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Completed

NCT Number: NCT01181687

Psychometric Testing of the Norwegian Version of the Comfort Behavioral Scale

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

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

40 week–3 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Telemark Hospital

Skien, Telemark, N-3710, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Sykehuset Telemark

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 13, 2010
Registry last updated
Feb 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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