NCT07051304

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2025

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

October 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 4, 2026

Completed
Last Updated

January 13, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

June 25, 2025

Last Update Submit

January 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patient Preference Between Video-Based and Numerical Rating Scale (NRS) Pain Assessment Methods

    This outcome evaluates which pain assessment method patients prefer after being exposed to both the video-based pain expression scenarios and the traditional NRS scale. Patients will be asked, "Which method did you prefer to express your pain?" and their answers (Video or NRS) will be recorded. The result will be reported as the proportion of participants preferring each method.

    Immediately after postoperative evaluation in the recovery unit (within 1 hour after surgery)

Secondary Outcomes (3)

  • Concordance Between Selected Video and Reported NRS Score

    Immediately after postoperative evaluation

  • Perceived Clarity of Pain Assessment Methods

    Immediately after postoperative evaluation

  • Influence of Demographics on Method Preference

    Immediately after postoperative evaluation

Interventions

The 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"

This 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.

Eligibility Criteria

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

The study population consists of adult postoperative patients (aged 18 years and older) who are recovering in the recovery room following any type of surgery. Participants must be conscious, cooperative, and capable of evaluating and expressing their pain using both video-based scenarios and the Numerical Rating Scale (NRS). All participants will provide written informed consent prior to participation. The population will include a range of age and gender groups to allow evaluation of method preference across demographic subgroups.

You may qualify if:

  • Age ≥ 18 years
  • Undergoing any type of surgery
  • Admitted to the postoperative recovery unit (PACU) in stable condition
  • Able to understand and respond to questions
  • Provide written informed consent (ICF)

You may not qualify if:

  • Age \< 18 years
  • Refusal or inability to provide informed consent
  • Visual impairment or blindness
  • Impaired consciousness or cognitive inability to complete the questionnaire
  • History of psychiatric illness
  • Planned postoperative ICU admission
  • Patients undergoing surgery for intracranial mass
  • History of seizure 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, Istanbul, 34303, Turkey (Türkiye)

Location

Study Officials

  • Engin ihsan Turan, Specialist

    Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 25, 2025

First Posted

July 4, 2025

Study Start

October 15, 2025

Primary Completion

December 15, 2025

Study Completion

January 4, 2026

Last Updated

January 13, 2026

Record last verified: 2026-01

Locations