BurnsCALM-BURNNCT07313735
The Effect of Cartoon Character-Printed Band Use During Burn Dressing on Fear, Stress, Pain, and Physiological Parameters in Children: A Randomized Controlled Trial
A study testing Cartoon-printed band application and Standard band application in people with Burns and Pain, Procedural, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of using cartoon character-printed medical bands during burn dressing procedures on children's fear, stress, pain, and physiological parameters. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Burns, Pain, Procedural, Stress, Psychological
- What is being tested?
- Cartoon-printed band application and Standard band application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Aug 2025to 12 Mar 2026
- 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 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6 to 11 years at the time of enrollment.
- Hospitalized children diagnosed with superficial partial-thickness or deep partial-thickness burns (second-degree burns).
- Total Burned Body Surface Area (TBSA) ≤ 10%, calculated using the Rule of Nines or Lund-Browder chart.
- Burn location limited to upper extremities, lower extremities, or trunk.
- Scheduled to undergo routine burn dressing procedures in the pediatric ward.
- Ability of the child to communicate pain and anxiety verbally.
- Written informed consent obtained from parent or legal guardian, and assent from the child when appropriate.
Who cannot join
- Children with full-thickness (third-degree) or fourth-degree burns.
- Burns involving the face, scalp, neck, or genital region.
- TBSA > 10%.
- Presence of cognitive impairment, developmental delay, or neurological disorder that may interfere with outcome assessment.
- Presence of chronic pain conditions or regular use of analgesics unrelated to burn treatment.
- Initial burn dressing performed in an intensive care unit (ICU).
- Refusal of the child or parent/legal guardian to participate.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Regional Training and Research Hospital
Van, Turkey, 65090
About this study
This randomized controlled trial aims to evaluate the effect of using cartoon character-printed medical bands during burn dressing procedures on children's fear, stress, pain, and physiological parameters. Burn dressing is often a distressing and painful procedure for pediatric patients, which may lead to increased anxiety, physiological instability, and negative treatment experiences.
In this study, child-friendly cartoon-printed adhesive bands are used as a non-pharmacological intervention to provide distraction and emotional comfort during burn dressing. By incorporating familiar and visually engaging designs, the intervention seeks to reduce children's perception of pain, alleviate stress, and improve physiological stability (heart rate, oxygen saturation, and respiratory rate) during the procedure.
Read more
Participants will include children aged 7-11 years receiving burn care in a pediatric burn unit. They will be randomly assigned to either the intervention group (cartoon-printed band use) or the control group (standard plain band use). Fear, pain, and stress will be assessed using validated scales before, during, and after the dressing procedure. Physiological parameters will be measured using a pulse oximeter.
The study is expected to contribute to the development of child-centered, non-pharmacological methods that make medical procedures less stressful and more tolerable for pediatric patients. Results may guide the design of more comforting and engaging treatment environments in pediatric burn care.
Read the detailed description
Burn injuries are among the most common causes of hospitalization in children and often require repeated painful dressing changes. These procedures can provoke significant fear, stress, and pain, negatively affecting children's cooperation, recovery, and overall treatment experience. Traditional approaches to pain management in burn care frequently rely on pharmacological methods, which may have limitations or adverse effects. Therefore, complementary, non-pharmacological interventions are needed to support children during painful procedures.
The CARE-BURN Trial investigates the impact of using cartoon character-printed adhesive bands as a simple, visual, and child-friendly distraction tool during burn dressing. The intervention is designed to create a more comforting and engaging environment for the child by integrating familiar cartoon images into the medical materials. The visual appeal of the bands is expected to distract children's attention from the painful stimulus, enhance their sense of security, and reduce anxiety and perceived pain intensity.
This randomized controlled study includes children aged 7-11 years who are receiving inpatient or outpatient burn treatment. Participants will be randomly assigned using the Urn randomization method to one of two groups:
Intervention Group: Dressing with cartoon character-printed adhesive bands
Control Group: Dressing with standard plain adhesive bands
Measurements:
Children's Fear Scale (CFS)
Wong-Baker FACES Pain Rating Scale
Perceived Stress Scale for Children (PSS-C)
Physiological parameters: heart rate, oxygen saturation, and respiratory rate
Assessments will be conducted at three time points: before, during, and after the dressing procedure. All data will be collected by trained researchers using standardized procedures.
The expected outcomes include decreased levels of fear, stress, and pain, as well as improved physiological stability among children in the intervention group compared to the control group.
The CARE-BURN study aims to demonstrate that low-cost, visually appealing, and child-centered materials can enhance the comfort and cooperation of pediatric patients during invasive or painful treatments. This approach may provide practical insights for pediatric nurses and healthcare providers seeking to humanize burn care and reduce children's distress during routine medical procedures.
- Conditions
- Burns, Pain, Procedural, Stress, Psychological, Fear, Child, Bandages
- Being tested
- Cartoon-printed band application, Standard band application
- Keywords
- Burn dressing, Distraction techniques, Cartoon character bandages, Nonpharmacological pain management, Pediatric nursing
- Medical subject headings
- Burns, Pain, Procedural, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cartoon-printed band applicationOther
Colorful cartoon character-printed elastic adhesive bands will be applied during a single burn dressing procedure. The bands will be applied by the researcher nurse immediately before and throughout the burn dressing process and will remain in place for the entire duration of the dressing procedure. This intervention will be applied during one burn dressing session in the study period to reduce fear, pain, stress, and physiological responses in children.
Standard band applicationOther
Children in this group will receive burn dressing using standard plain elastic adhesive bands. The bands will be applied by the researcher nurse immediately before and throughout a single burn dressing procedure and will remain in place for the entire duration of the dressing process. No additional distraction or visual intervention will be provided during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Cartoon character-printed band | Experimental | Children receiving burn dressing with cartoon character-printed elastic bands. Receives: Other: Cartoon-printed band application |
| Standard Band Group | Active comparator | Children receiving burn dressing with standard plain elastic bands. Receives: Other: Standard band application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear Level Assessed by the Children's Fear Scale
Assessed using the Children's Fear Scale . Measures the level of fear experienced by children during burn dressing procedures, scored from 0 (no fear) to 4 (highest fear).
Measured: Baseline (immediately before burn dressing) and immediately after burn dressing procedure
Secondary outcomes (6)
Stress Level Assessed by the Perceived Stress Scale for Children (PeSSKi)
Assessed using the Perceived Stress Scale for Children (PeSSKi, ages 7-11). Measures children's perceived stress during the procedure, scored on a 5-point Likert scale, with higher scores indicating higher stress.
Measured: Baseline (immediately before burn dressing) and immediately after burn dressing procedure
Pain Intensity Assessed by the Wong-Baker Faces Pain Scale
Assessed using the Wong-Baker Faces Pain Scale. Measures self-reported pain intensity, scored from 0 (no pain) to 10 (worst pain).
Measured: Baseline (immediately before burn dressing) and immediately after burn dressing procedure
Heart Rate During Burn Dressing
Heart rate measured using a bedside monitor as an indicator of physiological stress response.
Measured: Baseline (immediately before burn dressing) and during burn dressing procedure
Respiratory Rate During Burn Dressing
Respiratory rate measured as breaths per minute to assess physiological stress.
Measured: Baseline (immediately before burn dressing) and during burn dressing procedure
Oxygen Saturation During Burn Dressing
Peripheral oxygen saturation measured using pulse oximetry to assess physiological response.
Measured: Baseline (immediately before burn dressing) and immediately after burn dressing procedure
Body Temperature During Burn Dressing
Body temperature measured to evaluate physiological stress response during the procedure.
Measured: Baseline (immediately before burn dressing) and immediately after burn dressing procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start12 Aug 2025
- Primary completion12 Mar 2026
- Study completion12 Mar 2026
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 BurnsStudies 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
- This study uses a randomized, parallel assignment design. Eligible pediatric burn patients are randomly allocated into two groups using the Urn randomization method to ensure balanced distribution. This method will involve two parameters (α and β) represented by two different colored balls. The white ball will represent the intervention group, and the blue ball will represent the control group. The intervention group will receive burn dressing using cartoon character-printed adhesive bands, while the control group will receive standard plain adhesive bands. Both groups will undergo the same dressing procedures performed by trained nurses. Outcomes related to fear, stress, pain, and physiological parameters will be measured before, during, and after the intervention to evaluate the effects of the cartoon-printed bands.
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rıdvan Akdogan, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313735
- Sponsor's protocol ID
- YUZUNCU_YIL_UNIVERSITY_cartoon
- Acronym
- CALM-BURN
- Status last verified
- May 2026
- First submitted
- 10 Dec 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data from this study, including fear, stress, pain scores, and physiological parameters, will be made available to other researchers upon reasonable request. Data will be accessible for research purposes only, following approval by the principal investigator, and will be shared through secure data transfer methods. A data dictionary and study protocol will also be provided to facilitate secondary analyses.
Publications
Akdogan R, Aslan Ozdemir D, Sir O. The effect of cartoon character-printed band use during burn dressing on fear, stress, pain, and physiological parameters in children: A randomized controlled trial. J Pediatr Nurs. 2026 Sep 3;91:617-627. doi: 10.1016/j.pedn.2026.08.066. Online ahead of print.
PubMed 42691681
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cartoon Character-Printed Band Use During Burn Dressing on Fear, Stress, Pain, and Physiological Parameters in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07313735
- Acronym / sponsor ID
- CALM-BURN / YUZUNCU_YIL_UNIVERSITY_cartoon
- Conditions
- Burns, Pain, Procedural, Stress, Psychological, Fear, Child, Bandages
- Keywords
- Burn dressing, Distraction techniques, Cartoon character bandages, Nonpharmacological pain management, Pediatric nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 12 Aug 2025 (actual)
- Primary completion
- 12 Mar 2026 (actual)
- Study completion
- 12 Mar 2026 (actual)
- First posted
- 2 Jan 2026 (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.
This randomized controlled trial aims to evaluate the effect of using cartoon character-printed medical bands during burn dressing procedures on children's fear, stress, pain, and physiological parameters. Burn dressing is often a distressing and painful procedure for pediatric patients, which may lead to increased anxiety, physiological instability, and negative treatment experiences.
In this study, child-friendly cartoon-printed adhesive bands are used as a non-pharmacological intervention to provide distraction and emotional comfort during burn dressing. By incorporating familiar and visually engaging designs, the intervention seeks to reduce children's perception of pain, alleviate stress, and improve physiological stability (heart rate, oxygen saturation, and respiratory rate) during the procedure.
Participants will include children aged 7-11 years receiving burn care in a pediatric burn unit. They will be randomly assigned to either the intervention group (cartoon-printed band use) or the control group (standard plain band use). Fear, pain, and stress will be assessed using validated scales before, during, and after the dressing procedure. Physiological parameters will be measured using a pulse oximeter.
The study is expected to contribute to the development of child-centered, non-pharmacological methods that make medical procedures less stressful and more tolerable for pediatric patients. Results may guide the design of more comforting and engaging treatment environments in pediatric burn care.
Detailed description
Burn injuries are among the most common causes of hospitalization in children and often require repeated painful dressing changes. These procedures can provoke significant fear, stress, and pain, negatively affecting children's cooperation, recovery, and overall treatment experience. Traditional approaches to pain management in burn care frequently rely on pharmacological methods, which may have limitations or adverse effects. Therefore, complementary, non-pharmacological interventions are needed to support children during painful procedures.
The CARE-BURN Trial investigates the impact of using cartoon character-printed adhesive bands as a simple, visual, and child-friendly distraction tool during burn dressing. The intervention is designed to create a more comforting and engaging environment for the child by integrating familiar cartoon images into the medical materials. The visual appeal of the bands is expected to distract children's attention from the painful stimulus, enhance their sense of security, and reduce anxiety and perceived pain intensity.
This randomized controlled study includes children aged 7-11 years who are receiving inpatient or outpatient burn treatment. Participants will be randomly assigned using the Urn randomization method to one of two groups:
Intervention Group: Dressing with cartoon character-printed adhesive bands
Control Group: Dressing with standard plain adhesive bands
Measurements:
Children's Fear Scale (CFS)
Wong-Baker FACES Pain Rating Scale
Perceived Stress Scale for Children (PSS-C)
Physiological parameters: heart rate, oxygen saturation, and respiratory rate
Assessments will be conducted at three time points: before, during, and after the dressing procedure. All data will be collected by trained researchers using standardized procedures.
The expected outcomes include decreased levels of fear, stress, and pain, as well as improved physiological stability among children in the intervention group compared to the control group.
The CARE-BURN study aims to demonstrate that low-cost, visually appealing, and child-centered materials can enhance the comfort and cooperation of pediatric patients during invasive or painful treatments. This approach may provide practical insights for pediatric nurses and healthcare providers seeking to humanize burn care and reduce children's distress during routine medical procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a randomized, parallel assignment design. Eligible pediatric burn patients are randomly allocated into two groups using the Urn randomization method to ensure balanced distribution. This method will involve two parameters (α and β) represented by two different colored balls. The white ball will represent the intervention group, and the blue ball will represent the control group. The intervention group will receive burn dressing using cartoon character-printed adhesive bands, while the control group will receive standard plain adhesive bands. Both groups will undergo the same dressing procedures performed by trained nurses. Outcomes related to fear, stress, pain, and physiological parameters will be measured before, during, and after the intervention to evaluate the effects of the cartoon-printed bands.
| Arm | Type | Receives |
|---|---|---|
| Cartoon character-printed band | Experimental | Other: Cartoon-printed band applicationChildren receiving burn dressing with cartoon character-printed elastic bands. |
| Standard Band Group | Active comparator | Other: Standard band applicationChildren receiving burn dressing with standard plain elastic bands. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 6 to 11 years at the time of enrollment.
- Hospitalized children diagnosed with superficial partial-thickness or deep partial-thickness burns (second-degree burns).
- Total Burned Body Surface Area (TBSA) ≤ 10%, calculated using the Rule of Nines or Lund-Browder chart.
- Burn location limited to upper extremities, lower extremities, or trunk.
- Scheduled to undergo routine burn dressing procedures in the pediatric ward.
Key exclusion criteria (7 listed)
- Children with full-thickness (third-degree) or fourth-degree burns.
- Burns involving the face, scalp, neck, or genital region.
- TBSA > 10%.
- Presence of cognitive impairment, developmental delay, or neurological disorder that may interfere with outcome assessment.
- Presence of chronic pain conditions or regular use of analgesics unrelated to burn treatment.
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 |
|---|---|---|
| Cartoon-printed band applicationColorful cartoon character-printed elastic adhesive bands will be applied during a single burn dressing procedure. The bands will be applied by the researcher nurse immediately before and throughout the burn dressing process and will remain in place for the entire duration of the dressing procedure. This intervention will be applied during one burn dressing session in the study period to reduce fear, pain, stress, and physiological responses in children. | Other | Cartoon character-printed band |
| Standard band applicationChildren in this group will receive burn dressing using standard plain elastic adhesive bands. The bands will be applied by the researcher nurse immediately before and throughout a single burn dressing procedure and will remain in place for the entire duration of the dressing process. No additional distraction or visual intervention will be provided during the procedure. | Other | Standard Band Group |
Primary outcome
Fear Level Assessed by the Children's Fear Scale
Time frame: Baseline (immediately before burn dressing) and immediately after burn dressing procedure
Assessed using the Children's Fear Scale . Measures the level of fear experienced by children during burn dressing procedures, scored from 0 (no fear) to 4 (highest fear).
6 secondary outcomes
Stress Level Assessed by the Perceived Stress Scale for Children (PeSSKi)
Time frame: Baseline (immediately before burn dressing) and immediately after burn dressing procedure
Pain Intensity Assessed by the Wong-Baker Faces Pain Scale
Time frame: Baseline (immediately before burn dressing) and immediately after burn dressing procedure
Heart Rate During Burn Dressing
Time frame: Baseline (immediately before burn dressing) and during burn dressing procedure
Respiratory Rate During Burn Dressing
Time frame: Baseline (immediately before burn dressing) and during burn dressing procedure
Oxygen Saturation During Burn Dressing
Time frame: Baseline (immediately before burn dressing) and immediately after burn dressing procedure
Body Temperature During Burn Dressing
Time frame: Baseline (immediately before burn dressing) and immediately after burn dressing procedure
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 5 May 2026.
- Derived from this study: PubMed 42691681Akdogan R, Aslan Ozdemir D, Sir O. The effect of cartoon character-printed band use during burn dressing on fear, stress, pain, and physiological parameters in children: A randomized controlled trial. J Pediatr Nurs. 2026 Sep 3;91:617-627. doi: 10.1016/j.pedn.2026.08.066. Online ahead of print.
- Individual participant dataSharing planned: Yes. De-identified individual participant data from this study, including fear, stress, pain scores, and physiological parameters, will be made available to other researchers upon reasonable request. Data will be accessible for research purposes only, following approval by the principal investigator, and will be shared through secure data transfer methods. A data dictionary and study protocol will also be provided to facilitate secondary analyses.
Related trials for Burns
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Recruiting
Efferon LPS Hemoadsorption in in Patients With Thermal Burns
Burns
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 Cartoon-printed band application and Standard band application in people with Burns and Pain, Procedural, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 7 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: finished, as of the sponsor's last update on 5 May 2026. 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 Turkey (Türkiye). 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?
Fear Level Assessed by the Children's Fear Scale (time frame: Baseline (immediately before burn dressing) and immediately after burn dressing procedure). 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 NCT07313735, 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 5 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.