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

NCT ID: NCT04560023

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-06-01

Brief Summary

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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

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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).

Conditions

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Myocardial Infarction, Acute Anxiety State Emergencies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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Exposition to multimedia content

Ad hoc design multimedia content in a tablet (video with sound and subtitles).

Group Type EXPERIMENTAL

Exposition to multimedia content

Intervention Type OTHER

Video and images watched on a tablet. Patient could decide which information want to watch.

Standard procedures

Standard procedures.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exposition to multimedia content

Video and images watched on a tablet. Patient could decide which information want to watch.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Junta de Andalucia

OTHER_GOV

Sponsor Role collaborator

University of Cadiz

OTHER

Sponsor Role lead

Responsible Party

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Sergio Cazorla Calderon

Co-Investigator; PhDc

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olga Paloma, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Cádiz

Locations

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Universidad de Cádiz

Cadiz, , Spain

Site Status

Countries

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Spain

Central Contacts

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Sergio Cazorla, PhDc

Role: CONTACT

+34647862311

Facility Contacts

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Sergio Cazorla, PhDc

Role: primary

+34647862311

Olga Paloma, PhD

Role: backup

+34956019102

Other Identifiers

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ITI-PI-0019-N-17

Identifier Type: -

Identifier Source: org_study_id

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