--- 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" nct_id: NCT07313735 overall_status: COMPLETED phase: NA sponsor: Yuzuncu Yil University study_type: INTERVENTIONAL primary_condition: Burns countries: Turkey (Türkiye) canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07313735.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07313735" ct_last_update_post_date: 2026-05-05 last_seen_at: "2026-05-12T07:34:40.585Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # The Effect of Cartoon Character-Printed Band Use During Burn Dressing on Fear, Stress, Pain, and Physiological Parameters in Children: A Randomized Controlled Trial **NCT ID:** [NCT07313735](https://clinicaltrials.gov/study/NCT07313735) ## Key Facts - **Status:** COMPLETED - **Phase:** NA - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 42 - **Lead Sponsor:** Yuzuncu Yil University - **Conditions:** Burns, Pain, Procedural, Stress, Psychological, Fear, Child, Bandages - **Start Date:** 2025-08-12 - **Completion Date:** 2026-03-12 - **CT.gov Last Update:** 2026-05-05 ## 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. ## 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. ## Eligibility - **Minimum age:** 6 Years - **Maximum age:** 11 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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. ``` ## Arms - **Cartoon character-printed band** (EXPERIMENTAL) — Children receiving burn dressing with cartoon character-printed elastic bands. - **Standard Band Group** (ACTIVE_COMPARATOR) — Children receiving burn dressing with standard plain elastic bands. ## 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. - **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. ## Primary Outcomes - **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). ## 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)_ ## Locations (1) - Van Regional Training and Research Hospital, Van, Turkey, Turkey (Türkiye) ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.van regional training and research hospital|van|turkey|turkey (türkiye)` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT07313735.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT07313735* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*