Completed

NCT Number: NCT05707247

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

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.

Completed

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Key information

Conditions

Post-operative Situation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or Female 18 years or older (no upper age limit)
Operated within a surgical department of of the Hautepierre University Hospitals of Strasbourg
Patient understanding and reading French
Subject neurosensorially able of interacting with a tactile electronical interface
Subject able to understand research objectives, risks and provide dated and signed informed consent
Subject covered by a health insurance scheme

Exclusion criteria

Patient with neuropsychiatric or sensory disorders that may interfere with their use of the visual interface
Unable to provide informed information (subject in emergency, difficulty understanding the subject, etc.)
Pregnant or lactating woman (on declaration)
Patient under safeguard of justice, under guardianship, under curatorship

Treatment and study plan

software

Device

The experimental medical device is a prototype software. It is a patient interface.

The device comes in the form of a smartphone with a touch screen

Primary outcomes

Rate of Agreement Between the Recommendations of the INSAMED Computer Tool and the Recommendations Made by a Healthcare Professional From the Research Team Based on the Best Practice Algorithm.

Time frame: Day 2 post operative

Recommendation pairs were analyzed in this Outcome Measure for the number of recommendation pairs that matched recommendations between the INSAMED Computer Tool and the Healthcare Professional,

The recommendations of the INSAMED computer tool will be collected by extracting the history from the digital interface (commercial smartphone) hosting the expert system.

The recommendations established by a caregiver from the research team based on a best practice algorithm will be determined: After receiving the device activation message, a caregiver (registered nurse) from the research team will establish a recommendation based on the medical algorithm for treating the symptom, medical prescriptions and the patient's interview without consulting INSAMED. The response provided by the nurse in charge of the patient is not used as the gold standard because, in practice, the responses provided may differ from the medical ideal (e.g. unavailability of staff or non-compliance with the care plan).

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Evaluation of the Feasibility of an Expert Decision Support System for Patients Regarding the Optimization of the Management of Drugs With Conditional Administration in the Surgical Department: Pilot Study

Acronym: MORPHEE 2

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jan 31, 2023
Registry last updated: Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.