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

NCT07268352 | Completed

• 1 other identifier: SSL&AYK
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diaper dermatitis; ventilation; maternal self-efficacy; infant care; randomized controlled trial.

Outcome Measures

Primary Outcomes (1)

• Severity of diaper dermatitis in infants measured by the Modified Diaper Dermatitis Severity Index (MDDDSI)

  Skin assessments conducted at baseline and weekly using MDDDSI. Scoring criteria: erythema, edema, erosion, papules, exudate. Each item scored 0-3; higher scores indicate more severe dermatitis. Total score used to determine overall severity.

  Baseline and weekly assessments for 6 weeks during intervention

Secondary Outcomes (1)

• Maternal self-efficacy measured by the Perceived Maternal Self-Efficacy Scale (PMSS)

  Maternal self-efficacy will be assessed using the Perceived Maternal Self-Efficacy Scale (PMSS), a validated 20-item 4-point Likert scale (range: 20-80). Higher scores indicate greater perceived maternal self-efficacy. The scale will be administered at b

Study Arms (2)

Group A: "Diaper-Free Ventilation: 5 Minutes, 6 Times Daily

ACTIVE COMPARATOR

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.

Behavioral: Diaper-Free Air Exposure Protocol"

Group B: "Diaper-Free Ventilation: 5 Minutes, 12 Times Daily"

ACTIVE COMPARATOR

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.

Behavioral: Diaper-Free Air Exposure Protocol"

Interventions

Diaper-Free Air Exposure Protocol" BEHAVIORAL

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 A: "Diaper-Free Ventilation: 5 Minutes, 6 Times Daily; Group B: "Diaper-Free Ventilation: 5 Minutes, 12 Times Daily"

Eligibility Criteria

• Age: 0 Months - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged from 0 months (newborn) to 12 months.
• 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.

You may not qualify if:

• Infants with severe diaper dermatitis or other dermatological conditions affecting the diaper area (e.g., fungal infections, bacterial infections, or other rashes) will be excluded.
• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Biruni University

Zeytinburnu, None Selected, 34445, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diaper Rash; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 5, 2025
• Study Start: January 1, 2023
• Primary Completion: December 29, 2023
• Study Completion: January 1, 2024
• Last Updated: December 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)