Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT07051304
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Video-Based Versus Numerical Pain Assessment in Postoperative Patients: A Pilot Study
Sponsor:
Kanuni Sultan Suleyman Training and Research Hospital
Organization:
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: