To Relieve Pain and Anxiety - an Intervention Study in Ambulance Services

Study Overview
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Brief Summary
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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?

Official Title
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Intervention Study to Relieve Pain and Anxiety in Acute Myocardial Disease Focusing on Treatment With Benzodiazepines(Midazolam)and the Importance of a Caring Relation.

Conditions
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Pain, Acute Myocardial Infarction

Intervention / Treatment
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* Drug: Midazolam
* Other: Course intervention - a professional development course for caregivers.


Participation Criteria
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Eligibility Criteria
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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

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Medical intervention - with benzodiazepines (Midazolam). | Drug: Midazolam<br>* Midazolam 1 mg: 70 years or more and less than 70 kg Midazolam 2 mg: under 70 years and 70 kg or more<br>|
| Experimental: 2<br>Course intervention - a professional development course for caregivers. | Other: Course intervention - a professional development course for caregivers.<br>* 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.<br>|
| Experimental: 3<br>Combination of both medical interventions and a professional development course for caregivers. | Drug: Midazolam<br>* Midazolam 1 mg: 70 years or more and less than 70 kg Midazolam 2 mg: under 70 years and 70 kg or more<br>Other: Course intervention - a professional development course for caregivers.<br>* 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.<br>|
| No Intervention: 4<br>No intervention at all = a control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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The focus is the pain reduce in the first 15 minutes for patients suffering an acute myocardial infarction, treated by caregivers in Ambulance service.