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

Primary Purpose

Myocardial Infarction, Acute, Anxiety State, Emergencies

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Exposition to multimedia content
Sponsored by
University of Cadiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Myocardial Infarction, Acute focused on measuring ambulances, video

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Universidad de Cádiz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exposition to multimedia content

Standard procedures

Arm Description

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

Standard procedures.

Outcomes

Primary Outcome Measures

Anxiety state
Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.
Anxiety state change
Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.
Experience measure of the ambulance service
Tool Ambulance Patient Reported Experience Measure (APREMS)
Comfort
"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.
Comfort change
"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.

Secondary Outcome Measures

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

Full Information

First Posted
October 20, 2019
Last Updated
July 27, 2023
Sponsor
University of Cadiz
Collaborators
Junta de Andalucía
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1. Study Identification

Unique Protocol Identification Number
NCT04560023
Brief Title
Effectiveness of Multimedia Exposure in Patients Transferred to Hospital Suffering From Acute Myocardial Infarction
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cadiz
Collaborators
Junta de Andalucía

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Acute, Anxiety State, Emergencies
Keywords
ambulances, video

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
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.
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exposition to multimedia content
Arm Type
Experimental
Arm Description
Ad hoc design multimedia content in a tablet (video with sound and subtitles).
Arm Title
Standard procedures
Arm Type
No Intervention
Arm Description
Standard procedures.
Intervention Type
Other
Intervention Name(s)
Exposition to multimedia content
Intervention Description
Video and images watched on a tablet. Patient could decide which information want to watch.
Primary Outcome Measure Information:
Title
Anxiety state
Description
Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.
Time Frame
Minute 0.
Title
Anxiety state change
Description
Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.
Time Frame
Minute 10.
Title
Experience measure of the ambulance service
Description
Tool Ambulance Patient Reported Experience Measure (APREMS)
Time Frame
1 measure: one week after the patient has been discharge from hospital. Qualitative interview tool.
Title
Comfort
Description
"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.
Time Frame
Minute 0.
Title
Comfort change
Description
"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.
Time Frame
Minute 10.
Secondary Outcome Measure Information:
Title
Pain assessment
Description
Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10.
Time Frame
Minute 0.
Title
Pain assessment change
Description
Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10.
Time Frame
Minute 10.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio Cazorla, PhDc
Phone
+34647862311
Email
sergio.cazorla@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olga Paloma, PhD
Organizational Affiliation
Universidad Cádiz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de Cádiz
City
Cadiz
ZIP/Postal Code
11001
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergio Cazorla, PhDc
Phone
+34647862311
Email
sergio.cazorla@gmail.com
First Name & Middle Initial & Last Name & Degree
Olga Paloma, PhD
Phone
+34956019102
Email
olga.paloma@uca.es
First Name & Middle Initial & Last Name & Degree
Jose Manuel Romero Sanchez, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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