NCT06456853

Brief Summary

This prospective study will be conducted in surgical wards, assessing postoperative patients. Initially, patients will be evaluated using the VAS method. Subsequently, they will be shown five AI-generated images depicting different pain levels and will select the image that best represents their pain. A follow-up survey will assess the effectiveness of each method. Using ChatGPT-4/DALL-E, images corresponding to VAS scores of 1-2, 3-4, 5-6, 7-8, and 9-10 will be created. Patients will choose the image that best describes their pain, aiming to determine if AI-supported visuals offer a more accurate alternative to VAS for pain assessment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

June 14, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

June 8, 2024

Last Update Submit

February 19, 2025

Conditions

Keywords

Postoperative PainArtificial IntelligencePain assesment

Outcome Measures

Primary Outcomes (1)

  • Pain assesment

    The primary outcome for this research is to compare the effectiveness of AI-generated pain assessment visuals with the traditional Visual Analog Scale (VAS) in accurately evaluating and expressing patients' pain levels. This will be measured through patient-reported ease of use, clarity, and usefulness of both methods, as well as patient preference for either method in pain assessment.

    10 minutes

Study Arms (2)

Visual Analog Scale Score

The Visual Analog Scale (VAS) pain score is a simple and effective method used to measure patients' pain levels. This method is typically represented by a line ranging from 0 to 10, where 0 indicates no pain and 10 indicates the most severe pain. Patients are asked to mark a point on the line that corresponds to their level of pain.

Other: Pain assesment

Images maded by Artificial Intelligence

Pain assesment maded by images which is created from ChatGPT/DALLE

Other: Pain assesment

Interventions

We will ask patients about their pain and will try to asses their pain scores. Then we will ask them to which methot is more suitable for assesment.

Images maded by Artificial IntelligenceVisual Analog Scale Score

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

VAS scoring and pain assessment using visuals will be conducted on at least 398 patients aged 18 and above who have undergone any surgery, at any time within the first 24 hours postoperatively.

You may qualify if:

  • years old and above
  • Underwent surgery for any reason
  • Consented to participate in the study and signed the informed consent form

You may not qualify if:

  • Patients under 18 years old
  • Patients who did not sign the informed consent form
  • Patients with visual impairments
  • Patients whose level of consciousness is not sufficient to complete the survey
  • Patients with a history of psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, 34303, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
anesthesiology and reanimation specialist

Study Record Dates

First Submitted

June 8, 2024

First Posted

June 13, 2024

Study Start

June 14, 2024

Primary Completion

February 1, 2025

Study Completion

February 2, 2025

Last Updated

February 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

All patients IPD will delete and we will give randomised patient number to them

Locations