Comparison of Methods for Recording Post Operative Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Given novel electronic pain recording device, Given Hand-written pain journal, Smartphone app.
- Who it may be relevant to
- Registry conditions: Pain, Postoperative. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Methods for Recording Post Operative Pain: A Prospective Randomized Trial
Overview
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
- Device Given 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. - Other Given 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. - Other Smartphone 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.
Primary outcome measures
- Comparing Methods for Pain Score collection [Time frame: On patient discharge, up to 2 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Zuckerberg San Francisco General Hospital — San Francisco
Identifiers
NCT: NCT06206148 · 23-40666