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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Med. doctor, Medical Products Agency - Sweden
ClinicalTrials.gov Identifier: NCT00792181     History of Changes
Other Study ID Numbers: MPA Dnr 151:2008/4564
Study First Received: November 14, 2008
Last Updated: November 14, 2008
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.

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

ClinicalTrials.gov processed this record on July 13, 2014