Van Regional Training and Research Hospital
Van, Turkey, 65090, Turkey (Türkiye)
NCT Number: NCT07313735
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.
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Notify Me6 year–11 year
All sexes
Interventional
Not applicable
Van, Turkey, 65090, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
Time frame: Baseline (immediately before burn dressing) and immediately after burn dressing procedure
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.
Time frame: Baseline (immediately before burn dressing) and immediately after burn dressing procedure
Assessed using the Wong-Baker Faces Pain Scale. Measures self-reported pain intensity, scored from 0 (no pain) to 10 (worst pain).
Time frame: Baseline (immediately before burn dressing) and during burn dressing procedure
Heart rate measured using a bedside monitor as an indicator of physiological stress response.
Time frame: Baseline (immediately before burn dressing) and during burn dressing procedure
Respiratory rate measured as breaths per minute to assess physiological stress.
Time frame: Baseline (immediately before burn dressing) and immediately after burn dressing procedure
Peripheral oxygen saturation measured using pulse oximetry to assess physiological response.
Time frame: Baseline (immediately before burn dressing) and immediately after burn dressing procedure
Body temperature measured to evaluate physiological stress response during the procedure.
Yuzuncu Yil University
Other
Acronym: CALM-BURN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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