUS
Acute Pain
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2015-06-03
Enrollment: 285
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women that attended to clinical visit to insertion of IUD

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.

Eligibility 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

Primary outcomes:
measure: Evaluation of pain after insertion of IUD/IUS
timeFrame: 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
Secondary outcomes:
measure: Evaluation of blood pressure modification after insertion of IUD/IUS
timeFrame: Duration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertion
measure: Evaluation of clinical factors that may interfere with the intensity of pain
timeFrame: 1 day
measure: Evaluation of radial pulse modification after insertion of IUD/IUS
timeFrame: Duration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertion
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Zsuzsanna IK Jarmy di Bella
role: STUDY_CHAIR
References: