Assessment of Vital Signs and Pain During Insertion of Intra Uterine Device
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 285
- Primary Endpoint
- Evaluation of pain after insertion of IUD/IUS
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
Evaluation of pain after insertion of IUD/IUS
Time Frame: 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
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
Secondary Outcomes
- Evaluation of blood pressure modification after insertion of IUD/IUS(Duration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertion)
- Evaluation of clinical factors that may interfere with the intensity of pain(1 day)
- Evaluation of radial pulse modification after insertion of IUD/IUS(Duration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertion)
Investigators
Ana Maria Homem de Mello Bianchi
PHD
Federal University of São Paulo