Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Sahlgrenska University Hospital, Sweden |
---|---|
Information provided by: | Sahlgrenska University Hospital, Sweden |
ClinicalTrials.gov Identifier: | NCT00792181 |
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?
Condition | Intervention | Phase |
---|---|---|
Acute Myocardial Infarction Pain |
Drug: Midazolam Other: Course intervention - a professional development course for caregivers. |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment |
Official Title: | Intervention Study to Relieve Pain and Anxiety in Acute Myocardial Disease Focusing on Treatment With Benzodiazepines(Midazolam)and the Importance of a Caring Relation. |
Estimated Enrollment: | 2800 |
Study Start Date: | June 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Medical intervention - with benzodiazepines (Midazolam).
|
Drug: Midazolam
Midazolam 1 mg: 70 years or more and less than 70 kg Midazolam 2 mg: under 70 years and 70 kg or more
|
2: Experimental
Course intervention - a professional development course for caregivers.
|
Other: 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.
|
3: Experimental
Combination of both medical interventions and a professional development course for caregivers.
|
Drug: Midazolam
Midazolam 1 mg: 70 years or more and less than 70 kg Midazolam 2 mg: under 70 years and 70 kg or more
Other: 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.
|
4: No Intervention
No intervention at all = a control group
|
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Medical Products Agency - Sweden ( Med. doctor ) |
Study ID Numbers: | MPA Dnr 151:2008/4564 |
Study First Received: | November 14, 2008 |
Last Updated: | November 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00792181 |
Health Authority: | Sweden: Medical Products Agency |
The focus is the pain reduce in the first 15 minutes for patients suffering an acute myocardial infarction, treated by caregivers in Ambulance service. |
Necrosis Heart Diseases Myocardial Ischemia Vascular Diseases Pain |
Ischemia Midazolam Infarction Cardiomyopathies Myocardial Infarction |
Anesthetics, Intravenous Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action GABA Modulators Physiological Effects of Drugs Psychotropic Drugs Anesthetics Central Nervous System Depressants Pharmacologic Actions |
Adjuvants, Anesthesia Pathologic Processes Anesthetics, General Therapeutic Uses Hypnotics and Sedatives GABA Agents Cardiovascular Diseases Anti-Anxiety Agents Central Nervous System Agents |