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
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Condition or disease |
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Postoperative Pain |
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 |
- 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
- 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
- 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
- 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.
- 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

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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 |
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

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
Norway | |
Telemark Hospital | |
Skien, Telemark, Norway, N-3710 |
Study Chair: | Leena Jylli, PhD | Karolinska Institutet |
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 |
COMFORT behavioral scale pain assessment scale child validity reliability |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations |