Validation of the Thai Version CPOT and BPS in Postoperative ICU Patients

May 22, 2017 updated by: Karuna Wongtangman, Mahidol University

Validation of the Thai Version Critical Care Pain Observation Tool and Behavioral Pain Scale in Postoperative Mechanically Ventilated ICU Patients

The prospective study set forth to test Thai version CPOT and BPS for validity, reliability, and practicality. After translation, both pain scales were tested for concurrent validity, discriminant validity, criterion validity, and inter-rater reliability in patients who were intubated during the postoperative period. Opinions regarding practicality were elicited via questionnaires from nurses who had been using and were familiar with these two pain scales.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The prospective study set forth to test Thai version CPOT and BPS for validity, reliability, and practicality. After translation, both pain scales were tested for concurrent validity, discriminant validity, criterion validity, and inter-rater reliability in patients who were intubated during the postoperative period. Opinions regarding practicality were elicited via questionnaires from nurses who had been using and were familiar with these two pain scales.

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkok Noi, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Postoperative Mechanically Ventilated Adult ICU Patients

Description

Inclusion Criteria:

  • aged ≥18 years
  • be able to communicate in Thai
  • intubated during postoperative period.

Exclusion Criteria:

  • quadriplegia
  • patients with limb or facial injuries
  • patients receiving neuromuscular blockers
  • patients with limb mobility adversely affected by stroke
  • patients with epidural catheter used for postoperative pain control

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
construct validity
Time Frame: before and after analgesic given during 24 hours postoperative period
before and after analgesic given during 24 hours postoperative period

Secondary Outcome Measures

Outcome Measure
Time Frame
content validity, concurrent validity, inter-rater reliability, and practicality
Time Frame: 24 hours after operation
24 hours after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2015

Primary Completion (ACTUAL)

July 15, 2016

Study Completion (ACTUAL)

September 15, 2016

Study Registration Dates

First Submitted

May 22, 2017

First Submitted That Met QC Criteria

May 22, 2017

First Posted (ACTUAL)

May 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 23, 2017

Last Update Submitted That Met QC Criteria

May 22, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Si553/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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