ContraceptionNCT02461862
Vital Signs and Pain During Insertion of IUD
An observational study of Contraception and Acute Pain, run by Federal University of São Paulo.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Contraception, Acute Pain
- What is being tested?
- Application of the Visual Analog Scale of pain, Evaluation of blood pressure and Evaluation of radial pulse
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 285 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: Women that attended to clinical visit to insertion of IUD
Who may be able to join
- age older than 18 years
- cytology without abnormalities
- classification for Category 1 or 2 of the WHO eligibility criteria for IUD / IUS.
Who cannot join
- patients with cardiac arrhythmias
- gynecological disorders
About this study
Official title: Assessment of Vital Signs and Pain During Insertion of Intra Uterine Device
Cross-sectional cohort study to evaluating pain and vital signs variations (blood pressure and radial pulse) during the placement of the intrauterine device.
Read the 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.
- Conditions
- Contraception, Acute Pain
- Being tested
- Application of the Visual Analog Scale of pain, Evaluation of blood pressure, Evaluation of radial pulse
- Keywords
- Contraception, Contraception Behavior, Intra uterine device, Intra uterine System, IUD, IUS, Acute Pain
- Medical subject headings
- Acute Pain, Contraception Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of the Visual Analog Scale of painBehavioural
Also called VAS
Evaluation of pain previous and 5 minutes after outpatient insertion of IUD / IUS using the Visual Analog Scale of Pain
Evaluation of blood pressureProcedure or surgery
Also called BP evaluation
Evaluation of Blood pressure ( mmHg), previous and 5 minutes after outpatient insertion of IUD / IUS by sphygmomanometer.
Evaluation of radial pulseProcedure or surgery
Also called Pulse evaluation
Evaluation of radial pulse (beats per minute) previous and 5 minutes after outpatient insertion of IUD / IUS by pulse oximetry
| Study group | Role | What they receive |
|---|---|---|
| Intra Uternine Device | Women who came to the medical service, to insert an intra uterine Device (IUD) of Cu or a Levonorgestrel Intra Uterine System( Lng- IUS) after have been attended in the Family Planning Service of Federal University of São Paulo . All patient have had the pain evaluated by Application of the Visual Analog Scale of Pain (VAS), and also their vital signs ( Evaluation of blood pressure,Evaluation of radial pulse) evaluated pre and five minutes after the IUD/ IUS insertion. Receives: Behavioral: Application of the Visual Analog Scale of pain; Procedure: Evaluation of blood pressure; Procedure: Evaluation of radial pulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 (3)
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
Measured: 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
Correlate the pain score of VAS with clinical factors as age, parity, BMI, hysterometry, previous vaginal delivery
Measured: 1 day
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
Measured: Duration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Maria Homem de Mello Bianchi, Federal University of São Paulo
- Investigators
- Zsuzsanna IK Jarmy di Bella, Study chair, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461862
- Sponsor's protocol ID
- Nº CEP: 0272/2015
- Status last verified
- Jun 2015
- First submitted
- 25 May 2015
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Vital Signs and Pain During Insertion of Intra Uterine Device
- ClinicalTrials.gov ID
- NCT02461862
- Acronym / sponsor ID
- Nº CEP: 0272/2015
- Conditions
- Contraception, Acute Pain
- Keywords
- Contraception, Contraception Behavior, Intra uterine device, Intra uterine System, IUD, IUS, Acute Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 3 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra Uternine Device | – | Behavioral: Application of the Visual Analog Scale of pain, Procedure: Evaluation of blood pressure, Procedure: Evaluation of radial pulseWomen who came to the medical service, to insert an intra uterine Device (IUD) of Cu or a Levonorgestrel Intra Uterine System( Lng- IUS) after have been attended in the Family Planning Service of Federal University of São Paulo . All patient have had the pain evaluated by Application of the Visual Analog Scale of Pain (VAS), and also their vital signs ( Evaluation of blood pressure,Evaluation of radial pulse) evaluated pre and five minutes after the IUD/ IUS insertion. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women that attended to clinical visit to insertion of IUD
Key inclusion criteria (3 listed)
- age older than 18 years
- cytology without abnormalities
- classification for Category 1 or 2 of the WHO eligibility criteria for IUD / IUS.
Key exclusion criteria (2 listed)
- patients with cardiac arrhythmias
- gynecological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of the Visual Analog Scale of painAlso: VASEvaluation of pain previous and 5 minutes after outpatient insertion of IUD / IUS using the Visual Analog Scale of Pain | Behavioural | Intra Uternine Device |
| Evaluation of blood pressureAlso: BP evaluationEvaluation of Blood pressure ( mmHg), previous and 5 minutes after outpatient insertion of IUD / IUS by sphygmomanometer. | Procedure or surgery | Intra Uternine Device |
| Evaluation of radial pulseAlso: Pulse evaluationEvaluation of radial pulse (beats per minute) previous and 5 minutes after outpatient insertion of IUD / IUS by pulse oximetry | Procedure or surgery | Intra Uternine Device |
Primary outcome
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
3 secondary outcomes
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 clinical factors that may interfere with the intensity of pain
Time frame: 1 day
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zsuzsanna IK Jarmy di Bella study chair
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
An observational study of Contraception and Acute Pain, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.