Comparison of Methods for Recording Post Operative Pain

University of California San Francisco (UCSF)

Status: Enrolling

Conditions: Pain, Postoperative

Treatments: Device: Given novel electronic pain recording device; Other: Smartphone app; Other: Given Hand-written pain journal

Study type: Interventional

Funder types: Other

Identifiers

NCT06206148

23-40666

Details and patient eligibility

About

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.

Full 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.

Enrollment: 147 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 3 patient groups

Hand-written pain journal

Experimental group

Description:

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.

Treatment:

Other: Given Hand-written pain journal

Smartphone app

Experimental group

Description:

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.

Treatment:

Other: Smartphone app

Novel electronic pain recording device

Experimental group

Description:

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.

Treatment:

Device: Given novel electronic pain recording device