Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Anxiety State
  • Emergencies
  • Myocardial Infarction, Acute
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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).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.Primary Purpose: Screening

Participation Requirements

Age
Between 18 years and 100 years
Gender
Both males and females

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. ...

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).

Tracking Information

NCT #
NCT04560023
Collaborators
Junta de Andalucía
Investigators
Principal Investigator: Olga Paloma, PhD Universidad Cádiz