Adult ICU PatientsNCT03164525
Validation of the Thai Version CPOT and BPS in Postoperative ICU Patients
An observational study of Adult ICU Patients, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult ICU Patients
- What is being tested?
- Critical care pain observation tool (CPOT)
- How many people
- 27 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2015to 15 Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Postoperative Mechanically Ventilated Adult ICU Patients
Who may be able to join
- aged ≥18 years
- be able to communicate in Thai
- intubated during postoperative period.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital
Bangkok Noi, Bangkok, 10700
About this study
Official title: 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.
Read the 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.
- Conditions
- Adult ICU Patients
- Being tested
- Critical care pain observation tool (CPOT)
- Keywords
- Thai version, validated, Critical Care Pain Observation Tool, Behavioral Pain Scale, adult ICU patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Critical care pain observation tool (CPOT)Diagnostic test
Also called Behavioral pain scale (BPS)
test validity and reliability of Thai-version CPOT and BPS
What is being measured
The primary outcome is the main question the study is designed to answer.
construct validity
Measured: before and after analgesic given during 24 hours postoperative period
Secondary outcomes (1)
content validity, concurrent validity, inter-rater reliability, and practicality
Measured: 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start1 Oct 2015
- Primary completion15 Jul 2016
- Study completion15 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult ICU PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karuna Wongtangman, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164525
- Sponsor's protocol ID
- Si553/2014
- Status last verified
- May 2017
- First submitted
- 22 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Thai Version Critical Care Pain Observation Tool and Behavioral Pain Scale in Postoperative Mechanically Ventilated ICU Patients
- ClinicalTrials.gov ID
- NCT03164525
- Acronym / sponsor ID
- Si553/2014
- Conditions
- Adult ICU Patients
- Keywords
- Thai version, validated, Critical Care Pain Observation Tool, Behavioral Pain Scale, adult ICU patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 15 Jul 2016 (actual)
- Study completion
- 15 Sep 2016 (actual)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Postoperative Mechanically Ventilated Adult ICU Patients
Key inclusion criteria (3 listed)
- aged ≥18 years
- be able to communicate in Thai
- intubated during postoperative period.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Critical care pain observation tool (CPOT)Also: Behavioral pain scale (BPS)test validity and reliability of Thai-version CPOT and BPS | Diagnostic test | – |
Primary outcome
construct validity
Time frame: before and after analgesic given during 24 hours postoperative period
1 secondary outcome
content validity, concurrent validity, inter-rater reliability, and practicality
Time frame: 24 hours after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adult ICU Patients, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
construct validity (time frame: before and after analgesic given during 24 hours postoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.