The Effect of Cartoon Character-Printed Band Use During Burn Dressing on Fear, Stress, Pain, and Physiological Parameters in Children: A Randomized Controlled Trial (CALM-BURN)

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.

Study Overview

• Status: Completed
• Conditions: Burns; Stress, Psychological; Child; Pain, Procedural; Fear; Bandages
• Intervention / Treatment: Other: Cartoon-printed band application; Other: Standard band application

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Turkey
    • Van, Turkey, Turkey (Türkiye), 65090
      • Van Regional Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cartoon character-printed band; Children receiving burn dressing with cartoon character-printed elastic bands.	Other: Cartoon-printed band application; 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.
Active Comparator: Standard Band Group; Children receiving burn dressing with standard plain elastic bands.	Other: Standard band application; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline (immediately before burn dressing) and immediately after burn dressing procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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.	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.	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.	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.	Baseline (immediately before burn dressing) and immediately after burn dressing procedure

Collaborators and Investigators

• Sponsor: Yuzuncu Yil University

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2025
• Primary Completion (Actual): March 12, 2026
• Study Completion (Actual): March 12, 2026

Study Registration Dates

• First Submitted: December 10, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 2, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Burn dressing; Pediatric nursing; Nonpharmacological pain management; Distraction techniques; Cartoon character bandages
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Behavioral Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Pain, Procedural; Stress, Psychological; Burns
• Other Study ID Numbers: YUZUNCU_YIL_UNIVERSITY_cartoon

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: De-identified individual participant data (IPD) and supporting documents, including study protocol and data dictionary, will be available from June 2026 (after completion of data collection and initial analyses) and will remain accessible for 5 years.
• IPD Sharing Access Criteria: Access to the IPD and supporting information will be granted to researchers with a legitimate research proposal approved by the principal investigator. Researchers will be able to access de-identified fear, stress, pain scores, physiological parameters, and associated study documentation through secure data transfer methods. Data will be used solely for scientific research purposes, and a signed data use agreement will be required.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No