Comparison of Methods for Recording Post Operative Pain

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06206148
• Other study ID #: 23-40666
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: June 2024

Study information

• Verified date: February 2024
• Source: University of California, San Francisco
• Contact: Meir T Marmor, MD
• Phone: 6504776238
• Email: meir.marmor[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 147
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Zuckerberg San Francisco General Hospital	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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