NCT06206148

Comparison of Methods for Recording Post Operative Pain

Comparison of Methods for Recording Post Operative Pain: A Prospective Randomized Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 147 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of the current study is to identify the optimal method of collection of pain intensity data. The study will compare three collection methods: a hand-written pain journal, a smartphone app, and a novel electronic pain recorder device. Patients will be randomly assigned to one of three methods and instructed to record their pain level as often as they like. The number of pain intensity recordings per day will then be compared across groups.

Detailed description

Pain is a universal experience and at the forefront of all things medicine; however, the way medical professionals deal with it lacks coherence. Clinicians often ask their patients how their pain is, but seldom document it with enough information to be useful. The purpose of this study is to determine how we can collect the most self-reported pain intensity data. The investigators will collect this data with time and date-stamped Visual Analogue Scale-a pain rating scale from 0-10-scores for each patient in the study, randomized to one of three groups (pen \& paper, app, and pain recorder device). As pain is a universal experience and a hallmark sign of many disease states, having a detailed recording of the patient's pain journey is of utmost importance, and understanding that pain with further granularity can only help with the diagnosis of worsening disease, personalization of treatment, and outcomes assessment.

Conditions

• Pain, Postoperative

Interventions

Type	Name	Description
DEVICE	Given novel electronic pain recording device	Patients in this arm will be given a custom-built pain recording device to see if the method of self-reported data collection has any effect on how many data points are collected.
OTHER	Given Hand-written pain journal	Patients in this arm will be given a hand-written pain journal to see if the method of self-reported data collection has any effect on how many data points are collected.
OTHER	Smartphone app	Patients in this arm will be given a research smartphone with survey app to see if the method of self-reported data collection has any effect on how many data points are collected.

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-01-16
• Last updated: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study