Acute Myocardial InfarctionPhase 1NCT00792181
To Relieve Pain and Anxiety - an Intervention Study in Ambulance Services
A Phase 1 study testing Midazolam and Course intervention - a professional development course for caregivers. in people with Acute Myocardial Infarction and Pain, run by Sahlgrenska University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myocardial Infarction, Pain
- What is being tested?
- Midazolam and Course intervention - a professional development course for caregivers.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,800 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Nov 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Who may be able to join
- Patients in Ambulance service with chest pain and suspicion about acute coronary syndrome.
- At least 4 on a Coloured Analogue Scale.
Who cannot join
- 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
About this study
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.
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.
Read more
Following questions are formulated:
- 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?
- Conditions
- Acute Myocardial Infarction, Pain
- Being tested
- Midazolam, Course intervention - a professional development course for caregivers.
- 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.
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Midazolam 1 mg: 70 years or more and less than 70 kg Midazolam 2 mg: under 70 years and 70 kg or more
Course intervention - a professional development course for caregivers.Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Medical intervention - with benzodiazepines (Midazolam). Receives: Drug: Midazolam |
| 2 | Experimental | Course intervention - a professional development course for caregivers. Receives: Other: Course intervention - a professional development course for caregivers. |
| 3 | Experimental | Combination of both medical interventions and a professional development course for caregivers. Receives: Drug: Midazolam; Other: Course intervention - a professional development course for caregivers. |
| 4 | No intervention | No intervention at all = a control group |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00792181
- Sponsor's protocol ID
- MPA Dnr 151:2008/4564
- Status last verified
- Nov 2008
- First submitted
- 14 Nov 2008
- Last updated
- 17 Nov 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30486789Wireklint 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.
PubMed 27594805
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00792181
- Acronym / sponsor ID
- MPA Dnr 151:2008/4564
- Conditions
- 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.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Nov 2008 (actual)
- First posted
- 17 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MidazolamMedical intervention - with benzodiazepines (Midazolam). |
| 2 | Experimental | Other: Course intervention - a professional development course for caregivers.Course intervention - a professional development course for caregivers. |
| 3 | Experimental | Drug: Midazolam, Other: Course intervention - a professional development course for caregivers.Combination of both medical interventions and a professional development course for caregivers. |
| 4 | No intervention | –No intervention at all = a control group |
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients in Ambulance service with chest pain and suspicion about acute coronary syndrome.
- At least 4 on a Coloured Analogue Scale.
Key exclusion criteria (8 listed)
- Blood pressure less than 100 mmHg
- Children under 18 years
- Under the influence of alcohol
- Under the influence of drugs
- Treatment with benzodiazepines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamMidazolam 1 mg: 70 years or more and less than 70 kg Midazolam 2 mg: under 70 years and 70 kg or more | Drug | 1, 3 |
| 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. | Other | 2, 3 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2008.
- Derived from this study: PubMed 30486789Holmberg 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.
- Derived from this study: PubMed 27594805Wireklint 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Midazolam and Course intervention - a professional development course for caregivers. in people with Acute Myocardial Infarction and Pain, run by Sahlgrenska University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00792181, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2008.