Comparison of Methods for Recording Post Operative Pain

Not Applicable

Not yet recruiting

• Conditions: Pain, Postoperative
• Interventions: Other: Given Hand-written pain journal; Device: Given novel electronic pain recording device; Other: Smartphone app

• Registration Number: NCT06206148
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-04
• Study First Posted: 2024-01-16
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-14
• Study Start: 2024-03
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 147

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hand-written pain journal	Given Hand-written pain journal	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.
Novel electronic pain recording device	Given novel electronic pain recording device	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.
Smartphone app	Smartphone app	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.

Primary Outcome Measures

Name	Time	Method
Comparing Methods for Pain Score collection	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.

Trial Locations

Locations (1)

Zuckerberg San Francisco General Hospital; 🇺🇸 San Francisco, California, United States