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NCT Number: NCT06206148

Comparison of Methods for Recording Post Operative Pain

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient over 18 years old

Exclusion criteria

  • Patient cannot use a smartphone
  • Patient cannot use his hands to write or press a button
  • Patient has a nerve catheter (has no pain)
  • Altered mental status
  • Neuropathy causing loss of pain sensation

Treatment and study plan

Given novel electronic pain recording device

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.

Given Hand-written pain journal

Other

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.

Smartphone app

Other

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.

Primary outcomes

  1. Comparing Methods for Pain Score collection

    Time frame: On patient discharge, up to 2 weeks

    Pain Scores will be measured on the Visual Analog Scale (VAS) via 3 different methods to determine the best way to collect pain intensity data. The Visual Analog Scale goes from 0-10 where 0 means no pain and 10 means maximum pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Meir T Marmor, MD

CONTACT

[email protected]

6504776238

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2024
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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