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

Emergencies Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04560023
• Other study ID #: ITI-PI-0019-N-17
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: July 2023
• Source: University of Cadiz
• Contact: Sergio Cazorla, PhDc
• Phone: +34647862311
• Email: sergio.cazorla[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: June 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety State
• Emergencies
• Infarction
• Myocardial Infarction
• Myocardial Infarction, Acute

Intervention

Other:
• Exposition to multimedia content
Video and images watched on a tablet. Patient could decide which information want to watch.

Locations

Country	Name	City	State
Spain	Universidad de Cádiz	Cadiz

Sponsors (2)

Lead Sponsor	Collaborator
University of Cadiz	Junta de Andalucía

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety state	Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.	Minute 0.
Primary	Anxiety state change	Tool State-Trait Anxiety Scale (STAI-E6). Less punctuation means better outcomes. Range 0-18.	Minute 10.
Primary	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.
Primary	Comfort	"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.	Minute 0.
Primary	Comfort change	"Kolcaba General Comfort Questionnaire scale". More punctuation means better outcomes. Range 0-10.	Minute 10.
Secondary	Pain assessment	Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10.	Minute 0.
Secondary	Pain assessment change	Analogic Pain Scale. Less punctuation means better outcomes. Range 0-10.	Minute 10.