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To Relieve Pain and Anxiety - an Intervention Study in Ambulance Services
This study has been completed.
Sponsored by: Sahlgrenska University Hospital, Sweden
Information provided by: Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT00792181
  Purpose

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 Intervention Phase
Acute Myocardial Infarction
Pain
Drug: Midazolam
Other: Course intervention - a professional development course for caregivers.
Phase I

MedlinePlus related topics: Anxiety Cardiomyopathy Caregivers Heart Attack
Drug Information available for: Midazolam Midazolam hydrochloride Midazolam maleate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment
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.

Further study details as provided by Sahlgrenska University Hospital, Sweden:

Estimated Enrollment: 2800
Study Start Date: June 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
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
2: Experimental
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.
3: Experimental
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.
4: No Intervention
No intervention at all = a control group

  Eligibility

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Medical Products Agency - Sweden ( Med. doctor )
Study ID Numbers: MPA Dnr 151:2008/4564
Study First Received: November 14, 2008
Last Updated: November 14, 2008
ClinicalTrials.gov Identifier: NCT00792181  
Health Authority: Sweden: Medical Products Agency

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.

Study placed in the following topic categories:
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Pain
Ischemia
Midazolam
Infarction
Cardiomyopathies
Myocardial Infarction

Additional relevant MeSH terms:
Anesthetics, Intravenous
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Central Nervous System Depressants
Pharmacologic Actions
Adjuvants, Anesthesia
Pathologic Processes
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Cardiovascular Diseases
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009