NCT04555928

Brief Summary

Pain intensity is commonly measured in research and clinical settings.1 Different pain intensity domains can be assessed, depending on the specific goals of the researcher or clinician. These include current pain, and recalled average pain, least pain and worst pain in the past 24 hours or 7 days. Although average pain (in the past 24 hours or 7 days) is arguably the most common pain intensity domain assessed by researchers and clinicians, some researches indicate that in chronic pain samples, worst pain is more strongly associated with disability than average pain.2 Thus, while current pain is likely the most appropriate pain intensity domain in acute pain contexts (e.g., during medical procedures), both average and worst pain are important domains to consider assessing the chronic pain context. As such, research to understand the most reliable and valid measures for assessing these domains in different pain populations is critical for both researchers and clinicians.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

October 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

October 6, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

August 28, 2020

Last Update Submit

October 2, 2020

Conditions

Keywords

pain measurement, geriatric patients

Outcome Measures

Primary Outcomes (5)

  • Psychometric properties (validity, reliability, and utility) of Verbal Numerical Rating Scale (VNRS) 0-10

    Verbal Numerical Rating Scale or VNRS consists of 0-10 when 0 represents no pain and 10 represents worst pain imaginable. Patients are asked to rate his/her pain verbally.

    September 2020 until August 2021

  • Psychometric properties (validity, reliability, and utility) of Visual Analog Scale (VAS) 0-10

    Visual Analog Scale or VAS is a 10-cm line where the end of the left side represents no pain and the end of the right side represents worst pain imaginable. The VAS line has no number at all. Patients are asked to draw a mark on the line where it represents their pain.

    September 2020 until August 2021

  • Psychometric properties (validity, reliability, and utility) of Numerical Rating Scale (NRS) 0-10

    Numerical Rating Scale or NRS is a 10-cm line with numbers 0-10 on it. Zero is on the end of the left side representing no pain while 10 is on the end of the right side representing worst pain imaginable. Each centimeter of the line has a number. Patients are asked to mark on the line.

    September 2020 until August 2021

  • Psychometric properties (validity, reliability, and utility) of Faces Pain Scale (FPS) 6 faces

    Faces Pain Scale or FPS consists of 6 faces. Pain severity increases from the left to the right. Patients are asked to mark on the face representing their pain.

    September 2020 until August 2021

  • Psychometric properties (validity, reliability, and utility) of Verbal Rating Scale (VRS) 6 words

    Verbal Rating Scale or VRS consists of 6 descriptors from left to right: no pain, very mild pain, mild pain, moderate pain, severe pain, very severe pain.

    September 2020 until August 2021

Interventions

This is a prospective cohort (survey) study. It has no intervention.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This quantitative-descriptive cross sectional study will be performed in Songklanagarind Hospital, Thailand, recruiting patients with pain from different inpatient wards and outpatient clinics, including the (1) pain clinic, (2) orthopedic clinic, (3) orthopedic wards, (4) rehabilitation clinic, (5) radiotherapy clinic, (6) oncology clinic, (7) internal medicine wards, (8) surgical wards, (9) trauma ward, (10) gynecological ward and (11) private wards.

You may qualify if:

  • Age ≥ 65 years old.
  • Endorsing having at least some pain in the past week, from any diagnosis.
  • Can speak and write in Thai, as determined by an ability to answer details about demographic information
  • No motor deficits in the hands that would interfere with their ability to respond to a paper-and-pencil questionnaire

You may not qualify if:

  • Lack of fluency in Thai
  • Neurological disorder or psychiatric illness that would interfere with participation or ability to provide informed consent
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117-126. doi: 10.1016/0304-3959(86)90228-9.

    PMID: 3785962BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Anesthesiology

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 21, 2020

Study Start

October 15, 2020

Primary Completion

February 1, 2021

Study Completion

August 1, 2021

Last Updated

October 6, 2020

Record last verified: 2020-10