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NCT00792181 Clinical Trial

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

Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00792181
Other study ID # MPA Dnr 151:2008/4564
Secondary ID
Status Completed
Phase Phase 1
First received November 14, 2008
Last updated November 14, 2008
Start date June 2008

Study information
Verified date November 2008
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial 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?

Recruitment information / eligibility
Status Completed
Enrollment 2800
Est. completion date
Est. primary completion date November 2008
Accepts healthy volunteers
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden
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