Validation of the Thai Version CPOT and BPS in Postoperat... | NCT03164525

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

NCT03164525

Sponsor

Mahidol University

Status

Completed

Last Update Posted

May 23, 2017Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Adult ICU Patients

Interventions

Critical care pain observation tool (CPOT)

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2015Actual

Primary Completion Date

Jul 15, 2016Actual

Completion Date

Sep 15, 2016Actual

First Submitted Date

May 22, 2017

First Submission Date that Met QC Criteria

May 22, 2017

First Posted Date

May 23, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2017

Last Update Posted Date

May 23, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Critical care pain observation tool (CPOT)	Diagnostic Test	test validity and reliability of Thai-version CPOT and BPS		Behavioral pain scale (BPS)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Postoperative Mechanically Ventilated Adult ICU Patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Siriraj Hospital		Bangkok Noi	Bangkok	10700	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided