Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale

Postoperative Pain Clinical Trial

Official title:

Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181687
• Other study ID #: 2010/1268 (REK)
• Status: Completed
• Phase: N/A
• First received: August 3, 2010
• Last updated: February 12, 2013
• Start date: January 2011
• Est. completion date: October 2011

Study information

• Verified date: February 2013
• Source: Sykehuset Telemark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Directorate of HealthNorway: Ethics CommitteeNorway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Weeks to 3 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Locations

Country	Name	City	State
Norway	Telemark Hospital	Skien	Telemark

Sponsors (2)

Lead Sponsor	Collaborator
Sykehuset Telemark	Karolinska Institutet

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No