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
  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

Resource links provided by NLM:


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)
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181687

Locations
Norway
Telemark Hospital
Skien, Telemark, Norway, N-3710
Sponsors and Collaborators
Sykehuset Telemark
Karolinska Institutet
Investigators
Study Chair: Leena Jylli, PhD Karolinska Institutet
  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 September 30, 2014