Pain, AcuteDISTRACTNCT06933303
Distraction as Treatment for Pain in Children in Resource-scarce Settings
A study testing Distraction with kaleidoscope in people with Pain, Acute, run by Vrinnevi Hospital at 1 site in South Africa.
Trial summary
Pain alleviation in pediatric patients can be challenging for medical professionals working in resource scarce settings due to limited availability of medication, monitoring equipment, or training in this field of expertise. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Distraction with kaleidoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSouth Africa
- Study dates
- 30 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients between the age of 7 and 12 years old with burn injuries requiring dressing changes in the outpatient clinic, who in regular practice (non-research setting) would not receive any analgesics;
- Type of burn injury: partial thickness burns with a burned area not greater than 10% at the moment of the first dressing change measurement as part of this research
Who cannot join
- Patients who received split skin grafts for their burns;
- Patients on sedatives or anti-epileptics;
- The use of pain-relieving medication other than paracetamol or ibuprofen;
- Painful additional injuries other than the burn injury;
- Patients who are nursed in isolation;
- Physical or mental impairments which make it impossible to adequately comply with the trial protocol. For example, visual impairments, impaired ability to communicate, psychological comorbidities, and burns that limit the use of a kaleidoscope (facial burns or burns to both hands);
- Retrospective exclusion if the patient in the intervention group did not look through the kaleidoscope for more than 50% of the procedure time.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Africa1 site, 1 recruiting
- Recruiting
Ngwelezana Hospital
Empangeni, KwaZulu-Natal, 3880
Ravi Naidoo, MD, PhD, +27359017000, ravi@drnaidoo.co.za
Ravi Naidoo, MD, PhD
About this study
Pain alleviation in pediatric patients can be challenging for medical professionals working in resource scarce settings due to limited availability of medication, monitoring equipment, or training in this field of expertise. This poses the need for a readily available tool for pain reduction that does not rely on expensive equipment or medication and which can easily be applied in resource scarce settings around the world. With this research project we aim to assess the effectiveness of a simple, inexpensive, non-electronic distraction method: a kaleidoscope, to reduce acute pain in pediatric patients undergoing dressing changes in resource scarce environments.
A randomized controlled trial will be performed at the Edendale Hospital in Pietermaritzburg KwaZulu Natal, South Africa. Pediatric patients between the age of 7-12 years with partial thickness burn injuries who require dressing changes in the outpatient clinic will be randomized into two groups: one group (control) will receive standard practice of care which concerns a dressing change without any pain alleviation other than paracetamol or a non-steroidal anti inflammatory drug (NSAID), and one group (intervention) will receive distraction by use of a kaleidoscope as method for potential pain alleviation on top of standard medical care. The primary outcome will be the difference in mean change in pain score (from before to during the dressing change) between the control and distraction group.
This study is expected to demonstrate that the use of a non-electronic distraction technique effectively alleviates pain in children undergoing dressing changes and that its use is feasible in low resource settings. The distraction technique can be applied as add-on to pharmacological treatment, or stand-alone when no pharmacological treatment is available. Distraction is expected to be safe and can even be applied by an accompanying parent, resulting in lower barriers for healthcare workers to apply it. Appropriate pain relief will improve psychological wellbeing of pediatric patients undergoing painful procedures, and it might even improve recovery and physical rehabilitation since pain has been associated with physical as well as mental morbidity.
- Conditions
- Pain, Acute
- Being tested
- Distraction with kaleidoscope
- Keywords
- Distraction, Pain, Burn injury, Dressing change, Pediatric
- Medical subject headings
- Acute Pain, Pain, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction with kaleidoscopeDevice
During the intervention measurement, the pediatric patient will be distracted by the use of a kaleidoscope during the procedure. Distraction by use of the kaleidoscope will be initiated at the start of the procedure (dressing change) and the kaleidoscope will be offered until at least a minute after the procedure is completed. Removal of the dressing will be started when the child seems distracted as indicated by response with a smile or laughter, or a verbal response
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Undergoing dressing change with standard medical care. Standard medical care can include: no pain alleviation methods; paracetamol; non-steroidal anti-inflammatory drug; combination of paracetamol with non-steroidal anti-inflammatory drug |
| Distraction | Experimental | Undergoing dressing change with standard medical care (as described above for Control arm), combined with distraction by use of a kaleidoscope as a possible pain alleviation method. Receives: Device: Distraction with kaleidoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain score
The change (increase) in pain scores (the Wong-Baker FACES Pain Rating Scale and the FLACC scale), 0 (less pain)-10 (more pain) , from prior to the dressing change to during the dressing change
Measured: Pain scores measured five minutes prior to dressing change; pain score during dressing change, measured immediately after removal of the dressing
Secondary outcomes (5)
Postprocedural pain score decrease
Change in mean pain scores (the Wong-Baker FACES Pain Rating Scale and the FLACC scale), 0 (less pain)-10 (more pain) , when comparing scores during with scores after the procedure.
Measured: Pain scores during dressing change, after removal of the dressing; pain score at five minutes after dressing change
Heart rate
Change/course of heart rate before, during and after dressing change
Measured: Measured five minutes before dressing change; measured during dressing change at two-minute interval; measured five minutes after dressing change
Oxygen saturation
Change/course of blood oxygen levels before, during and after dressing change
Measured: Measured five minutes before dressing change; measured during dressing change at two-minute interval; measured five minutes after dressing change
Global satisfaction
Global judgement of satisfaction with treatment by caregiver and medical professional, will be measured on a 1 (very dissatisfied)-5 (very satisfied) scale based on the question: "Considering pain relief, side effects, and emotional status, how satisfied were you with the dressing change the child underwent?"
Measured: Five minutes after dressing change
Procedure time
Procedure time (seconds), reflecting procedure efficiency/patient cooperation
Measured: Duration of dressing change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start30 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- 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
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vrinnevi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Radboud University Medical Center, Linkoeping University, University of KwaZulu
- Responsible party
- Principal investigator, Måns Muhrbeck MD, PhD, Vrinnevi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933303
- Sponsor's protocol ID
- DISTRACT-01
- Acronym
- DISTRACT
- Status last verified
- Apr 2025
- First submitted
- 8 Apr 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distraction as Treatment for Pain in Children in Resource-scarce Settings
- ClinicalTrials.gov ID
- NCT06933303
- Acronym / sponsor ID
- DISTRACT / DISTRACT-01
- Conditions
- Pain, Acute
- Keywords
- Distraction, Pain, Burn injury, Dressing change, Pediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Vrinnevi HospitalUniversity, hospital or other
- Collaborators
- Radboud University Medical Center, Linkoeping University, University of KwaZulu
- Study start
- 30 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Apr 2025 (actual)
- 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.
Pain alleviation in pediatric patients can be challenging for medical professionals working in resource scarce settings due to limited availability of medication, monitoring equipment, or training in this field of expertise. This poses the need for a readily available tool for pain reduction that does not rely on expensive equipment or medication and which can easily be applied in resource scarce settings around the world. With this research project we aim to assess the effectiveness of a simple, inexpensive, non-electronic distraction method: a kaleidoscope, to reduce acute pain in pediatric patients undergoing dressing changes in resource scarce environments.
A randomized controlled trial will be performed at the Edendale Hospital in Pietermaritzburg KwaZulu Natal, South Africa. Pediatric patients between the age of 7-12 years with partial thickness burn injuries who require dressing changes in the outpatient clinic will be randomized into two groups: one group (control) will receive standard practice of care which concerns a dressing change without any pain alleviation other than paracetamol or a non-steroidal anti inflammatory drug (NSAID), and one group (intervention) will receive distraction by use of a kaleidoscope as method for potential pain alleviation on top of standard medical care. The primary outcome will be the difference in mean change in pain score (from before to during the dressing change) between the control and distraction group.
This study is expected to demonstrate that the use of a non-electronic distraction technique effectively alleviates pain in children undergoing dressing changes and that its use is feasible in low resource settings. The distraction technique can be applied as add-on to pharmacological treatment, or stand-alone when no pharmacological treatment is available. Distraction is expected to be safe and can even be applied by an accompanying parent, resulting in lower barriers for healthcare workers to apply it. Appropriate pain relief will improve psychological wellbeing of pediatric patients undergoing painful procedures, and it might even improve recovery and physical rehabilitation since pain has been associated with physical as well as mental morbidity.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Undergoing dressing change with standard medical care. Standard medical care can include: no pain alleviation methods; paracetamol; non-steroidal anti-inflammatory drug; combination of paracetamol with non-steroidal anti-inflammatory drug |
| Distraction | Experimental | Device: Distraction with kaleidoscopeUndergoing dressing change with standard medical care (as described above for Control arm), combined with distraction by use of a kaleidoscope as a possible pain alleviation method. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients between the age of 7 and 12 years old with burn injuries requiring dressing changes in the outpatient clinic, who in regular practice (non-research setting) would not receive any analgesics;
- Type of burn injury: partial thickness burns with a burned area not greater than 10% at the moment of the first dressing change measurement as part of this research
Key exclusion criteria (7 listed)
- Patients who received split skin grafts for their burns;
- Patients on sedatives or anti-epileptics;
- The use of pain-relieving medication other than paracetamol or ibuprofen;
- Painful additional injuries other than the burn injury;
- Patients who are nursed in isolation;
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 |
|---|---|---|
| Distraction with kaleidoscopeDuring the intervention measurement, the pediatric patient will be distracted by the use of a kaleidoscope during the procedure. Distraction by use of the kaleidoscope will be initiated at the start of the procedure (dressing change) and the kaleidoscope will be offered until at least a minute after the procedure is completed. Removal of the dressing will be started when the child seems distracted as indicated by response with a smile or laughter, or a verbal response | Device | Distraction |
Primary outcome
Change in pain score
Time frame: Pain scores measured five minutes prior to dressing change; pain score during dressing change, measured immediately after removal of the dressing
The change (increase) in pain scores (the Wong-Baker FACES Pain Rating Scale and the FLACC scale), 0 (less pain)-10 (more pain) , from prior to the dressing change to during the dressing change
5 secondary outcomes
Postprocedural pain score decrease
Time frame: Pain scores during dressing change, after removal of the dressing; pain score at five minutes after dressing change
Heart rate
Time frame: Measured five minutes before dressing change; measured during dressing change at two-minute interval; measured five minutes after dressing change
Oxygen saturation
Time frame: Measured five minutes before dressing change; measured during dressing change at two-minute interval; measured five minutes after dressing change
Global satisfaction
Time frame: Five minutes after dressing change
Procedure time
Time frame: Duration of dressing change
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distraction with kaleidoscope in people with Pain, Acute, run by Vrinnevi Hospital at 1 site in South Africa.
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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 18 Apr 2025. 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 South Africa. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Måns Muhrbeck Senior surgical consultant, MD, PhD (46-703338852, mans.muhrbeck@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain score (time frame: Pain scores measured five minutes prior to dressing change; pain score during dressing change, measured immediately after removal of the dressing). 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 18 Apr 2025.