- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00792181
To Relieve Pain and Anxiety - an Intervention Study in Ambulance Services
Intervention Study to Relieve Pain and Anxiety in Acute Myocardial Disease Focusing on Treatment With Benzodiazepines(Midazolam)and the Importance of a Caring Relation.
This is an intervention study focusing on both medical and nursing questions. The study is a joint project between the Ambulance services at four cities in West Sweden and Knowledge and research centre, PreHospen at University of Borås. The aim is to prove the importance of a caring relation between a patient and a caregiver in cases when a caregiver treats a patient with benzodiazepines (Midazolam). The overall aim is to show that knowledge and skills in both caring science and medicine can be applied at the same time in order to relieve pain and anxiety in acute myocardial disease.
The nursing intervention involves a professional development course for caregivers. The course is expected to deepen the caregivers' knowledge about the encounter with patients as well as cardiovascular treatment.
Following questions are formulated:
A. What are the effects regarding relieving pain and anxiety in acute myocardial disease? B. What are the effects regarding circulatory influence? C. What are the effects regarding patients' experiences of the ambulance services? D. What are the effects regarding number of care days in relation to acute myocardial disease? E. What are the effects of patients' disease complications?
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Fase 1
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Patients in Ambulance service with chest pain and suspicion about acute coronary syndrome.
- At least 4 on a Coloured Analogue Scale.
Exclusion Criteria:
- Blood pressure less than 100 mmHg
- Children under 18 years
- Under the influence of alcohol
- Under the influence of drugs
- Treatment with benzodiazepines
- Disorientated
- Communication problems
- Trauma
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 1
Medical intervention - with benzodiazepines (Midazolam).
|
Midazolam 1 mg: 70 years or more and less than 70 kg Midazolam 2 mg: under 70 years and 70 kg or more
|
|
Eksperimentell: 2
Course intervention - a professional development course for caregivers.
|
The nursing intervention involves a professional development course for caregivers.
The course is expected to deepen the caregivers' knowledge about the encounter with patients as well as cardiovascular treatment.
|
|
Eksperimentell: 3
Combination of both medical interventions and a professional development course for caregivers.
|
Midazolam 1 mg: 70 years or more and less than 70 kg Midazolam 2 mg: under 70 years and 70 kg or more
The nursing intervention involves a professional development course for caregivers.
The course is expected to deepen the caregivers' knowledge about the encounter with patients as well as cardiovascular treatment.
|
|
Ingen inngripen: 4
No intervention at all = a control group
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Holmberg M, Andersson H, Winge K, Lundberg C, Karlsson T, Herlitz J, Wireklint Sundstrom B. Association between the reported intensity of an acute symptom at first prehospital assessment and the subsequent outcome: a study on patients with acute chest pain and presumed acute coronary syndrome. BMC Cardiovasc Disord. 2018 Nov 28;18(1):216. doi: 10.1186/s12872-018-0957-3.
- Wireklint Sundstrom B, Holmberg M, Herlitz J, Karlsson T, Andersson H. Possible effects of a course in cardiovascular nursing on prehospital care of patients experiencing suspected acute coronary syndrome: a cluster randomised controlled trial. BMC Nurs. 2016 Sep 2;15(1):52. doi: 10.1186/s12912-016-0175-1. eCollection 2016.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Iskemi
- Patologiske prosesser
- Nekrose
- Myokardiskemi
- Hjertesykdommer
- Kardiovaskulære sykdommer
- Vaskulære sykdommer
- Hjerteinfarkt
- Infarkt
- Fysiologiske effekter av legemidler
- Nevrotransmittere agenter
- Molekylære mekanismer for farmakologisk virkning
- Sentralnervesystemdepressiva
- Anestesimidler, intravenøst
- Anestesimidler, general
- Bedøvelsesmidler
- Beroligende midler
- Psykotropiske stoffer
- Hypnotika og beroligende midler
- Adjuvanser, anestesi
- Anti-angst midler
- GABA modulatorer
- GABA-agenter
- Midazolam
Andre studie-ID-numre
- MPA Dnr 151:2008/4564
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