Effectiveness of Multimedia Exposure in Patients Transferred to Hospital Suffering From Acute Myocardial Infarction

July 27, 2023 updated by: Sergio Cazorla Calderon, University of Cadiz

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.

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Cadiz, Spain, 11001
        • Universidad de Cádiz
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jose Manuel Romero Sanchez, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exposition to multimedia content
Ad hoc design multimedia content in a tablet (video with sound and subtitles).
Other: Exposition to multimedia content
Video and images watched on a tablet. Patient could decide which information want to watch.
No Intervention: Standard procedures
Standard procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety state
Time Frame: Minute 0.
Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.
Minute 0.
Anxiety state change
Time Frame: Minute 10.
Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.
Minute 10.
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)
1 measure: one week after the patient has been discharge from hospital. Qualitative interview tool.
Comfort
Time Frame: Minute 0.
"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.
Minute 0.
Comfort change
Time Frame: Minute 10.
"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.
Minute 10.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: Minute 0.
Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10.
Minute 0.
Pain assessment change
Time Frame: Minute 10.
Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10.
Minute 10.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cadiz

Collaborators

Junta de Andalucía

Investigators

  • Principal Investigator: Olga Paloma, PhD, Universidad Cádiz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

October 20, 2019

First Submitted That Met QC Criteria

September 16, 2020

First Posted (Actual)

September 23, 2020

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITI-PI-0019-N-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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