To Relieve Pain and Anxiety - an Intervention Study in Ambulance Services
Primary Purpose
Acute Myocardial Infarction, Pain
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Midazolam
Course intervention - a professional development course for caregivers.
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring The focus is the pain reduce in the first 15 minutes for patients suffering an acute myocardial infarction, treated by caregivers in Ambulance service.
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
1
2
3
4
Arm Description
Medical intervention - with benzodiazepines (Midazolam).
Course intervention - a professional development course for caregivers.
Combination of both medical interventions and a professional development course for caregivers.
No intervention at all = a control group
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00792181
First Posted
November 14, 2008
Last Updated
November 14, 2008
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT00792181
Brief Title
To Relieve Pain and Anxiety - an Intervention Study in Ambulance Services
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Pain
Keywords
The focus is the pain reduce in the first 15 minutes for patients suffering an acute myocardial infarction, treated by caregivers in Ambulance service.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Medical intervention - with benzodiazepines (Midazolam).
Arm Title
2
Arm Type
Experimental
Arm Description
Course intervention - a professional development course for caregivers.
Arm Title
3
Arm Type
Experimental
Arm Description
Combination of both medical interventions and a professional development course for caregivers.
Arm Title
4
Arm Type
No Intervention
Arm Description
No intervention at all = a control group
Intervention Type
Drug
Intervention Name(s)
Midazolam
Intervention Description
Midazolam 1 mg: 70 years or more and less than 70 kg Midazolam 2 mg: under 70 years and 70 kg or more
Intervention Type
Other
Intervention Name(s)
Course intervention - a professional development course for caregivers.
Intervention Description
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.
10. Eligibility
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
30486789
Citation
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.
Results Reference
derived
PubMed Identifier
27594805
Citation
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.
Results Reference
derived
Learn more about this trial
To Relieve Pain and Anxiety - an Intervention Study in Ambulance Services
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