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

Sponsor

University of Cadiz (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04560023

Collaborator

Junta de Andalucía (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Myocardial Infarction, Acute Anxiety State Emergencies	Other: Exposition to multimedia content	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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).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

Official Title:

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.

Anticipated Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Anxiety state [Minute 0.]
Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.
Anxiety state change [Minute 10.]
Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.
Experience measure of the ambulance service [1 measure: one week after the patient has been discharge from hospital. Qualitative interview tool.]
Tool Ambulance Patient Reported Experience Measure (APREMS)
Comfort [Minute 0.]
"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.
Comfort change [Minute 10.]
"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.

Secondary Outcome Measures

Pain assessment [Minute 0.]
Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10.
Pain assessment change [Minute 10.]
Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad de Cádiz	Cadiz		Spain	11001

Sponsors and Collaborators

University of Cadiz
Junta de Andalucía

Investigators

Principal Investigator: Olga Paloma, PhD, Universidad Cádiz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sergio Cazorla Calderon, Co-Investigator; PhDc, University of Cadiz

ClinicalTrials.gov Identifier:

NCT04560023

Other Study ID Numbers:

ITI-PI-0019-N-17

First Posted:

Sep 23, 2020

Last Update Posted:

Apr 28, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sergio Cazorla Calderon, Co-Investigator; PhDc, University of Cadiz

ambulances

video

Additional relevant MeSH terms:

Myocardial Infarction

Infarction

Emergencies

Study Results

No Results Posted as of Apr 28, 2021