NCT07205055

Brief Summary

This study was conducted using a randomized controlled, pretest-posttest comparative experimental design to examine the effects of diaper dermatitis care training provided to primiparous mothers on mothers' knowledge and the severity of diaper dermatitis in infants aged 0-6 months. The study was conducted with a total of 74 primiparous mothers from June to September 2025. Participants were divided into intervention (n=37) and control (n=37) groups. The intervention group received video training on diaper dermatitis care.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2025

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 24, 2025

Last Update Submit

September 24, 2025

Conditions

Keywords

mothereducationvideodiaper dermatitisnapkin dermatitisdiaper rash

Outcome Measures

Primary Outcomes (1)

  • Mothers' Child Care Knowledge and Practice Level Form

    The Mothers' Child Care Knowledge and Practice Level Assessment Form, prepared for use in the research process, was sent to 15 experts via e-mail to measure its content validity. Opinions were received from 10 experts, and these opinions were analyzed using appropriate methods. A three-item structure was used in the evaluation of the Mothers' Child Care Knowledge and Practice Level Assessment Form, which consists of 25 items: "item appropriate," "minor modifications needed," and "item not appropriate." Therefore, the Lawshe (1975) technique was utilized in the expert opinion analysis of the Mothers' Child Care Knowledge and Practice Level Assessment Form. The CVR and CGI values obtained as a result of the analysis are expected to be higher than the criterion value for the 10 experts, CGI=0.62 (Veneziano \& Hooper, 1997). As a result of the analyses, it was determined that the CVR values for the items on the Mothers' Child Care Knowledge and Practice Level Assessment Form were in th

    7 days

Secondary Outcomes (1)

  • Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants

    7 DAYS

Study Arms (2)

study

ACTIVE COMPARATOR

The severity of diaper dermatitis will be monitored by having the mothers in the study group watch a video training session. This will allow for the healing effect to be observed.

Other: video training

CONTROL

NO INTERVENTION

NO APPLICATION WILL BE MADE

Interventions

No study in the literature has examined the effectiveness of video-based diaper dermatitis education.

study

Eligibility Criteria

Age19 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPrimiparous mothers with babies aged 0-6 months
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Infants aged 0-6 months and their mothers who applied to the child health clinic of the city hospital where the study will be conducted,
  • Parents over the age of 19,
  • Volunteering for the study,
  • The mother is an only child,
  • Having at least a primary school degree,

You may not qualify if:

  • Babies with chronic illnesses
  • Babies with dermatological or other allergic skin conditions
  • Being a healthcare professional
  • Mothers with a medical condition (physical, neurological, or mental) that prevents them from providing care
  • Those using diapers other than disposable diapers (free of perfume, phthalates, chlorine, dioxin, latex, or parabens)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Lütfi Kırdar City Hospital

Istanbul, kartal, 34870, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diaper Rash

Condition Hierarchy (Ancestors)

Dermatitis, IrritantDermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

September 24, 2025

First Posted

October 3, 2025

Study Start

June 1, 2025

Primary Completion

September 15, 2025

Study Completion

September 18, 2025

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

If anyone wants to do any meta-analysis after the study is published, they can contact me via email.

Locations