Nurse-led culturally adapted therapeutic play for reducing procedural distress during outpatient nebulization in children: a pragmatic cluster-randomized controlled trial

Technical Summary: Nurse-Led Culturally Adapted Therapeutic Play for Pediatric Nebulization

Problem Statement
Young children (ages 2–7) frequently experience significant procedural distress during outpatient nebulization for respiratory tract infections. This distress is triggered by mask contact, equipment noise, unfamiliar odors, and the requirement to remain still. Such reactions often manifest as crying, mask refusal, physical resistance, and mask displacement, which can interrupt treatment delivery and increase the burden on staff and caregivers. While non-pharmacological behavioral support, such as therapeutic clowning and play, has shown efficacy in perioperative, inpatient, dental, and venipuncture settings, there is limited evidence regarding its integration into high-turnover outpatient nebulization. Furthermore, traditional clown imagery may be unfamiliar or frightening to some children, necessitating culturally adapted alternatives.

Methodology
The study was a prospective, pragmatic, parallel-group, physician-level cluster-randomized, controlled, open-label, single-center superiority trial conducted at a single hospital in China.

• Participants: 200 children aged 2–7 years requiring outpatient nebulization for respiratory infections.
• Intervention: The "Bear Knight" protocol, a nurse-led, culturally adapted therapeutic play intervention. It replaced traditional clown imagery with a soft plush teddy bear costume to reduce potential fear. The 20-minute session included three phases: pre-nebulization (rapport building, mask desensitization via role-play), intra-nebulization (distraction, breathing guidance, cartoon co-viewing, sticker rewards), and post-nebulization (positive reinforcement).
• Control: Standard care comprising verbal reassurance, parental presence, and cartoon video distraction.
• Design: Allocation was physician-level (randomized by physician group) to prevent contamination within nursing teams. Children were assigned based on the physician they consulted.
• Outcomes:
  • Primary: Day 1 FLACC (Face, Legs, Activity, Cry, Consolability) behavioral pain/distress score.
  • Secondary: Nebulization cooperation score, mask displacement incidents, child FPS-R (Faces Pain Scale-Revised) scores, caregiver anxiety, and nursing satisfaction.
  • Follow-up: Assessments were repeated on Days 2 and 3, treated as exploratory observations.
• Statistical Analysis: Primary analysis used independent two-sample t-tests or Wilcoxon rank-sum tests. A mixed-effects model with a participant-level random intercept was used as a sensitivity analysis for repeated measures. Notably, physician-level cluster identifiers were not retained in the de-identified dataset, preventing cluster-adjusted primary analysis.

Key Results

• Primary Outcome: On Day 1, the intervention group demonstrated significantly lower FLACC scores compared to the control group (1.42 ± 1.89 vs. 2.25 ± 2.09; P < 0.01; Cohen's d = −0.42).
• Secondary Outcomes: The intervention group showed favorable results across all secondary metrics on Day 1:
  • Higher cooperation scores (3.72 vs. 3.33; P = 0.017).
  • Fewer mask displacement incidents (0.28 vs. 0.88; P < 0.01).
  • Lower child FPS-R pain scores (1.53 vs. 2.05; P = 0.02).
  • Lower caregiver anxiety scores (25.63 vs. 27.37; P < 0.01).
• Exploratory Follow-up: Similar directional benefits were observed on Days 2 and 3, with FLACC scores and anxiety levels remaining lower in the intervention group, though these days are considered exploratory due to repeated measures and sample attrition from clinical recovery.
• Subgroup Analysis: The reduction in distress was consistent across sex and age subgroups (<4 years and ≥4 years).
• Safety: No intervention-related adverse events or unintended harms were reported.

Significance and Claims
The authors claim that a nurse-led, culturally adapted therapeutic play intervention may effectively reduce procedure-related distress during the initial outpatient nebulization session for young children. The study suggests this approach offers a feasible, non-pharmacological adjunct for pediatric outpatient care that improves treatment cooperation, mask tolerance, and caregiver anxiety.

The paper explicitly frames these findings as supportive rather than definitive due to specific design limitations:

1. Lack of Cluster Adjustment: Because physician-level cluster identifiers were not retained, the primary analysis could not be adjusted for clustering, potentially underestimating uncertainty.
2. Single-Center Design: Generalizability to other regions or healthcare systems is limited.
3. Open-Label Nature: Participants and staff could not be blinded, though outcome assessment was independent.

Consequently, the authors conclude that while the intervention shows promise, further multicenter trials with retained cluster identifiers and cluster-adjusted analyses are necessary before broader implementation can be recommended. The study positions the "Bear Knight" protocol as a pragmatic adaptation that preserves the core elements of therapeutic play while mitigating the potential fear associated with traditional clown imagery in a specific cultural and clinical context.