Completed

NCT Number: NCT01224340

Active and Passive Distraction in Children Undergoing Wound Dressings

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.

Completed

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Key information

Conditions

Minor Trauma

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Queen Silvia Children's Hospital, Sahlgrenska University Hospital

Gothenburg, 416 85, Sweden

Who can participate

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

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.

Treatment and study plan

lollipop

Behavioral

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

Behavioral

The serious game chosen, Tux Racer, contented a penguin that collected fishes at the same time as it did slalom in a path.

Control

Other

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

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.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital