Comparison of AI-Generated Pain Scoring Visuals With Visual Analog Scale (VAS) for Pain Assessment

February 19, 2025 updated by: Engin Ihsan Turan, Kanuni Sultan Suleyman Training and Research Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study Objective The primary objective of this study is to compare and evaluate the effectiveness of AI-generated pain visuals in assisting patients to express their pain levels with the Visual Analog Scale (VAS). By allowing patients to more accurately depict their pain through AI-supported visuals, the study aims to enhance pain management practices in clinical settings.

Study Significance Pain management is a critical component of healthcare, directly impacting patient well-being and treatment success. The VAS is a widely used tool for subjective pain assessment but can be challenging for some patients due to its abstract nature. AI-generated visuals offer a potentially more precise and understandable way for patients to communicate their pain, potentially leading to more accurate and personalized pain assessments and management.

This study aims to measure the contribution of AI-generated pain visuals to more accurate pain assessment and to explore the potential applications of this technology. Additionally, the study seeks to understand the advantages and limitations of this approach compared to traditional methods like VAS, thereby enhancing the role of AI in pain management practices.

Expected Benefits and Risks

Expected Benefits:

Improved Pain Expression: AI-generated visuals may help patients articulate their pain more clearly, leading to better pain management in clinical settings.

Personalized Treatment Approaches: Enhanced pain expression can provide healthcare providers with opportunities to create more personalized treatment plans, especially beneficial for chronic pain patients.

Enhanced Clinical Decision-Making: The use of AI visuals may facilitate more objective and reproducible pain assessments, improving overall pain management strategies.

Potential Risks:

Misinterpretation Risk: AI-generated visuals might misinterpret patient pain in certain cases, especially if the visuals are misleading or complex.

Dependence on Technology: Over-reliance on AI tools may overlook the importance of human judgment and the subjective nature of pain assessment.

Study Design This prospective study will be conducted in surgical wards, assessing postoperative patients. Initially, patients will be evaluated using the conventional VAS method, which involves marking their pain on a 0-10 scale. Subsequently, patients will be shown five AI-generated images depicting different pain levels and asked to select the image that best represents their pain. A follow-up survey will assess which method the patients found more effective for expressing their pain.

VAS Scoring:

Patients will mark their pain level on a line ranging from 0 (no pain) to 10 (worst pain).

AI-Generated Visuals:

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. These images will specifically depict facial expressions reflecting the respective pain levels. Patients will choose the image that best describes their pain.

This study aims to identify whether AI-supported visuals provide a more accurate and user-friendly alternative to traditional VAS scoring for pain assessment.

VAS Score Descriptions VAS Score 1-2: A middle-aged man showing signs of mild discomfort.

VAS Score 3-4: A young female athlete on a soccer field expressing moderate pain.

VAS Score 5-6: A man in a kitchen environment displaying severe pain from a cut.

VAS Score 7-8: A young male feeling severe shoulder pain.

VAS Score 9-10: A young woman experiencing intense pain.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34303
        • Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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 Intelligence
Pain assesment maded by images which is created from ChatGPT/DALLE
Other: Pain assesment
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain assesment
Time Frame: 10 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AI Images

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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