The Effect of Ventilation Frequency on Diaper Dermatitis Recovery and Maternal Self-Efficacy in Infants Aged 0-3 Months: A Randomized Controlled Trial
NCT ID: NCT07268352
Last Updated: 2025-12-05
Study Results
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Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2023-01-01
2024-01-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Group A: "Diaper-Free Ventilation: 5 Minutes, 6 Times Daily
This arm of the study focuses on providing infants with diaper-free air exposure as a method to improve recovery from diaper dermatitis. In this group, participants are given the opportunity to be without a diaper for a duration of 5 minutes, and this process is repeated six times throughout the day.
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.
Group B: "Diaper-Free Ventilation: 5 Minutes, 12 Times Daily"
This arm of the study focuses on a more frequent approach to providing infants with diaper-free air exposure as a method to facilitate healing from diaper dermatitis. In this group, participants experience diaper-free intervals for a duration of 5 minutes, repeated twelve times throughout the day.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Infants must exhibit mild to moderate diaper dermatitis as assessed by the Modified Diaper Dermatitis Severity Index (MDDSI) at baseline.
* Written informed consent must be obtained from the parent or legal guardian prior to participation in the study.
* Infants must be in overall good health, without any significant medical conditions that would interfere with the study or require additional treatment for skin conditions.
Exclusion Criteria
* Infants who have received topical treatments (e.g., antifungals, corticosteroids) for diaper dermatitis or other skin conditions within the past 2 weeks prior to enrollment.
* Infants with significant health issues, such as immunosuppression, chronic skin conditions, or other comorbidities that may affect the skin's integrity.
* Infants currently enrolled in other clinical trials or studies that may influence the outcomes of this study.
0 Months
12 Months
ALL
No
Sponsors
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Istanbul University - Cerrahpasa
OTHER
Responsible Party
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Shahla Shafaati Laleh
Principal Investigator
Locations
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Biruni University
Zeytinburnu, None Selected, Turkey (Türkiye)
Countries
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Other Identifiers
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SSL&AYK
Identifier Type: -
Identifier Source: org_study_id
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