Comparison of Methods for Recording Post Operative Pain

NCT06206148 | Recruiting FDA Device

• 1 other identifier: 23-40666
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

Pain Recorder; Device; Self-report

Outcome Measures

Primary Outcomes (1)

• Comparing Methods for Pain Score collection

  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.

  On patient discharge, up to 2 weeks

Study Arms (3)

Hand-written pain journal

EXPERIMENTAL

Post-operative orthopedic surgery patient will be given a pen and journal with chart inside and instructed to fill out the chart with time/date and pain intensity level as frequently as they want.

Other: Given Hand-written pain journal

Smartphone app

EXPERIMENTAL

Post-operative orthopedic surgery patient will be given a research smartphone and an app to record their pain and will be instructed to fill out the pain survey as frequently as they want.

Other: Smartphone app

Novel electronic pain recording device

EXPERIMENTAL

Post-operative orthopedic surgery patient will be given a pain recording device and will be instructed to input their pain using the buttons on the device as frequently as they want.

Device: Given novel electronic pain recording device

Interventions

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.

Novel electronic pain recording device

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.

Hand-written pain journal

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.

Smartphone app

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient over 18 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94110, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Meir T Marmor, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meir T Marmor, MD

CONTACT

6504776238; meir.marmor@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The three different methods are very apparent and masking wouldn't provide any benefit
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)