Postoperative PainNCT01181687
Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale
An observational study of Postoperative Pain, run by Sykehuset Telemark at 1 site in Norway.
Trial summary
The purpose of this study is to establish reliability and validity of the Norwegian version of the Comfort behavioral scale. Read more about this study
- Who is it for?
- Ages 40 weeks to 3 years
- Conditions the study is for
- Postoperative Pain
- How many people
- 50 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to Oct 2011
- 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 40 weeks to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Children admitted to Telemark Hospital (level II hospital) and meeting the inclusion and exclusion criteria specified
Who may be able to join
- Younger than 3 years old at the time of surgery
- Day care patients admitted for minor elective surgery
Who cannot join
- Pre-entry use of sedation and/or analgesics
- Neurological or other diseases or drugs (neuromuscular blockers) thet significantly influence motor activity, facial expression, cognition, or emotional state, ex. cerebral palsy, myopathy, severe mental retardation, severe hypotonia, neuromuscular disease
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to establish reliability and validity of the Norwegian version of the Comfort behavioral scale.
Read the detailed description
Structured pain assessment is the foundation for the management of pain. Several different pain measurement tools exists, among them the Comfort behavioral scale (van Dijk, 2005), developed from the original Comfort scale (Ambuel, 1992). The psychometric properties of the Comfort scale have been tested in several studies, but so far no Norwegian version of the scale has been developed and tested. Neither has the scale been tested in spontaneously breathing children undergoing minor surgery. The aim of this study is to establish incipient psychometric properties of the Norwegian version of the scale among children aged 0-3 years admitted for elective minor surgery.
- Conditions
- Postoperative Pain
- Keywords
- COMFORT behavioral scale, pain assessment scale, child, validity, reliability
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in Comfort behavioral scale score
Testing the hypothesis that there will be a clincal significant increase in Comfort-score when the scores from admission and after surgery are compared. The highest registered score obtained during the first 24 hours after surgery will be used for this analysis. We assume that the score at admission reflects no pain/sedation, while the scores after surgery reflect varying degree of pain
Measured: Within 24 hours after admission to the hospital for surgery
Secondary outcomes (4)
Convergent validity of the Comfort behavioral scale
The correlations between each of the items of the scale and between each item and the overall Comfort behavioral scale-score will be calculated
Measured: Within 24 hours after admission to the hospital for surgery
Inter-rater reliability of the Comfort behavioral scale
Calculate the inter-rater reliability among nurses for the Norwegian version of the Comfort behavioral scale
Measured: Within 24 hours after admission to the hospital for surgery
Reduction in Comfort behavioral scale score (2)
Testing the hypothesis that there will be a clinically significant reduction in Comfort-score when the scores from after the administration of pre-medication and after surgery when the child still has a laryngeal mask in place is compared. We assume that the score after premedication is given reflects a light sedation while the scores after surgery when the child still has a laryngela mask in place reflects deep sedation.
Measured: Within 24 hours after admission to the hospital for surgery
Reduction in Comfort behavioral scale score (1)
Testing the hypothesis that there will be a clincal significant reduction in Comfort-score when the scores from admission and after the administration of pre-medication are compared. We assume that the score at admission reflect no pain/sedation, while the scores after pre-medication is given reflect sedation
Measured: Within 24 hours after admission to the hospital for surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2010 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Geir Hoff, Sykehuset Telemark
- Investigators
- Leena Jylli, PhD, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181687
- Sponsor's protocol ID
- 2010/1268 (REK)
- Status last verified
- Feb 2013
- First submitted
- 3 Aug 2010
- Last updated
- 13 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale
- ClinicalTrials.gov ID
- NCT01181687
- Acronym / sponsor ID
- 2010/1268 (REK)
- Conditions
- Postoperative Pain
- Keywords
- COMFORT behavioral scale, pain assessment scale, child, validity, reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sykehuset TelemarkOther government
- Collaborators
- Karolinska Institutet
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 13 Aug 2010 (estimated)
- 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 purpose of this study is to establish reliability and validity of the Norwegian version of the Comfort behavioral scale.
Detailed description
Structured pain assessment is the foundation for the management of pain. Several different pain measurement tools exists, among them the Comfort behavioral scale (van Dijk, 2005), developed from the original Comfort scale (Ambuel, 1992). The psychometric properties of the Comfort scale have been tested in several studies, but so far no Norwegian version of the scale has been developed and tested. Neither has the scale been tested in spontaneously breathing children undergoing minor surgery. The aim of this study is to establish incipient psychometric properties of the Norwegian version of the scale among children aged 0-3 years admitted for elective minor surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 weeks to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children admitted to Telemark Hospital (level II hospital) and meeting the inclusion and exclusion criteria specified
Key inclusion criteria (2 listed)
- Younger than 3 years old at the time of surgery
- Day care patients admitted for minor elective surgery
Key exclusion criteria (2 listed)
- Pre-entry use of sedation and/or analgesics
- Neurological or other diseases or drugs (neuromuscular blockers) thet significantly influence motor activity, facial expression, cognition, or emotional state, ex. cerebral palsy, myopathy, severe mental retardation, severe hypotonia, neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Increase in Comfort behavioral scale score
Time frame: Within 24 hours after admission to the hospital for surgery
Testing the hypothesis that there will be a clincal significant increase in Comfort-score when the scores from admission and after surgery are compared. The highest registered score obtained during the first 24 hours after surgery will be used for this analysis. We assume that the score at admission reflects no pain/sedation, while the scores after surgery reflect varying degree of pain
4 secondary outcomes
Convergent validity of the Comfort behavioral scale
Time frame: Within 24 hours after admission to the hospital for surgery
Inter-rater reliability of the Comfort behavioral scale
Time frame: Within 24 hours after admission to the hospital for surgery
Reduction in Comfort behavioral scale score (2)
Time frame: Within 24 hours after admission to the hospital for surgery
Reduction in Comfort behavioral scale score (1)
Time frame: Within 24 hours after admission to the hospital for surgery
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 13 Feb 2013.
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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.
Leena Jylli, PhD study chair
Karolinska Institutet
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 Postoperative Pain, run by Sykehuset Telemark at 1 site in Norway.
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 2 inclusion and 2 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 13 Feb 2013. 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 Norway. 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?
Increase in Comfort behavioral scale score (time frame: Within 24 hours after admission to the hospital for surgery). 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 13 Feb 2013.