Pain, AcuteDISTRACTNCT06591195
Distraction As Multimodal Pain Management
A study testing Distraction by use of kaleidoscope in people with Pain, Acute and Burns, run by Radboud University Medical Center.
Trial summary
A randomized controlled trial will be performed at the Ngwelezana Hospital, Empangeni, South Africa. Paediatric patients between the age of 5-12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomized into two groups… Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Pain, Acute, Burns, Pediatric ALL
- What is being tested?
- Distraction by use of kaleidoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Oct 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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients between the age of 5 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 other than paracetamol or a non-steroidal anti-inflammatory drug (NSAID);
- Superficial partial thickness burns < 5% TBSA (total body surface area) at the time of injury
- Only the first change of dressing is included
Who cannot join
- Patients who underwent split skin grafts for their burns;
- Patients on sedatives or anti-epileptics;
- The use of pain-relieving medication other than paracetamol or NSAIDs;
- If it is the patient's second presentation to Ngwelezana hospital's outpatient burns department
- Painful additional injuries other than the burn injury;
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Distraction As Multimodal Pain Management for Children in Resource-constrained Settings (DISTRACT)
A randomized controlled trial will be performed at the Ngwelezana Hospital, Empangeni, South Africa. Paediatric patients between the age of 5-12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomized into two groups: the control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as additional method for potential pain alleviation. Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when required according to hospital protocol. The primary outcome will be the change in pain score from pre-procedural to pain score during the dressing change and will be analysed with a linear regression analysis. Additionally, sub analyses will be performed to evaluate potentially modifying factors on the treatment effect. This will also be evaluated with a linear regression analysis. This will be correlated with care giver and health care worker observational pain scores.
- Conditions
- Pain, Acute, Burns, Pediatric ALL
- Being tested
- Distraction by use of kaleidoscope
- Keywords
- Distraction, Pain treatment, Pediatric burn injury, Dressing change
- Medical subject headings
- Acute Pain, Burns, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distraction by use of kaleidoscopeDevice
À kaleidoscope is an optical device consisting of mirrors that reflect images of bits of coloured glass in a symmetrical geometric design through a viewer.
A kaleidoscope was selected as the non-electronic method of distraction, because of its wide availability due to low costs, its evolving and colourful visual stimuli, the fact that is blocks out any visualisations from the environment when used properly, and because it requires active participation (i.e., greater attention) from the subject.
| Study group | Role | What they receive |
|---|---|---|
| Distraction | Experimental | The intervention group will undergo a dressing change procedure with distraction by use of a kaleidoscope as additional method for pain alleviation. In both groups, patients will receive paracetamol or non-steroidal anti-inflammatory drugs when required according to hospital protocol. Receives: Device: Distraction by use of kaleidoscope |
| Control | No intervention | The control group will undergo the standard dressing change procedure without additional distraction methods. In both groups, patients will receive paracetamol or non-steroidal anti-inflammatory drugs when required according to hospital protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in patient-reported pain score
The patient-reported pain score after the dressing change minus the pain score before the procedure. This pain score is rated on the Wong-Baker FACES Pain Rating Scale from 0-10.
Measured: Baseline, before wound cleaning (0 minutes) and after dressing change (within 10 minutes)
Secondary outcomes (2)
Observational pain score
The observational pain score is measured during the dressing change on the Face, Legs, Activity, Cry and Consolability (FLACC) scale from 0 to 10. This score is corrected by the baseline (patiënt-reported) pain score before the dressing change.
Measured: During the dressing change procedure (0 minutes to 5 minutes)
Global satisfaction with treatment
Global satisfaction about the treatment is assessed among the patient's caregiver and healthcare provider. Global satisfaction will be rated on a 1-5 scale based on the question: "Considering pain relief, side effects, and emotional status, how satisfied were you with the dressing change your child underwent?\"
Measured: After dressing change (within 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Paediatric patients between the age of 5-12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomized into two groups: the control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as additional method for potential pain alleviation. Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when required according to hospital protocol.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ravi Naidoo, MD, Principal investigator, General surgeon, head of Burns Unit at Ngwelezana Hospital, Empangeni, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591195
- Sponsor's protocol ID
- BREC/00005194/2023
- Acronym
- DISTRACT
- Status last verified
- Aug 2024
- First submitted
- 3 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haverkamp FJC, Naidoo R, Muhrbeck M, Pompermaier L, Wladis A, van Laarhoven CJHM, Tan ECTH. DISTRACT study: evaluating kaleidoscope distraction as part of multimodal pain management in paediatric dressing changes - study protocol of a single centre randomised trial. BMJ Open. 2025 Jul 28;15(7):e093761. doi: 10.1136/bmjopen-2024-093761.
PubMed 40721257
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distraction As Multimodal Pain Management for Children in Resource-constrained Settings (DISTRACT)
- ClinicalTrials.gov ID
- NCT06591195
- Acronym / sponsor ID
- DISTRACT / BREC/00005194/2023
- Conditions
- Pain, Acute, Burns, Pediatric ALL
- Keywords
- Distraction, Pain treatment, Pediatric burn injury, Dressing change
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
A randomized controlled trial will be performed at the Ngwelezana Hospital, Empangeni, South Africa. Paediatric patients between the age of 5-12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomized into two groups: the control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as additional method for potential pain alleviation. Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when required according to hospital protocol. The primary outcome will be the change in pain score from pre-procedural to pain score during the dressing change and will be analysed with a linear regression analysis. Additionally, sub analyses will be performed to evaluate potentially modifying factors on the treatment effect. This will also be evaluated with a linear regression analysis. This will be correlated with care giver and health care worker observational pain scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Paediatric patients between the age of 5-12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomized into two groups: the control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as additional method for potential pain alleviation. Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when required according to hospital protocol.
| Arm | Type | Receives |
|---|---|---|
| Distraction | Experimental | Device: Distraction by use of kaleidoscopeThe intervention group will undergo a dressing change procedure with distraction by use of a kaleidoscope as additional method for pain alleviation. In both groups, patients will receive paracetamol or non-steroidal anti-inflammatory drugs when required according to hospital protocol. |
| Control | No intervention | –The control group will undergo the standard dressing change procedure without additional distraction methods. In both groups, patients will receive paracetamol or non-steroidal anti-inflammatory drugs when required according to hospital protocol. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients between the age of 5 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 other than paracetamol or a non-steroidal anti-inflammatory drug (NSAID);
- Superficial partial thickness burns < 5% TBSA (total body surface area) at the time of injury
- Only the first change of dressing is included
Key exclusion criteria (6 listed)
- Patients who underwent split skin grafts for their burns;
- Patients on sedatives or anti-epileptics;
- The use of pain-relieving medication other than paracetamol or NSAIDs;
- If it is the patient's second presentation to Ngwelezana hospital's outpatient burns department
- Painful additional injuries other than the burn injury;
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 by use of kaleidoscopeÀ kaleidoscope is an optical device consisting of mirrors that reflect images of bits of coloured glass in a symmetrical geometric design through a viewer. A kaleidoscope was selected as the non-electronic method of distraction, because of its wide availability due to low costs, its evolving and colourful visual stimuli, the fact that is blocks out any visualisations from the environment when used properly, and because it requires active participation (i.e., greater attention) from the subject. | Device | Distraction |
Primary outcome
The difference in patient-reported pain score
Time frame: Baseline, before wound cleaning (0 minutes) and after dressing change (within 10 minutes)
The patient-reported pain score after the dressing change minus the pain score before the procedure. This pain score is rated on the Wong-Baker FACES Pain Rating Scale from 0-10.
2 secondary outcomes
Observational pain score
Time frame: During the dressing change procedure (0 minutes to 5 minutes)
Global satisfaction with treatment
Time frame: After dressing change (within 10 minutes)
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 19 Sep 2024.
- Derived from this study: PubMed 40721257Haverkamp FJC, Naidoo R, Muhrbeck M, Pompermaier L, Wladis A, van Laarhoven CJHM, Tan ECTH. DISTRACT study: evaluating kaleidoscope distraction as part of multimodal pain management in paediatric dressing changes - study protocol of a single centre randomised trial. BMJ Open. 2025 Jul 28;15(7):e093761. doi: 10.1136/bmjopen-2024-093761.
- Individual participant dataSharing planned: No
Related trials for Pain, Acute
Not yet recruiting
Testing the Timing and Application of Virtual Reality Distraction During Knee Injections in a VA Pain Clinic
Pain Management, Injection Pain Prevention
Active, not recruiting
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Coronary Artery Disease
Active, not recruiting
Impact of Vitamin C on opioïd Consumption After an Emergency Department Visit for Acute Musculoskeletal Pain
Pain, Acute
Not yet recruiting
Acute Effects of High-Intensity Laser Therapy on Pain, Muscle Stiffness, and Grip Strength in Healthy Adults
Exercise-Induced Muscle Fatigue, Fatigue Recovery
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
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.
Ravi Naidoo, MD principal investigator
General surgeon, head of Burns Unit at Ngwelezana Hospital, Empangeni, South Africa
Questions about this trial
What is this clinical trial studying?
A study testing Distraction by use of kaleidoscope in people with Pain, Acute and Burns, run by Radboud University Medical Center.
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 3 inclusion and 6 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: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Ravi Naidoo, MD (0027 35 9017000, ravi@drnaidoo.co.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in patient-reported pain score (time frame: Baseline, before wound cleaning (0 minutes) and after dressing change (within 10 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06591195, which also lists 1 linked publication.
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 19 Sep 2024.