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

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ClinicalTrials.gov Identifier: NCT00792181
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : November 17, 2008
Sponsor:
Information provided by:

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?


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Pain Drug: Midazolam Other: Course intervention - a professional development course for caregivers. Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2008
Primary Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Caregivers
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
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
Experimental: 2
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.
Experimental: 3
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.
No Intervention: 4
No intervention at all = a control group


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Criteria

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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Med. doctor, Medical Products Agency - Sweden
ClinicalTrials.gov Identifier: NCT00792181     History of Changes
Other Study ID Numbers: MPA Dnr 151:2008/4564
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: November 17, 2008
Last Verified: November 2008

Keywords provided by Sahlgrenska University Hospital, Sweden:
The focus is the pain reduce in the first 15 minutes for patients suffering an acute myocardial infarction, treated by caregivers in Ambulance service.

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Midazolam
Acetaminophen
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antipyretics