Pain, PostoperativeNCT06206148
Comparison of Methods for Recording Post Operative Pain
A study testing Given novel electronic pain recording device, Given Hand-written pain journal and Smartphone app in people with Pain, Postoperative, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Given novel electronic pain recording device, Given Hand-written pain journal and Smartphone app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient over 18 years old
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
Meir T Marmor, MD, 650-477-6238, meir.marmor@ucsf.edu
Daniel Rohde, BS, 4088966607, daniel.rohde@ucsf.edu
About this study
Official title: Comparison of Methods for Recording Post Operative Pain: A Prospective Randomized Trial
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Given novel electronic pain recording device, Given Hand-written pain journal, Smartphone app
- Keywords
- Pain Recorder, Device, Self-report
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Given novel electronic pain recording deviceDevice
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.
Given Hand-written pain journalOther
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 appOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Given novel electronic pain recording device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On patient discharge, up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Mar 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meir T Marmor, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206148
- Sponsor's protocol ID
- 23-40666
- Status last verified
- Jul 2025
- First submitted
- 4 Jan 2024
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Not sharing IPD
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methods for Recording Post Operative Pain: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT06206148
- Acronym / sponsor ID
- 23-40666
- Conditions
- Pain, Postoperative
- Keywords
- Pain Recorder, Device, Self-report
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 147 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hand-written pain journal | Experimental | Other: Given Hand-written pain journalPost-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. |
| Smartphone app | Experimental | Other: Smartphone appPost-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. |
| Novel electronic pain recording device | Experimental | Device: Given novel electronic pain recording devicePost-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient over 18 years old
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Given novel electronic pain recording devicePatients 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. | Device | Novel electronic pain recording device |
| Given Hand-written pain journalPatients 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 | Hand-written pain journal |
| Smartphone appPatients 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. | Other | Smartphone app |
Primary outcome
Comparing Methods for Pain Score collection
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No. Not sharing IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meir T Marmor, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Given novel electronic pain recording device, Given Hand-written pain journal and Smartphone app in people with Pain, Postoperative, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Meir T Marmor, MD (6504776238, meir.marmor@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing Methods for Pain Score collection (time frame: On patient discharge, up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.