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Active and Passive Distraction in Children Undergoing Wound Dressings

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ClinicalTrials.gov Identifier: NCT01224340
Recruitment Status : Completed
First Posted : October 20, 2010
Last Update Posted : October 20, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Minor Trauma Behavioral: lollipop Behavioral: serious games Other: control

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : May 2008
Primary Completion Date : June 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224340


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

ClinicalTrials.gov Identifier: NCT01224340     History of Changes
Other Study ID Numbers: Sahlgrenska Hospital
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: October 20, 2010
Last Verified: May 2007