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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
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)

Inclusion Criteria:

  1. Patients in Ambulance service with chest pain and suspicion about acute coronary syndrome.
  2. At least 4 on a Coloured Analogue Scale.

Exclusion Criteria:

  1. Blood pressure less than 100 mmHg
  2. Children under 18 years
  3. Under the influence of alcohol
  4. Under the influence of drugs
  5. Treatment with benzodiazepines
  6. Disorientated
  7. Communication problems
  8. 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

    First Posted
    November 14, 2008
    Last Updated
    November 14, 2008
    Sponsor
    Sahlgrenska University Hospital, Sweden
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    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

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

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