Anxiety State, Emergencies, Myocardial Infarction, Acute
Conditions
Keywords
ambulances, video
Brief summary
Randomised clinical trial, single-center, blinded assessment, controlled with standard practice with two-group parallel design. Eligible patients are those assisted and transferred suffering from ST-Elevation myocardial infarction in an Advanced Life Support ambulance from an public Emergency Medical Service in the Cadiz area (Spain). Experimental group will watch an ad hoc design multimedia content in a tablet (video with sound and subtitles) during the transfer and control group will be assisted as standard procedures. Main outcome variables will be conformed by patient reported outcomes (anxiety State, pain and comfort) and patient experience (transfer experience).
Detailed description
Due to intrinsic characteristics of ambulance transport raises stress or anxiety in patients. Moreover, other outcomes such as pain and some specific vital signs are affected. In the last years, empowerment patient strategies have been launched in several clinical settings but none in the ER field. Main objective Comparative assessment of the effectiveness of multimedia exposure vs standard clinical procedures to improve the experience and patient reported outcomes in patients suffering from ST-Elevation myocardial infarction transferred to hospital in an Advanced Life Support ambulance for a percutaneous coronary intervention (PCI). Methods Randomised clinical trial, single-center, blinded assessment, controlled with usual practice with two-group parallel design. Eligible patients are those assisted and transferred suffering from STEMI in an Advance Life Support (ALS) ambulance from public Emergency Medical System in the Cadiz region. Experimental group will watch multimedia content on a tablet (movie or image with sound) ad hoc designed, control group will be assisted as usual procedures. Main outcomes will be conformed by informed patient results (anxiety State, pain and comfort) and patient experience (transfer experience).
Interventions
OTHERExposition to multimedia content
Video and images watched on a tablet. Patient could decide which information want to watch.
Sponsors
Junta de Andalucia
University of Cadiz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Masking description
Randomization variable encoding will be blinded for researchers, only known by an external collaborator designed by the main researcher. Statistical analysis will be performed by researchers who will be blinded for the assignation to experimental and control groups.
Intervention model description
Randomisation in blocks will be considered. Software will contain and allocation sequence, in each block, 50% of patients will be allocated in control group (standard practice) and the other 50% will be allocated in the experimental group (multimedia exposure).
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* All genders patients. * Assisted by ALS ambulance. * Diagnosed with STEMI, Killip I. * Transferred by an ambulance to the hospital to receive a percutaneous coronary intervention. * Informed consent must be signed. * Conscious and oriented patients.
Exclusion criteria
* Sedation and/or assisted ventilation. * Blinded or visual defects. * Deafness. * Severe mental disorders or behavior disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort change | Minute 10. | Kolcaba General Comfort Questionnaire scale. More punctuation means better outcomes. Range 0-10. |
| Anxiety state change | Minute 10. | Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18. |
| Experience measure of the ambulance service | 1 measure: one week after the patient has been discharge from hospital. Qualitative interview tool. | Tool Ambulance Patient Reported Experience Measure (APREMS) |
| Comfort | Minute 0. | Kolcaba General Comfort Questionnaire scale. More punctuation means better outcomes. Range 0-10. |
| Anxiety state | Minute 0. | Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain assessment change | Minute 10. | Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10. |
| Pain assessment | Minute 0. | Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10. |
Countries
Spain
Contacts
Primary ContactSergio Cazorla, PhDc
Outcome results
None listed