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Completed

NCT Number: NCT02461862

Vital Signs and Pain During Insertion of IUD

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Application of the Visual Analog Scale of pain

Behavioral

Evaluation of pain previous and 5 minutes after outpatient insertion of IUD / IUS using the Visual Analog Scale of Pain

Other names: VAS

Evaluation of blood pressure

Procedure

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

Other names: BP evaluation

Evaluation of radial pulse

Procedure

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

Other names: Pulse evaluation

Primary outcomes

  1. 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

  1. Evaluation of blood pressure modification after insertion of IUD/IUS

    Time frame: Duration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertion

    Evaluation of blood pressure (mmHg) using a Sphygmomanometer, before and five minutes after the insertion of the IUD/IUS

  2. Evaluation of clinical factors that may interfere with the intensity of pain

    Time frame: 1 day

    Correlate the pain score of VAS with clinical factors as age, parity, BMI, hysterometry, previous vaginal delivery

  3. Evaluation of radial pulse modification after insertion of IUD/IUS

    Time frame: Duration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertion

    Evaluation of radial pulse ( beats per minute) using a pulse oximeter before and five minutes after the insertion of the IUD/IUS

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 3, 2015
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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