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Clinical Trials/NCT04560023
NCT04560023
Not Yet Recruiting
N/A

Effectiveness of Multimedia Content Exposure in Improving the Experience and Reported Patient Outcomes in Patients Suffering From Acute Mycardial Infarction During the Transfer to Hospital: a Clinical Trial.

University of Cadiz1 site in 1 country96 target enrollmentNovember 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Myocardial Infarction, Acute
Sponsor
University of Cadiz
Enrollment
96
Locations
1
Primary Endpoint
Anxiety state
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 1, 2023
End Date
June 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sergio Cazorla Calderon

Co-Investigator; PhDc

University of Cadiz

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Anxiety state

Time Frame: Minute 0.

Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.

Anxiety state change

Time Frame: Minute 10.

Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.

Experience measure of the ambulance service

Time Frame: 1 measure: one week after the patient has been discharge from hospital. Qualitative interview tool.

Tool Ambulance Patient Reported Experience Measure (APREMS)

Comfort

Time Frame: Minute 0.

"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.

Comfort change

Time Frame: Minute 10.

"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.

Secondary Outcomes

  • Pain assessment change(Minute 10.)
  • Pain assessment(Minute 0.)

Study Sites (1)

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