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

November 25, 2025 updated by: Shahla Shafaati Laleh, Istanbul University - Cerrahpasa

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
130

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • None Selected
      • Zeytinburnu, None Selected, Turkey (Türkiye), 34445
        • Biruni University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Severity of diaper dermatitis in infants measured by the Modified Diaper Dermatitis Severity Index (MDDDSI)
Time Frame: Baseline and weekly assessments for 6 weeks during intervention

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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maternal self-efficacy measured by the Perceived Maternal Self-Efficacy Scale (PMSS)
Time Frame: 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
Baseline and at dermatitis recovery (average 1-3 days after intervention)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul University - Cerrahpasa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SSL&AYK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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