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

NCT07313735 | Completed

• 1 other identifier: YUZUNCU_YIL_UNIVERSITY_cartoon
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Pain, Procedural; Stress, Psychological; Fear; Child; Bandages

Keywords

Burn dressing; Distraction techniques; Cartoon character bandages; Nonpharmacological pain management; Pediatric nursing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Stress Level Assessed by the Perceived Stress Scale for Children (PeSSKi)

  Baseline (immediately before burn dressing) and immediately after burn dressing procedure

• Pain Intensity Assessed by the Wong-Baker Faces Pain Scale

  Baseline (immediately before burn dressing) and immediately after burn dressing procedure

• Heart Rate During Burn Dressing

  Baseline (immediately before burn dressing) and during burn dressing procedure

• Respiratory Rate During Burn Dressing

  Baseline (immediately before burn dressing) and during burn dressing procedure

• Oxygen Saturation During Burn Dressing

  Baseline (immediately before burn dressing) and immediately after burn dressing procedure

Study Arms (2)

Cartoon character-printed band

EXPERIMENTAL

Children receiving burn dressing with cartoon character-printed elastic bands.

Other: Cartoon-printed band application

Standard Band Group

ACTIVE COMPARATOR

Children receiving burn dressing with standard plain elastic bands.

Other: Standard band application

Interventions

Cartoon-printed band application OTHER

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.

Cartoon character-printed band

Standard band application OTHER

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.

Standard Band Group

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Regional Training and Research Hospital

Van, Turkey, 65090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Burns; Pain, Procedural; Stress, Psychological

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study. Participants, care providers, and outcome assessors will be aware of group allocation due to the visible appearance of the cartoon character-printed bands used during the burn dressing procedure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. (PhD)

Model Details: 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.

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: January 2, 2026
• Study Start: August 12, 2025
• Primary Completion: March 12, 2026
• Study Completion: March 12, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

TU (1)