- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02461862
Vital Signs and Pain During Insertion of IUD
Assessment of Vital Signs and Pain During Insertion of Intra Uterine Device
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
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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.
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Evaluation of pain previous and 5 minutes after outpatient insertion of IUD / IUS using the Visual Analog Scale of Pain
Inne nazwy:
Evaluation of Blood pressure ( mmHg), previous and 5 minutes after outpatient insertion of IUD / IUS by sphygmomanometer.
Inne nazwy:
Evaluation of radial pulse (beats per minute) previous and 5 minutes after outpatient insertion of IUD / IUS by pulse oximetry
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Evaluation of pain after insertion of IUD/IUS
Ramy czasowe: 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
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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
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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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Evaluation of blood pressure modification after insertion of IUD/IUS
Ramy czasowe: Duration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertion
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Evaluation of blood pressure (mmHg) using a Sphygmomanometer, before and five minutes after the insertion of the IUD/IUS
|
Duration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertion
|
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Evaluation of clinical factors that may interfere with the intensity of pain
Ramy czasowe: 1 day
|
Correlate the pain score of VAS with clinical factors as age, parity, BMI, hysterometry, previous vaginal delivery
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1 day
|
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Evaluation of radial pulse modification after insertion of IUD/IUS
Ramy czasowe: 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
|
Duration 15 minutes - two evaluations: before the procedure and five minutes immediately after IUD/IUS insertion
|
Współpracownicy i badacze
Sponsor
Śledczy
- Krzesło do nauki: Zsuzsanna IK Jarmy di Bella, Federal University of São Paulo
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Nº CEP: 0272/2015
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