Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale

NCT ID: NCT01181687

Last Updated: 2013-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Postoperative Pain

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

40 Weeks

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Sykehuset Telemark

OTHER_GOV

Sponsor Role lead

Responsible Party

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Geir Hoff

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leena Jylli, PhD

Role: STUDY_CHAIR

Karolinska Institutet

Locations

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Telemark Hospital

Skien, Telemark, Norway

Site Status

Countries

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Norway

Other Identifiers

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2010/1268 (REK)

Identifier Type: -

Identifier Source: org_study_id

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