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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04560023
Other study ID # ITI-PI-0019-N-17
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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.
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