Active and Passive Distraction in Children Undergoing Wound Dressings

Minor Trauma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224340
• Other study ID #: Sahlgrenska Hospital
• Status: Completed
• Phase: N/A
• First received: October 13, 2010
• Last updated: October 19, 2010
• Start date: May 2008

Study information

• Verified date: May 2007
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden:Department of Pediatric Anesthesia and Intensive Care Unit, The Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Göteborg, Sweden
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: June 2010
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Minor Trauma

Intervention

Behavioral:
• lollipop
The lollipops varied in color and each color had its own flavor. The children chose between blue, green, red, orange or yellow lollipop colors. The children started to taste the lollipops approximately three to five minutes before the wound care and continued to do so during the whole session.
• serious games
The serious game chosen, Tux Racer, contented a penguin that collected fishes at the same time as it did slalom in a path.

Other:
• control
The participants in the control group were offered standard care without any specific distraction techniques, except consolation by the acting staff.

Locations

Country	Name	City	State
Sweden	The Queen Silvia Children's Hospital, Sahlgrenska University Hospital	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported pain intensity is measured on a Coloured Analogue Scale	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.	Primary outcome, i.e. pain intensity during the wound dressing, is recorded after one wound dressing, an average time on 20 minutes.	No