Effectiveness of Nurse‐Led, Touch‐Based Intervention in Improving Informal Caregivers' Engagement and Perceptions of Nurse Support During Neonatal Nursing Care: Protocol for Cluster Randomized Controlled Trial

Abstract

AIM: To report study protocol on the effectiveness of a nurse-led, touch-based intervention grounding in caring theory in improving informal caregivers' engagement and perceptions of nurse support during neonatal nursing care. DESIGN: A two-arm parallel cluster randomized controlled trial. METHODS: This study will involve 228 informal caregiver-neonate dyads recruited from neonatal intensive care units. A multi-level block stratification randomization will be used to assign both neonatal intensive care units (by level) and participants (by neonate's health status category) to either the experimental or control group. The primary outcome for this study is informal caregivers' levels of engagement, and their perceptions of nurses' support are considered a secondary outcome. Data will be collected in two surveys: the baseline (cohort one survey) and the impact assessment (cohort two survey). IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: This study will evaluate potentially effective intervention to promote bonding between informal caregivers and neonates. The approach will improve informal caregivers' engagement and perceptions of nursing support, which will lead to the optimization of high-acuity neonatal nursing care and, ultimately, the improvement of clinical outcomes for both informal caregivers and neonates. Overall, this study is highly relevant to neonatal intensive care unit nurses. It improves the quality of care and delivers valuable practical and theoretical insights. IMPACT: No previous studies have reported interventions specifically designed to address informal caregiver engagement in neonatal nursing or their perceptions of support. This study serves as the first cluster randomized controlled trial to evaluate a nurse-led, theory-driven intervention aimed at improving both caregiver engagement and perceptions of nursing support. These findings will generate new knowledge regarding nurse-led, touch-based care grounded in established caring theories, effectively bridging the gap between theoretical models and clinical practice in resource-limited settings. REPORTING METHOD: This protocol is adhered to the EQUATOR Network's SPIRIT 2025 statement. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution. TRIAL REGISTRATION: PACTR202512767733948.