Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 11:04 AM
Study NCT ID:
NCT07313735
Status:
RECRUITING
Last Update Posted:
2026-01-02
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Yuzuncu Yil University
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CALM-BURN
Brief 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. 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: