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

NCT ID: NCT00792181

Last Updated: 2008-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

2800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Brief Summary

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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 BorĂ¥s. 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?

Detailed Description

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Conditions

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Acute Myocardial Infarction Pain

Keywords

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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 Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Medical intervention - with benzodiazepines (Midazolam).

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Midazolam 1 mg: 70 years or more and less than 70 kg Midazolam 2 mg: under 70 years and 70 kg or more

2

Course intervention - a professional development course for caregivers.

Group Type EXPERIMENTAL

Course intervention - a professional development course for caregivers.

Intervention Type OTHER

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

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

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Midazolam 1 mg: 70 years or more and less than 70 kg Midazolam 2 mg: under 70 years and 70 kg or more

Course intervention - a professional development course for caregivers.

Intervention Type OTHER

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 at all = a control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Midazolam

Midazolam 1 mg: 70 years or more and less than 70 kg Midazolam 2 mg: under 70 years and 70 kg or more

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Medical Products Agency - Sweden

References

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Holmberg M, Andersson H, Winge K, Lundberg C, Karlsson T, Herlitz J, Wireklint Sundstrom B. Association between the reported intensity of an acute symptom at first prehospital assessment and the subsequent outcome: a study on patients with acute chest pain and presumed acute coronary syndrome. BMC Cardiovasc Disord. 2018 Nov 28;18(1):216. doi: 10.1186/s12872-018-0957-3.

Reference Type DERIVED
PMID: 30486789 (View on PubMed)

Wireklint Sundstrom B, Holmberg M, Herlitz J, Karlsson T, Andersson H. Possible effects of a course in cardiovascular nursing on prehospital care of patients experiencing suspected acute coronary syndrome: a cluster randomised controlled trial. BMC Nurs. 2016 Sep 2;15(1):52. doi: 10.1186/s12912-016-0175-1. eCollection 2016.

Reference Type DERIVED
PMID: 27594805 (View on PubMed)

Other Identifiers

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MPA Dnr 151:2008/4564

Identifier Type: -

Identifier Source: org_study_id