NCT03164525

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 1, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

10 months

First QC Date

May 22, 2017

Last Update Submit

May 22, 2017

Conditions

Adult ICU Patients

Keywords

Thai versionvalidatedCritical Care Pain Observation ToolBehavioral Pain Scaleadult ICU patients

Outcome Measures

Primary Outcomes (1)

  • construct validity

    before and after analgesic given during 24 hours postoperative period

Secondary Outcomes (1)

  • content validity, concurrent validity, inter-rater reliability, and practicality

    24 hours after operation

Interventions

Critical care pain observation tool (CPOT)DIAGNOSTIC_TEST

test validity and reliability of Thai-version CPOT and BPS

Also known as: Behavioral pain scale (BPS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Postoperative Mechanically Ventilated Adult ICU Patients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

Location

Study Design

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

Study Record Dates

First Submitted

May 22, 2017

First Posted

May 23, 2017

Study Start

October 1, 2015

Primary Completion

July 15, 2016

Study Completion

September 15, 2016

Last Updated

May 23, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)