Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale

Study Overview
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Brief Summary
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The purpose of this study is to establish reliability and validity of the Norwegian version of the Comfort behavioral scale.

Detailed Description
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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.

Official Title
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Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale

Conditions
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Postoperative Pain

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Younger than 3 years old at the time of surgery Day care patients admitted for minor elective surgery Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Weeks
Maximum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Within 24 hours after admission to the hospital for surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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 | Within 24 hours after admission to the hospital for surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COMFORT behavioral scale, pain assessment scale, child, validity, reliability