Clinical Trials Directory

Trials / Completed

CompletedNCT07051304

Video-Based Versus Numerical Pain Assessment in Postoperative Patients: A Pilot Study

Evaluation of Patient Preference and Interpretability of Video-Based Pain Expression Scenarios Compared to the Numerical Rating Scale (NRS) in the Postoperative Period: A Prospective Single-Center Pilot Study

Status
Completed
Phase
Study type
Observational
Enrollment
240 (actual)
Sponsor
Kanuni Sultan Suleyman Training and Research Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The goal of this observational pilot study is to evaluate whether video-based visual scenarios representing different levels of pain are preferred over the traditional Numerical Rating Scale (NRS) by postoperative patients. The study also investigates the clarity and interpretability of both methods and examines the level of agreement between the selected video and the reported NRS score.

Detailed description

This prospective, observational, single-center pilot study evaluates the usability and preference of a novel video-based pain expression method compared to the standard Numerical Rating Scale (NRS) in postoperative adult patients. Videos representing 5 different pain intensities (NRS 1-2, 3-4, 5-6, 7-8, 9-10) were created using AI-assisted scenario generation and VEO-3 video production tools. Each video features age- and sex-matched models (male and female in three age categories: 18-44, 45-65, \>65 years) demonstrating realistic, simulated pain expressions. In the recovery unit, patients aged 18 and above will be shown the video series and asked to: Select the video that best reflects their current pain Report their pain using the NRS Indicate which method (video or NRS) they prefer for expressing pain Indicate which method they found easier to understand Collected data will include demographic variables, surgical details, comorbidities, and responses to the pain assessment tools. The study will enroll at least 82 participants based on power analysis. Data will be anonymized and analyzed using descriptive and inferential statistics including Chi-square, Spearman correlation, and p\<0.05 significance level. The planned sample size was amended prior to the enrollment of the first patient, increasing from 120 to 240 participants. This adjustment was made to ensure sufficient statistical power for planned subgroup analyses.

Conditions

Interventions

TypeNameDescription
OTHERnumerical rating scaleThe Numerical Rating Scale (NRS) is a standardized, self-reported pain assessment tool in which patients are asked to rate their pain intensity on a scale from 0 to 10. 0 represents "no pain" 10 represents "the worst pain imaginable"
OTHERVideo-Based Pain Expression ScenariosThis novel pain assessment method involves showing postoperative patients a set of pre-recorded video scenarios that visually represent different levels of pain intensity. The videos are 8 seconds long and were created using AI-generated scripts and VEO-3 software. Each scenario corresponds to a specific Numerical Rating Scale (NRS) range (1-2, 3-4, 5-6, 7-8, 9-10) and is portrayed by actors matched to the patient's age group and gender (18-44, 45-65, \>65 years; male and female versions available). Participants are asked to watch the full video set and select the one that best represents their current postoperative pain experience. This intervention is designed to offer a visual and contextual method of pain expression, particularly beneficial for patients who have difficulty understanding or using abstract numerical scales.

Timeline

Start date
2025-10-15
Primary completion
2025-12-15
Completion
2026-01-04
First posted
2025-07-04
Last updated
2026-01-13

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07051304. Inclusion in this directory is not an endorsement.