Pediatrics · Medical Literature
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
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. A two-arm parallel cluster randomized controlled trial. 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). 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. 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. This protocol is adhered to the EQUATOR Network's SPIRIT 2025 statement. No patient or public contribution. PACTR202512767733948.
Clinical relevance
In informal caregiver–neonate dyads cared for in neonatal intensive care units, does a nurse-led, touch-based intervention grounded in caring theory improve informal caregivers' engagement and their perceptions of nurse support compared to standard care? __SNAPSHOT__ {"studyDesign":"Protocol for a two-arm parallel cluster randomized controlled trial (cRCT); no results reported","setting":"Neonatal intensive care units (NICUs); country and specific institution type not reported in the abstract","sampleSize":"Planned: n = 228 informal caregiver–neonate dyads","population":"Informal caregiver–neonate dyads recruited from NICUs; stratified by NICU level and neonate health status category. Specific inclusion/exclusion criteria beyond these stratification variables are not reported in the abstract.","intervention":"Nurse-led, touch-based intervention grounded in caring theory, delivered during neonatal nursing care (specific components, dose, frequency, and duration of the intervention are not reported in the abstract)","comparator":"Control group (described as standard or usual care; specific control condition not detailed in the abstract)","primaryOutcome":"Informal caregivers' levels of engagement during neonatal nursing care (measurement instrument not specified in the abstract)","followUp":"Two time-points: baseline (cohort one survey) and impact assessment (cohort two survey); interval duration not reported in the abstract","fundingSource":"Not reported"}
Key findings
This publication describes a study protocol only. No efficacy or safety data have been collected or reported. No primary outcome results, effect sizes, confidence intervals, p-values, or adverse event data are available. The anticipated primary outcome is informal caregivers' engagement, and the secondary outcome is caregivers' perceptions of nurse support. Statistical analysis plans, anticipated effect sizes used for sample size calculation, and NNT/NNH are not reported in the abstract. Results cannot be summarized at this time.
Practice implications
Because this is a protocol paper, no conclusions about intervention effectiveness can yet be drawn. The study has not established that the nurse-led, touch-based intervention improves caregiver engagement or perceptions of nursing support; these remain the hypotheses to be tested. The trial is specifically designed to address informal caregivers (which may include family members other than parents) of neonates across varying acuity levels in the NICU, a population with limited high-quality RCT evidence on structured engagement interventions. Clinicians should note that the abstract is the only available source; the full protocol document may contain critical methodological details—including the intervention manual, measurement tools, sample size calculation assumptions, and planned statistical analyses—that are not accessible for this summary. No change in clinical practice is warranted or possible based on a protocol publication. This limitation is noted explicitly. __LIMITATIONS__ Protocol publication only: no outcome data exist; all findings are prospective and hypothetical at this stage.,Only the abstract was available for review; key protocol details (intervention fidelity procedures, specific measurement instruments, power calculation assumptions, blinding strategy, and statistical analysis plan) could not be independently verified.,Cluster randomization introduces the risk of contamination between arms within shared NICU environments and requires appropriate intraclass correlation coefficient (ICC) adjustment, the adequacy of which cannot be assessed from the abstract.,Sample size of 228 dyads may be underpowered for subgroup analyses by neonate health status or NICU level; power assumptions are not reported in the abstract.,Blinding: participant and caregiver blinding is unlikely to be feasible in a touch-based behavioral intervention, introducing performance and detection bias; the abstract does not address assessor blinding.,Generalizability is uncertain: country of study, institutional resources, and staffing ratios are not reported, limiting applicability to other healthcare systems.,Use of two separate survey cohorts (baseline vs. impact assessment) rather than a single longitudinal cohort may introduce cohort effect confounding and limits within-subject change tracking.,Caregiver engagement and perception of support are patient-reported and psychosocial outcomes; their relationship to hard neonatal clinical endpoints (mortality, length of stay, neurodevelopment) is not addressed in the protocol abstract.,Funding source is not reported, precluding assessment of potential conflicts of interest. __BOTTOM_LINE_CATEGORY__ not_ready_for_clinical_application __BOTTOM_LINE__ This paper describes a protocol for a cluster RCT evaluating a nurse-led, touch-based NICU intervention on informal caregiver engagement and perceived nurse support; no efficacy data are available. Clinicians should monitor the trial for results before considering any practice change. The design is methodologically relevant, but meaningful clinical conclusions must await publication of outcome data.