Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Junta de Andalucia | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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).
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposition to multimedia content | Experimental | Ad hoc design multimedia content in a tablet (video with sound and subtitles). |
|
| Standard procedures | No Intervention | Standard procedures. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exposition to multimedia content | Other | Video and images watched on a tablet. Patient could decide which information want to watch. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety state | Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18. | Minute 0. |
| Anxiety state change | Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18. | Minute 10. |
| Experience measure of the ambulance service | Tool Ambulance Patient Reported Experience Measure (APREMS) | 1 measure: one week after the patient has been discharge from hospital. Qualitative interview tool. |
| Comfort | "Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10. | Minute 0. |
| Comfort change | "Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10. | Minute 10. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessment | Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10. | Minute 0. |
| Pain assessment change | Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergio Cazorla, PhDc | Contact | +34647862311 | sergio.cazorla@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Olga Paloma, PhD | Universidad Cádiz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Cádiz | Cadiz | 11001 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D001008 | Anxiety Disorders |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
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).
Not provided
Not provided
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.
| Minute 10. |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |