NCT07268352

The Effect of Ventilation Frequency on Diaper Dermatitis Recovery and Maternal Self-Efficacy in Infants Aged 0-3 Months: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Istanbul University - Cerrahpasa · Academic / Other
• Sex: All
• Age: 0 Months – 12 Months
• Healthy volunteers: Not accepted

Summary

Brief Summary Title: The Effect of Ventilation Frequency on Diaper Dermatitis Recovery and Maternal Self-Efficacy in Infants Aged 0-3 Months: A Randomized Controlled Trial Authors: Fatma Şule Bilgiç, Aysu Yıldız Karaahmet, Shahla Shafaati Laleh Background: Diaper dermatitis (DD) is a prevalent condition affecting infants aged 0-3 months, causing discomfort for both infants and parents. While traditional management focuses on skin protection, the role of ventilation in recovery is not well-studied. This trial investigates the impact of different ventilation frequencies on diaper dermatitis healing and maternal self-efficacy. Methods: A randomized controlled trial included 130 infants with mild diaper dermatitis, divided into two groups: Group A (5 minutes of diaper-free air exposure 6 times a day) and Group B (5 minutes of exposure 12 times a day). Recovery was assessed using the Uncomplicated Diaper Dermatitis Severity Rating Scale (UDDSRSI) and maternal self-efficacy was measured with the Perceived Maternal Self-Efficacy Scale (PMSS). Keywords: Diaper dermatitis, ventilation, maternal self-efficacy, infant care, randomized controlled trial.

Detailed description

Detailed Description Title: The Effect of Ventilation Frequency on Diaper Dermatitis Recovery and Maternal Self-Efficacy in Infants Aged 0-3 Months: A Randomized Controlled Trial Background: Diaper dermatitis (DD) is a prevalent skin condition in infants, particularly affecting those aged 0-3 months. It is characterized by inflammation, redness, and irritation in the diaper area, which can lead to significant discomfort for the infant and distress for the caregivers. Traditional management strategies focus on skin protection through frequent diaper changes, proper hygiene practices, and the use of barrier creams. However, the potential benefits of increased ventilation in the diaper area have not been sufficiently explored. This study aims to evaluate how varying frequencies of diaper-free air exposure can influence the recovery of diaper dermatitis and the perceived self-efficacy of mothers caring for affected infants. Methods: A randomized controlled trial was conducted at a private hospital's Pediatric Outpatient Clinic over a year, from January 2023 to January 2024. A total of 130 infants diagnosed with mild diaper dermatitis were recruited and randomly assigned to two intervention groups: Group A: Received 5 minutes of diaper-free air exposure 6 times a day. Group B: Received 5 minutes of diaper-free air exposure 12 times a day. Data were collected at baseline and upon resolution of diaper dermatitis using: Uncomplicated Diaper Dermatitis Severity Rating Scale (UDDSRSI): This scale assesses the severity of diaper dermatitis based on criteria such as erythema, papules, and skin breakdown. Perceived Maternal Self-Efficacy Scale (PMSS): This scale evaluates mothers' confidence in their caregiving abilities. Data Collection Process: The study involved a comprehensive data collection process, including a detailed questionnaire about sociodemographic characteristics and infant health status. Mothers were trained on proper diaper cleaning techniques and the importance of ventilation in managing diaper dermatitis through a structured educational session. Keywords: Diaper dermatitis, ventilation, maternal self-efficacy, infant care, randomized controlled trial.

Conditions

• Family-centered Care

Interventions

Type	Name	Description
BEHAVIORAL	Diaper-Free Air Exposure Protocol"	The Diaper-Free Air Exposure Protocol is designed to promote the healing of mild diaper dermatitis in infants through structured periods of diaper-free time. This intervention consists of allowing infants to be without a diaper for specific durations throughout the day, aiming to enhance airflow to the affected area and reduce moisture accumulation, which can exacerbate skin irritation. Duration and Frequency: Infants will be exposed to diaper-free intervals lasting 5 minutes each. The intervention will be implemented with varying frequencies based on the study group: 6 times daily for Group A and 12 times daily for Group B. Environment: The diaper-free periods will take place in a safe and comfortable environment, ensuring that the infants are not exposed to potential hazards (e.g., cold surfaces, unsanitary conditions). Caregivers will be instructed to monitor the infants during these periods to ensure their safety and comfort.

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-12-29
• Completion: 2024-01-01
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: Turkey (Türkiye)