Myocardial Infarction, AcuteNCT04560023
Effectiveness of Multimedia Exposure in Patients Transferred to Hospital Suffering From Acute Myocardial Infarction
A study testing Exposition to multimedia content in people with Myocardial Infarction, Acute and Anxiety State, run by University of Cadiz at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Myocardial Infarction, Acute, Anxiety State, Emergencies
- What is being tested?
- Exposition to multimedia content
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2023to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Sedation and/or assisted ventilation.
- Blinded or visual defects.
- Deafness.
- Severe mental disorders or behavior disorders.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universidad de Cádiz
Cadiz, 11001
Sergio Cazorla, PhDc, +34647862311, sergio.cazorla@gmail.com
Olga Paloma, PhD, +34956019102, olga.paloma@uca.es
About this study
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.
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).
Read the 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).
- Conditions
- Myocardial Infarction, Acute, Anxiety State, Emergencies
- Being tested
- Exposition to multimedia content
- Keywords
- ambulances, video
- Medical subject headings
- Myocardial Infarction, Anxiety Disorders, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposition to multimedia contentOther
Video and images watched on a tablet. Patient could decide which information want to watch.
| Study group | Role | What they receive |
|---|---|---|
| Exposition to multimedia content | Experimental | Ad hoc design multimedia content in a tablet (video with sound and subtitles). Receives: Other: Exposition to multimedia content |
| Standard procedures | No intervention | Standard procedures. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety state
Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.
Measured: Minute 0.
Anxiety state change
Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.
Measured: Minute 10.
Experience measure of the ambulance service
Tool Ambulance Patient Reported Experience Measure (APREMS)
Measured: 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.
Measured: Minute 0.
Comfort change
"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.
Measured: Minute 10.
Secondary outcomes (2)
Pain assessment
Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10.
Measured: Minute 0.
Pain assessment change
Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10.
Measured: Minute 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Nov 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cadiz
- Sponsor type
- University, hospital or other
- Collaborators
- Junta de Andalucia
- Responsible party
- Principal investigator, Sergio Cazorla Calderon, University of Cadiz
- Investigators
- Olga Paloma, PhD, Principal investigator, Universidad Cádiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04560023
- Sponsor's protocol ID
- ITI-PI-0019-N-17
- Status last verified
- Jul 2023
- First submitted
- 20 Oct 2019
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04560023
- Acronym / sponsor ID
- ITI-PI-0019-N-17
- Conditions
- Myocardial Infarction, Acute, Anxiety State, Emergencies
- Keywords
- ambulances, video
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- University of CadizUniversity, hospital or other
- Collaborators
- Junta de Andalucia
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Exposition to multimedia content | Experimental | Other: Exposition to multimedia contentAd hoc design multimedia content in a tablet (video with sound and subtitles). |
| Standard procedures | No intervention | –Standard procedures. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- Sedation and/or assisted ventilation.
- Blinded or visual defects.
- Deafness.
- Severe mental disorders or behavior disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposition to multimedia contentVideo and images watched on a tablet. Patient could decide which information want to watch. | Other | Exposition to multimedia content |
Primary outcome
Anxiety state
Time frame: Minute 0.
Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.
Anxiety state change
Time frame: Minute 10.
Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.
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)
Comfort
Time frame: Minute 0.
"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.
Comfort change
Time frame: Minute 10.
"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.
2 secondary outcomes
Pain assessment
Time frame: Minute 0.
Pain assessment change
Time frame: Minute 10.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Paloma, PhD principal investigator
Universidad Cádiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposition to multimedia content in people with Myocardial Infarction, Acute and Anxiety State, run by University of Cadiz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sergio Cazorla, PhDc (+34647862311, sergio.cazorla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety state (time frame: Minute 0.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.