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Diaper DermatitisNCT07205055

Effect of Video-Based Diaper Dermatitis Care Education on Mothers' Knowledge Level and Dermatitis Severity: A Randomized Controlled Trial

A study testing video training in people with Diaper Dermatitis and Diaper Rash, run by Uskudar University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older, women onlyHealthy volunteers can take part
What is being tested?
video training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jun 2025to 18 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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,

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Dr. Lütfi Kırdar City Hospital

    Istanbul, kartal, 34870

Other trials in Turkey (Türkiye)

About this study

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.

Read the detailed description

Purpose of Study This study aims to investigate the effects of video diaper dermatitis care training provided to primiparous mothers on diaper dermatitis severity scores and mothers' knowledge levels in 0-6 month-old infants.

Research Type This study is a randomized controlled, pretest-posttest comparative, experimental design to determine the effects of video diaper dermatitis care training provided to primiparous mothers on diaper dermatitis severity scores and mothers' knowledge levels in 0-6 month-old infants.

Place and Time of Study The study was conducted at a city hospital on the Anatolian side of Istanbul. The third floor of this hospital houses seven general pediatrics outpatient clinics, two pediatrics and infection clinics, and two pediatric hematology and oncology outpatient clinics. Services on the outpatient clinic floor include laboratory tests, imaging, health reports, patient admission procedures, well-child follow-up and examination, sick-child follow-up and examination, vaccination follow-up and referral, and lactation and relactation training. This hospital was selected because it is the researcher's affiliated institution and because of its diverse patient population.

The research was conducted between June and September 2025.Research Hypotheses H1: There is no significant difference between the pretest and posttest scores of the Mothers' Child Care Knowledge and Practice Level Assessment Form for the mothers in the control group.

H2: The posttest score of the Mothers' Child Care Knowledge and Practice Level Assessment Form for the mothers in the study group is higher than the pretest score.

H3: The posttest score of the Mothers' Child Care Knowledge and Practice Level Assessment Form for the mothers in the study group is higher than the control group.

H4: The final score of the Infant Uncomplicated Diaper Dermatitis Severity Rating Scale for the infants in the study group is lower than the control group.

H5: The final score of the Infant Uncomplicated Diaper Dermatitis Severity Rating Scale for the infants in the study group is lower than the pretest score.

Research Population and Sample A power analysis was conducted to determine the number of participants to be included in the study. The power of the test was calculated using the G*Power 3.1.9.2 program. In a similar study in the relevant literature, Nur Çelik (2023) calculated the effect size for dermatitis as 0.847. To exceed 95% power, a 5% significance level and an effect size of 0.847 required reaching 62 participants (df=60; t=1.671). Considering the high power of the test and the 20% loss, it was determined that a total of 74 participants (37 in each group) were needed. In the study, 74 mothers were divided into two groups. The first group (n=37 mothers) was the intervention group, which watched an educational video, and the second group (n=37 mothers) was the control group.

Randomized Study Seventy-four primiparous mothers and their infants, aged newborn-six months, who presented to the pediatric outpatient clinic, were registered on the CalculatorSoup website and divided into two groups. The numbers presented in Table 1 were obtained accordingly. Using random numbers generated based on the order of application, mothers and their babies were assigned to groups using a simple random sampling method. The sealed envelope method was used to determine which group the first case would be included in; envelopes were labeled "Intervention" and "Control" and sealed, and group assignment was made based on the contents of the envelope opened for the first case. Participants who declined to participate in the study were included in the first mother in the order. Verbal and written consent was obtained from the randomly assigned participants, and this process continued until the sample size was reached.

Inclusion Criteria for the Study

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

Exclusion Criteria for the Study

Infants with chronic diseases, Infants with dermatological or other allergic skin conditions, Having started complementary feeding, Being a healthcare professional, Mothers having a 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).

Research Implementation Steps

Step 1: Research data were collected through face-to-face interviews. The study population consisted of mothers who applied to the pediatric outpatient clinic of the hospital where the study was conducted, met the research criteria, and volunteered to participate. Verbal and written consent was obtained from the mothers who agreed to participate in the study, and two separate groups were formed using a randomization method. Because participants who received the training might realize they were in the intervention group, the study will be conducted in an open-label, randomized manner. The randomization calculation, calculated via Calculatur.com, was provided to Keskin, the department secretary, and the researcher will not be aware of the intervention and control groups.

Step 2: Mothers in the experimental and control groups completed the "Mother and Baby Identification Form" and the "Mothers' Child Care Knowledge and Practice Level Assessment Form." The baby's diaper dermatitis was assessed at the bedside, and the "Uncomplicated Diaper Dermatitis Severity Assessment Scale (preliminary score)" was completed, and the pre-training severity score was recorded.

Step 3: Mothers in the experimental group watched a diaper dermatitis prevention and care video prepared by the researchers on the first day they arrived at the outpatient clinic and were enrolled in the study. The control group received no treatment. They were only instructed to follow their routine treatments as directed by their physician.

Step 4: In a survey conducted by Yıldız et al. (2023) with 217 pediatricians in 32 different provinces of Türkiye, 39.2% (n=85) of participants responded "7 days later" to the question, "After the initial evaluation, when would you recommend checking a patient with diaper dermatitis?" and 32.3% (n=70) recommended checking "3 days later" (Yıldız et al., 2023).

The mothers and their babies in the experimental and control groups were called to the hospital 7 days after their visit to the outpatient clinic. The "Mothers' Child Care Knowledge and Practice Level Assessment Form" was completed. The infant's diaper dermatitis was assessed at the bedside, and the "Uncomplicated Infant Diaper Dermatitis Severity Assessment Scale (final score)" was completed, and the severity score was recorded after the training.

Step 5: The study was concluded when the sample size was reached. Step 6: After the study was concluded, the mothers in the control group also watched the video training in accordance with ethical principles.

Limitations of the Study

The study was conducted only on mothers and their babies admitted to a single city hospital. The participants reflected specific socioeconomic and sociocultural characteristics, making it difficult to generalize nationwide.

Dependent and Independent Variables of the Study Independent Variables Sociodemographic Characteristics: Mother's age, education level, economic status, baby's gender, age, weight, height, baby's feeding habits, etc.

Video-based educational intervention Dependent Variables BSOBSS score AABBUDF score

Data Analysis of the Study Statistical Package for Social Sciences (SPSS) v27 was used for statistical analysis. Participant characteristics are presented using the number (n) and percentage (%), mean, standard deviation, minimum, and maximum values. Whether the control and intervention groups exhibited a conjugate structure in terms of descriptive characteristics was checked with chi-square analysis for categorical variables and independent groups t-test for numerical variables.

Being tested
video training
Keywords
mother, education, video, diaper dermatitis, napkin dermatitis, diaper rash
Medical subject headings
Diaper Rash

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • video trainingOther

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

Study groups in NCT07205055
Study groupRoleWhat they receive
studyActive comparatorThe 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.
Receives: Other: video training
CONTROLNo interventionNO APPLICATION WILL BE MADE

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 7 days

Secondary outcomes (1)
  1. Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants

    The Uncomplicated Diaper Dermatitis Severity Assessment Scale (UCDDS) is a four-item scale developed by Buckley and colleagues in 2016. In the study in which the scale was developed, the Cronbach's alpha value was found to be 0.702 (Buckley et al., 2016). The Turkish adaptation of the scale was conducted by Keskin in 2019, and validity and reliability studies were also conducted. The Cronbach's alpha value was found to be 0.81 in the Turkish adaptation. The reliability coefficients of the items were reported as 0.73, 0.80, 0.78, and 0.79, respectively.

    Possible scores on the UCDDS range from 0 to 6. A higher total score indicates an increased severity of diaper dermatitis.

    Measured: 7 DAYS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2025
  2. Study start1 Jun 2025
  3. Primary completion15 Sep 2025
  4. Study completion18 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07205055
Sponsor's protocol ID
UU-SBF-GA-01
Status last verified
Sep 2025
First submitted
24 Sep 2025
Last updated
3 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: If anyone wants to do any meta-analysis after the study is published, they can contact me via email.

Questions about this trial

What is this clinical trial studying?

A study testing video training in people with Diaper Dermatitis and Diaper Rash, run by Uskudar University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mothers' Child Care Knowledge and Practice Level Form (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.

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