Minor TraumaNCT01224340
Active and Passive Distraction in Children Undergoing Wound Dressings
A study testing lollipop and serious games in people with Minor Trauma, run by Sahlgrenska University Hospital at 1 site in Sweden.
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… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Minor Trauma
- What is being tested?
- lollipop and serious games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- May 2008to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
The Queen Silvia Children's Hospital, Sahlgrenska University Hospital
Gothenburg, 416 85
About this study
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.
- Conditions
- Minor Trauma
- Being tested
- lollipop, serious games, control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lollipopBehavioural
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 gamesBehavioural
The serious game chosen, Tux Racer, contented a penguin that collected fishes at the same time as it did slalom in a path.
controlOther
The participants in the control group were offered standard care without any specific distraction techniques, except consolation by the acting staff.
| Study group | Role | What they receive |
|---|---|---|
| lollipop | Experimental | 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. Receives: Behavioral: lollipop |
| serious games | Experimental | 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. Receives: Behavioral: serious games |
| control | Experimental | The participants in the control group were offered standard care without any specific distraction techniques, except consolation by the acting staff. Receives: Other: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Primary outcome, i.e. pain intensity during the wound dressing, is recorded after one wound dressing, an average time on 20 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startMay 2008
- Primary completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minor TraumaStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224340
- Sponsor's protocol ID
- Sahlgrenska Hospital
- Status last verified
- May 2007
- First submitted
- 13 Oct 2010
- Last updated
- 20 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active and Passive Distraction in Children Undergoing Wound Dressings
- ClinicalTrials.gov ID
- NCT01224340
- Acronym / sponsor ID
- Sahlgrenska Hospital
- Conditions
- Minor Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2010 (actual)
- First posted
- 20 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| lollipop | Experimental | Behavioral: lollipopThe 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 | Experimental | Behavioral: serious gamesThe 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. |
| control | Experimental | Other: controlThe participants in the control group were offered standard care without any specific distraction techniques, except consolation by the acting staff. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lollipopThe 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. | Behavioural | lollipop |
| serious gamesThe serious game chosen, Tux Racer, contented a penguin that collected fishes at the same time as it did slalom in a path. | Behavioural | serious games |
| controlThe participants in the control group were offered standard care without any specific distraction techniques, except consolation by the acting staff. | Other | control |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lollipop and serious games in people with Minor Trauma, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2010.