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

NCT04560023 | Unknown DMC

• 1 other identifier: ITI-PI-0019-N-17
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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).

Conditions

Myocardial Infarction, Acute; Anxiety State; Emergencies

Keywords

ambulances; video

Outcome Measures

Primary Outcomes (5)

• Anxiety state

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

  Minute 0.

• Anxiety state change

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

  Minute 10.

• Experience measure of the ambulance service

  Tool Ambulance Patient Reported Experience Measure (APREMS)

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

• Comfort

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

  Minute 0.

• Comfort change

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

  Minute 10.

Secondary Outcomes (2)

• Pain assessment

  Minute 0.

• Pain assessment change

  Minute 10.

Study Arms (2)

Exposition to multimedia content

EXPERIMENTAL

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

Other: Exposition to multimedia content

Standard procedures

NO INTERVENTION

Standard procedures.

Interventions

Exposition to multimedia content OTHER

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

Exposition to multimedia content

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Sedation and/or assisted ventilation.
• Blinded or visual defects.
• Deafness.
• Severe mental disorders or behavior disorders.

Sponsors & Collaborators

• University of Cadiz: lead
• Junta de Andalucia: collaborator

Study Sites (1)

Universidad de Cádiz

Cadiz, 11001, Spain

Location

MeSH Terms

Conditions

Myocardial Infarction; Anxiety Disorders; Emergencies

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Mental Disorders; Disease Attributes

Study Officials

• Olga Paloma, PhD

  Universidad Cádiz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Cazorla, PhDc

CONTACT

+34647862311; sergio.cazorla@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator; PhDc

Model Details: 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).

Study Record Dates

• First Submitted: October 20, 2019
• First Posted: September 23, 2020
• Study Start: November 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)