Active and Passive Distraction in Children Undergoing Wound Dressings

This study has been completed.
Sponsor:
Information provided by:
Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier:
NCT01224340
First received: October 13, 2010
Last updated: October 19, 2010
Last verified: May 2007
  Purpose

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.


Condition Intervention
Minor Trauma
Behavioral: lollipop
Behavioral: serious games
Other: control

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

Further study details as provided by Sahlgrenska University Hospital, Sweden:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 60
Study Start Date: May 2008
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Experimental: 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. The player got points for collected fishes but also credits for time of flying and speed.
Behavioral: 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.
Experimental: control
The participants in the control group were offered standard care without any specific distraction techniques, except consolation by the acting staff.
Other: control
The participants in the control group were offered standard care without any specific distraction techniques, except consolation by the acting staff.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01224340

Locations
Sweden
The Queen Silvia Children's Hospital, Sahlgrenska University Hospital
Gothenburg, Sweden, 416 85
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01224340     History of Changes
Other Study ID Numbers: Sahlgrenska Hospital
Study First Received: October 13, 2010
Last Updated: October 19, 2010
Health Authority: Sweden:Department of Pediatric Anesthesia and Intensive Care Unit, The Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Göteborg, Sweden

ClinicalTrials.gov processed this record on July 31, 2014