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

Tracking Information
First Received Date ^ICMJE	November 14, 2008
Last Updated Date	November 14, 2008
Start Date ^ICMJE	June 2008
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	To Relieve Pain and Anxiety - an Intervention Study in Ambulance Services
Official Title ^ICMJE	Intervention Study to Relieve Pain and Anxiety in Acute Myocardial Disease Focusing on Treatment With Benzodiazepines(Midazolam)and the Importance of a Caring Relation.
Brief 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?
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Acute Myocardial Infarction Pain
Intervention ^ICMJE	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.
Study Arm (s)	Experimental: 1 Medical intervention - with benzodiazepines (Midazolam). Intervention: Drug: Midazolam Experimental: 2 Course intervention - a professional development course for caregivers. Intervention: Other: Course intervention - a professional development course for caregivers. Experimental: 3 Combination of both medical interventions and a professional development course for caregivers. Interventions: Drug: Midazolam Other: Course intervention - a professional development course for caregivers. No Intervention: 4 No intervention at all = a control group
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	2800
Completion Date	Not Provided
Primary Completion Date	November 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients in Ambulance service with chest pain and suspicion about acute coronary syndrome. At least 4 on a Coloured Analogue Scale. Exclusion Criteria: Blood pressure less than 100 mmHg Children under 18 years Under the influence of alcohol Under the influence of drugs Treatment with benzodiazepines Disorientated Communication problems Trauma
Gender	Not Provided
Ages	Not Provided
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00792181
Other Study ID Numbers ^ICMJE	MPA Dnr 151:2008/4564
Has Data Monitoring Committee	Yes
Responsible Party	Med. doctor, Medical Products Agency - Sweden
Study Sponsor ^ICMJE	Sahlgrenska University Hospital, Sweden
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sahlgrenska University Hospital, Sweden
Verification Date	November 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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