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

This study has been completed.
Sponsor:
Information provided by:
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT00792181
First received: November 14, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted

November 14, 2008
November 14, 2008
June 2008
November 2008   (final data collection date for primary outcome measure)
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No Changes Posted
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To Relieve Pain and Anxiety - an Intervention Study in Ambulance Services
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.

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?

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Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Myocardial Infarction
  • Pain
  • 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.
  • Experimental: 1
    Medical intervention - with benzodiazepines (Midazolam).
    Intervention: Drug: Midazolam
  • Experimental: 2
    Course intervention - a professional development course for caregivers.
    Intervention: Other: Course intervention - a professional development course for caregivers.
  • Experimental: 3
    Combination of both medical interventions and a professional development course for caregivers.
    Interventions:
    • Drug: Midazolam
    • Other: Course intervention - a professional development course for caregivers.
  • No Intervention: 4
    No intervention at all = a control group
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2800
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November 2008   (final data collection date for primary outcome measure)

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
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Contact information is only displayed when the study is recruiting subjects
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NCT00792181
MPA Dnr 151:2008/4564
Yes
Med. doctor, Medical Products Agency - Sweden
Sahlgrenska University Hospital, Sweden
Not Provided
Not Provided
Sahlgrenska University Hospital, Sweden
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP