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Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale

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ClinicalTrials.gov Identifier: NCT01181687
Recruitment Status : Completed
First Posted : August 13, 2010
Last Update Posted : February 13, 2013
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Geir Hoff, Sykehuset Telemark

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

Condition or disease
Postoperative Pain

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
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale
Study Start Date : January 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Convergent validity of the Comfort behavioral scale [ Time Frame: Within 24 hours after admission to the hospital for surgery ]
    The correlations between each of the items of the scale and between each item and the overall Comfort behavioral scale-score will be calculated

  2. Inter-rater reliability of the Comfort behavioral scale [ Time Frame: Within 24 hours after admission to the hospital for surgery ]
    Calculate the inter-rater reliability among nurses for the Norwegian version of the Comfort behavioral scale

  3. Reduction in Comfort behavioral scale score (2) [ Time Frame: Within 24 hours after admission to the hospital for surgery ]
    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.

  4. Reduction in Comfort behavioral scale score (1) [ Time Frame: Within 24 hours after admission to the hospital for surgery ]
    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


Eligibility Criteria
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Ages Eligible for Study:   40 Weeks to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children admitted to Telemark Hospital (level II hospital) and meeting the inclusion and exclusion criteria specified
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01181687


Locations
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Norway
Telemark Hospital
Skien, Telemark, Norway, N-3710
Sponsors and Collaborators
Sykehuset Telemark
Karolinska Institutet
Investigators
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Study Chair: Leena Jylli, PhD Karolinska Institutet
More Information
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Responsible Party: Geir Hoff, Professor, Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT01181687    
Other Study ID Numbers: 2010/1268 (REK)
First Posted: August 13, 2010    Key Record Dates
Last Update Posted: February 13, 2013
Last Verified: February 2013
Keywords provided by Geir Hoff, Sykehuset Telemark:
COMFORT behavioral scale
pain assessment scale
child
validity
reliability
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
 Pain
Neurologic Manifestations
Signs and Symptoms