Active and Passive Distraction in Children Undergoing Wound Dressings

Not Applicable

Completed

• Conditions: Minor Trauma

• Registration Number: NCT01224340
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2007-05
• Study Start: 2008-05
• Primary Completion: 2010-06
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-19
• Last Update Submitted: 2010-10-19
• Study First Posted: 2010-10-20
• Last Update Posted: 2010-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-reported pain intensity is measured on a Coloured Analogue Scale	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.

Trial Locations

Locations (1)

The Queen Silvia Children's Hospital, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden