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Comparison of Methods for Recording Post Operative Pain

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06206148
Enrollment
147
Registered
2024-01-16
Start date
2024-03-01
Completion date
2026-06-30
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

Pain Recorder, Device, Self-report

Brief 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.

Interventions

DEVICEGiven 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.

OTHERGiven 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.

OTHERSmartphone 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.

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

The three different methods are very apparent and masking wouldn't provide any benefit

Intervention model description

Post-operative orthopedic surgery patients will be randomly assigned to one of three pain collection methods and instructed to record their pain level as often as they like. The three methods of pain collection are: a hand-written pain journal, a smartphone app, and a novel electronic pain recorder device.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Comparing Methods for Pain Score collectionOn patient discharge, up to 2 weeksPain 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.

Countries

United States

Contacts

Primary ContactMeir T Marmor, MD
meir.marmor@ucsf.edu6504776238

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026