Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07410858
Brief Summary:
This randomized pilot clinical trial aims to evaluate the effectiveness and feasibility of virtual reality (VR)-enhanced parent education in improving neonatal intensive care unit (NICU) caregiving practices among parents of hospitalized neonates. The study will also examine the safety and tolerability of VR use among parents.
Researchers will compare VR-enhanced education with standard NICU parent education to determine whether immersive VR training improves parents' knowledge, confidence, and ability to perform caregiving tasks.
Participants will be randomly assigned to receive either VR-enhanced education or standard education. Participants receiving VR education will engage in short immersive sessions demonstrating NICU orientation and caregiving procedures. All participants will complete assessments and observations related to caregiving practices and VR tolerability throughout the study period.
Detailed Description:
The NICU environment presents significant emotional, educational, and practical challenges for parents of preterm or critically ill neonates. Effective parent education is essential for improving caregiving competence, reducing parental anxiety, and supporting family-integrated neonatal care. However, traditional education methods such as verbal instructions and printed materials may be limited by time constraints, parental stress, and variations in health literacy.
Virtual reality technology provides immersive, interactive educational experiences that may enhance understanding, engagement, and retention of caregiving information. VR simulations can provide parents with guided orientation to NICU equipment, caregiving demonstrations, and exposure to real-life caregiving scenarios in a safe, controlled environment.
This study is designed as a single-center, randomized, parallel-group pilot trial conducted in a neonatal intensive care unit setting. The primary purpose of the trial is to evaluate feasibility outcomes including recruitment, adherence, retention, and VR tolerability, as well as to generate preliminary estimates of effect size and variability to inform future large-scale trials.
Participants assigned to the intervention group will receive a standardized VR education package consisting of immersive orientation and caregiving simulation sessions delivered using a VR headset. Sessions will include demonstrations of routine neonatal care activities and structured debriefing discussions to reinforce learning and address parental questions.
Participants assigned to the control group will receive routine NICU parent education delivered through conventional methods currently implemented in clinical practice.
Data collection will include assessments of parental knowledge, direct observation of caregiving practices, and evaluation of VR-related tolerability and user experience. Observations of caregiving practices will be conducted by trained observers who are blinded to group allocation to reduce assessment bias.
The results of this pilot trial will provide essential data regarding feasibility, acceptability, safety, and potential effectiveness of VR-enhanced parent education. Findings will be used to refine intervention procedures, improve study methodology, and support the development of a larger definitive randomized clinical trial aimed at improving neonatal outcomes and family-centered care in NICU settings.
Study:
NCT07410858
Study Brief:
Protocol Section:
NCT07410858