Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Vital Signs and Pain During Insertion of IUD

1. juni 2015 opdateret af: Ana Maria Homem de Mello Bianchi, Federal University of São Paulo

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

285

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Women that attended to clinical visit to insertion of IUD

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Evaluation of pain previous and 5 minutes after outpatient insertion of IUD / IUS using the Visual Analog Scale of Pain
Andre navne:
  • VAS
Evaluation of Blood pressure ( mmHg), previous and 5 minutes after outpatient insertion of IUD / IUS by sphygmomanometer.
Andre navne:
  • BP evaluation
Evaluation of radial pulse (beats per minute) previous and 5 minutes after outpatient insertion of IUD / IUS by pulse oximetry
Andre navne:
  • Pulse evaluation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of pain after insertion of IUD/IUS
Tidsramme: 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
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of blood pressure modification after insertion of IUD/IUS
Tidsramme: 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
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
Tidsramme: 1 day
Correlate the pain score of VAS with clinical factors as age, parity, BMI, hysterometry, previous vaginal delivery
1 day
Evaluation of radial pulse modification after insertion of IUD/IUS
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: Zsuzsanna IK Jarmy di Bella, Federal University of São Paulo

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2015

Primær færdiggørelse (Faktiske)

1. maj 2015

Studieafslutning (Faktiske)

1. maj 2015

Datoer for studieregistrering

Først indsendt

25. maj 2015

Først indsendt, der opfyldte QC-kriterier

1. juni 2015

Først opslået (Skøn)

3. juni 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. juni 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2015

Sidst verificeret

1. juni 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Nº CEP: 0272/2015

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner