A Functional Pain Scale to Improve the Patient Experience

Sponsor

The Guthrie Clinic (Other)

Overall Status

Unknown status

CT.gov ID

NCT04124289

Collaborator

(none)

Enrollment

Location

23.1

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain Measurement	Other: Pain measurement using 3 scales

Detailed Description

Patients admitted for orthopedic surgery may take part in this research. Participants will be assessed using three different pain scales: numeric rating scale (NRS), FACES pain scale and a new functional pain scale (FPS).

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Pilot Study to Validate a Functional Pain Scale in Order to Improve the Patient Experience

Actual Study Start Date :

Oct 29, 2019

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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 Patients will assess their pain after surgery using three different pain scales.

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Change in pain score using functional pain scale questionnaire [Through study completion, an average of 4 days.]
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
Change in pain score using FACES pain scale [Through study completion, an average of 4 days.]
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.
Change in pain score using numeric 0-10 rating scale [Through study completion, an average of 4 days.]
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.
Change in functionality [Through study completion, an average of 4 days.]
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.

Secondary Outcome Measures

Patient preference for ease of use of the three pain scales (functional, FACES or numerical) [Through study completion, an average of 4 days.]
Questionnaire: Patient will be asked to answer one question to choose which of the three pain scales they prefer for reporting their level of pain. On a scale of 1 to 3 with 1 being the best for reporting pain, the patient will choose which pain scale they would rank a 1.
Provider preference for ease of use of the three pain scales (functional, FACES or numerical) [Through study completion, an average of 4 days.]
Questionnaire: Provider will be asked to answer one question regarding which of the three pain scales they found easiest to complete. On a scale of 1 to 3 with 1 being the best for ease of use, the provider will choose which pain scale they would rank a 1.
Opioid administration [Through study completion, an average of 4 days]
Dose of opioid administered postoperatively during the hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

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.

Exclusion Criteria:

Previous diagnosis of cognitive impairment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Robert Packer Hospital	Sayre	Pennsylvania	United States	18840

Sponsors and Collaborators

The Guthrie Clinic

Investigators

Principal Investigator: Harris W Thomas, BSN, RN-BC, The Guthrie Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Guthrie Clinic

ClinicalTrials.gov Identifier:

NCT04124289

Other Study ID Numbers:

1906-25

First Posted:

Oct 11, 2019

Last Update Posted:

Dec 10, 2019

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 10, 2019