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Clinical Trials/NCT01224340
NCT01224340
Completed
Not Applicable

Active and Passive Distraction in Children Undergoing Wound Dressings

Sahlgrenska University Hospital, Sweden1 site in 1 country60 target enrollmentMay 2008
ConditionsMinor Trauma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Minor Trauma
Sponsor
Sahlgrenska University Hospital, Sweden
Enrollment
60
Locations
1
Primary Endpoint
Self-reported pain intensity is measured on a Coloured Analogue Scale
Status
Completed
Last Updated
15 years ago

Overview

Brief Summary

The hypothesis was that an active distraction is more effective than a passive distraction in conjunction with procedural pain in children. The specific aim in this study was to test how an active distraction, serious gaming and a passive distraction, the use of lollipops influence pain, distress and anxiety in children during wound care.

Registry
clinicaltrials.gov
Start Date
May 2008
End Date
June 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Sahlgrenska University Hospital, Sweden

Eligibility Criteria

Inclusion Criteria

  • Children aged five to twelve were recruited from the pediatric day care unit at the Queen Silvia Children's hospital, Gothenburg, Sweden. Included children had wounds that differed in size and location but were too extensive to be handled in a primary care setting. The wound dressing procedures were standardized and the pain experiences were expected to be similar in all included children.

Exclusion Criteria

  • Children with longstanding wounds, care-related pressure wounds, and wounds in body areas with decreased sensitivity were excluded from this study.Children with cognitive impairments were excluded from the study, as were children or parents who did not have a good command of Swedish.

Outcomes

Primary Outcomes

Self-reported pain intensity is measured on a Coloured Analogue Scale

Time Frame: Primary outcome, i.e. pain intensity during the wound dressing, is recorded after one wound dressing, an average time on 20 minutes.

Primary outcome and calculation of sample size is based on self-reported pain scores. Data will be collected in conjunction with the children's first visit to the specialized wound care nurse after the trauma. Pain intensity as primary outcome is recorded at one occasion; pain intensity during the procedure is recorded after the wound care.

Study Sites (1)

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