A Functional Pain Scale to Improve the Patient Experience

NCT04124289 | Completed

• 1 other identifier: 1906-25
• Study Type: observational
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This will be an observational cohort study to evaluate pain measurement after surgery using a new functional pain scale.

Conditions

Pain Measurement

Outcome Measures

Primary Outcomes (4)

• Change in pain score using functional pain scale questionnaire

  Change in pain measurement using new functional pain scale from baseline postoperatively until discharge. The functional pain scale is a scale of 10 descriptive words related to pain and ability to function, ranging from minimal to immobilizing

  Through study completion, an average of 4 days.

• Change in pain score using FACES pain scale

  Change in pain measurement using FACES pain scale from baseline postoperatively until discharge. The scale includes pictures of facial expressions with correlating numerical scale of 0-10, 0 being no hurt and 10 being the worst hurt.

  Through study completion, an average of 4 days.

• Change in pain score using numeric 0-10 rating scale

  Change in pain measurement using standard numeric rating scale from baseline postoperatively until discharge. The numeric rating scale is 0-10 where 0 is no pain, 5 is moderate pain and 10 is the worst pain.

  Through study completion, an average of 4 days.

• Change in functionality

  Change in patient's ability to complete daily functions from baseline postoperatively until discharge. Physical therapy and occupational therapy reports will be reviewed to see if pain appears to interfere with the ability to participate in rehabilitation therapy.

  Through study completion, an average of 4 days.

Secondary Outcomes (3)

• Patient preference for ease of use of the three pain scales (functional, FACES or numerical)

  Through study completion, an average of 4 days.

• Provider preference for ease of use of the three pain scales (functional, FACES or numerical)

  Through study completion, an average of 4 days.

• Opioid administration

  Through study completion, an average of 4 days

Study Arms (1)

Pain post surgery

Patients who have completed surgery will be assessed with three types of pain scales. A new pain scale, a functional pain scale (FPS), will be compared to two pain scales that are routinely used: the FACES pain scale and the numeric rating scale (NRS).

Other: Pain measurement using 3 scales

Interventions

Pain measurement using 3 scales OTHER

Patients will assess their pain after surgery using three different pain scales.

Pain post surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted for orthopedic surgery procedures who will be assessed for pain

You may qualify if:

• Completed orthopedic (hip or knee) surgery
• English as primary language and able to read
• Low risk as assessed by Opioid Risk Assessment Tool (ORAT)
• No history of opioid abuse
• Patients with a diagnosis of chronic pain other than the scheduled hip or knee meeting the above criteria may be included.

You may not qualify if:

• Previous diagnosis of cognitive impairment

Sponsors & Collaborators

• The Guthrie Clinic: lead

Study Sites (1)

Robert Packer Hospital

Sayre, Pennsylvania, 18840, United States

Location

Study Officials

• Harris W Thomas, BSN, RN-BC

  The Guthrie Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2019
• First Posted: October 11, 2019
• Study Start: October 29, 2019
• Primary Completion: January 21, 2020
• Study Completion: July 2, 2020
• Last Updated: January 13, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)