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Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale

This study has been completed.
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Geir Hoff, Sykehuset Telemark
ClinicalTrials.gov Identifier:
NCT01181687
First received: August 3, 2010
Last updated: February 12, 2013
Last verified: February 2013

August 3, 2010
February 12, 2013
January 2011
September 2011   (final data collection date for primary outcome measure)
Increase in Comfort behavioral scale score [ Time Frame: Within 24 hours after admission to the hospital for surgery ] [ Designated as safety issue: No ]
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
  • Increase in Comfort behavioral scale score [ Time Frame: Within 48 hours after admission to the hospital for surgery ] [ Designated as safety issue: No ]
    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
  • Reduction in Comfort behavioral scale score [ Time Frame: Within 48 hours after admission to the hospital for surgery ] [ Designated as safety issue: No ]
    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
Complete list of historical versions of study NCT01181687 on ClinicalTrials.gov Archive Site
  • Convergent validity of the Comfort behavioral scale [ Time Frame: Within 24 hours after admission to the hospital for surgery ] [ Designated as safety issue: No ]
    The correlations between each of the items of the scale and between each item and the overall Comfort behavioral scale-score will be calculated
  • Inter-rater reliability of the Comfort behavioral scale [ Time Frame: Within 24 hours after admission to the hospital for surgery ] [ Designated as safety issue: No ]
    Calculate the inter-rater reliability among nurses for the Norwegian version of the Comfort behavioral scale
  • Reduction in Comfort behavioral scale score (2) [ Time Frame: Within 24 hours after admission to the hospital for surgery ] [ Designated as safety issue: No ]
    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.
  • Reduction in Comfort behavioral scale score (1) [ Time Frame: Within 24 hours after admission to the hospital for surgery ] [ Designated as safety issue: No ]
    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
  • Convergent validity of the Comfort behavioral scale [ Time Frame: Within 48 hours after admission to the hospital for surgery ] [ Designated as safety issue: No ]
    The correlations between each of the items of the scale and between each item and the overall Comfort behavioral scale-score will be calculated
  • Inter-rater reliability of the Comfort behavioral scale [ Time Frame: Within 48 hours after admission to the hospital for surgery ] [ Designated as safety issue: No ]
    Calculate the inter-rater reliability among nurses for the Norwegian version of the Comfort behavioral scale
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Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale
Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Children admitted to Telemark Hospital (level II hospital) and meeting the inclusion and exclusion criteria specified

Postoperative Pain
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
October 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
40 Weeks to 3 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01181687
2010/1268 (REK)
No
Geir Hoff, Sykehuset Telemark
Sykehuset Telemark
Karolinska Institutet
Study Chair: Leena Jylli, PhD Karolinska Institutet
Sykehuset Telemark
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP