Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale
This study has been completed.
Sponsor:
Sykehuset Telemark
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
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Purpose
The purpose of this study is to establish reliability and validity of the Norwegian version of the Comfort behavioral scale.
| Condition |
|---|
|
Postoperative Pain |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale |
Further study details as provided by Sykehuset Telemark:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Enrollment: | 50 |
| Study Start Date: | January 2011 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 40 Weeks to 3 Years |
| Genders Eligible for Study: | Both |
| 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 More Information
No publications provided
| Responsible Party: | Geir Hoff, Professor, Sykehuset Telemark |
| ClinicalTrials.gov Identifier: | NCT01181687 History of Changes |
| Other Study ID Numbers: | 2010/1268 (REK) |
| Study First Received: | August 3, 2010 |
| Last Updated: | February 12, 2013 |
| Health Authority: | Norway: Directorate of Health Norway: Ethics Committee Norway: Norwegian Social Science Data Services Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by Sykehuset Telemark:
|
COMFORT behavioral scale pain assessment scale child validity reliability |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013