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

Sahlgrenska University Hospital

Status and phase: Completed; Phase 1

Conditions: Acute Myocardial Infarction; Pain

Treatments: Drug: Midazolam; Other: Course intervention - a professional development course for caregivers.

Study type: Interventional

Funder types: Other

Identifiers

NCT00792181

MPA Dnr 151:2008/4564

Details and patient eligibility

About

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?

Enrollment: 2,800 estimated patients

Sex

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,800 participants in 4 patient groups

1

Experimental group

Description:

Medical intervention - with benzodiazepines (Midazolam).

Treatment:

Drug: Midazolam

2

Experimental group

Description:

Course intervention - a professional development course for caregivers.

Treatment:

Other: Course intervention - a professional development course for caregivers.

3

Experimental group

Description:

Combination of both medical interventions and a professional development course for caregivers.

Treatment:

Drug: Midazolam

Other: Course intervention - a professional development course for caregivers.

4

No Intervention group

Description:

No intervention at all = a control group