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

NCT07268352 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-12-05

No results posted yet for this study

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.

Conditions

  • Family-centered Care

Interventions

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.

Sponsors & Collaborators

  • Istanbul University - Cerrahpasa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
0 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-12-29
Completion
2024-01-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07268352 on ClinicalTrials.gov