Study of a Prototype Software to Help Surgical Patients Manage Their Pain Medication

Not Applicable

Completed

• Conditions: Post-operative Situation

• Registration Number: NCT05707247
• Lead Sponsor: University Hospital, Strasbourg, France

Brief Summary

The experimental medical device is a prototype software. The device comes in the form of a smartphone with a touch interface. The smartphone used to support the software is a commercial smartphone marked CE. The study aims at assessing the feasibility of the use of this expert, patient- decision support systems.

The study hypothesis is that the clinical use of the experimental device is feasible.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-27
• Study First Posted: 2023-01-31
• Study Start: 2023-02-13
• Primary Completion: 2023-06-28
• Study Completion: 2023-07-04
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-10
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the feasibility of the INSAMED computer tool	Day 2 post operative	agreement between INSAMED computer tool and the recommendations established by caregivers. The data from INSAMED computer tool will be collected by extracting the history of the digital interface (commercial smartphone) hosting the expert system.

Secondary Outcome Measures

Name	Time	Method
assess the security of the device	Day 2 post operative	Safety analysis of INSAMED software through evaluation of serious adverse events based on a expert panel reviewing.
Assess patient satisfaction with usual care	60 minutes after software activation.	Patient satisfaction with the routine care therapeutic response measured by an analog visual scale between 0 and 100, measured 60 minutes after software activation.
Assess patient satisfaction with the ease of use of the experimental device	60 minutes after software activation.	Patient satisfaction with the ease of use of the INSAMED device measured by an analog visual scale between 0 and 100, measured 60 minutes after software activation
Evaluate the time delay, in usual care setting, of rescue drug administrations after surgery, to confirm the interest of developing expert systems to improve the existing one.	60 minutes after software activation	Delay, in minutes, between soliciting a ward nurse as usual practice (e.g., doorbell) and the administration of the therapeutic response.; This time will be collected by the Research IDE during patient interview. 60 minutes after software activation. The patient will simultaneously request the standard care IDE (doorbell) and the INSAMED tool.

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France