Clinical trial NCT06134505: Evaluation of the Efficiency of Local Application of Bee Products in the Care of Diaper Dermatitis in Infants
Official title: Evaluation of the Efficiency of Local Application of Bee Products in the Care of Diaper Dermatitis in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaper Dermatitis Healing
Keywords: diaper dermatitis
healing
bee products
care
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 93
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the local application of bee products in the care of diaper dermatitis in infants.

1. H1: Barrier cream 1, consisting of a mixture of propolis, beeswax, queen bee larva and plants oil used in the care of diaper dermatitis, is more effective in recovering diaper dermatitis than barrier cream 2 containing zinc oxide.
2. H2: Barrier cream 1, consisting of a mixture of propolis, beeswax, queen bee larva and plants oil used in the care of diaper dermatitis, is more effective in recovering diaper dermatitis than olive oil.
3. H3: Diaper Dermatitis Severity Assessment Scale scores are lower in babies who use barrier cream 1, which consists of a mixture of propolis, beeswax, queen bee larva and plants oil, in the care of diaper dermatitis, compared to babies who use barrier cream 2, which contains zinc oxide.
4. H4: Diaper Dermatitis Severity Assessment Scale scores are lower in babies who use barrier cream 1, which consists of a mixture of propolis, beeswax, queen bee larva and plants oil, in the care of diaper dermatitis, than babies who use olive oil.

Detailed description: Diaper dermatitis is one of the most common dermatological problems of infancy. Diaper dermatitis constitute from approximately 25% of visits to primary health care services for dermatological complaints in the first year of life. The ABCDE rule is based on the prevention of diaper dermatitis. According to ABCDE rule; airing the bottom of babies with diaper dermatitis, changing diapers hourly in the newborn period, every 3-4 hours in infancy, cleaning using warm water or wet wipes sucked with water, applying barrier creams in a thin layer after cleaning the area, and protecting from diaper dermatitis and providing diaper hygiene. Families should be educated on the right skin care practices. This thesis study was conducted in a randomized control experimental design in order to investigate the effect of olive oil, 40% zinc oxide, propolis, royal jelly, perga and plant oil mixture on the healing process in the care of 1-6 months old infants with first degree diaper dermatitis who applied to the Family Health Center/ Child Outpatient Clinic. The population of the study will be 1-6 month old babies with first degree diaper dermatitis who are registered to Family Health Centers in Antalya's Kumluca district and applied to the pediatric outpatient clinic of Kumluca State Hospital. The sample of the study was consisted of 93 infants (Olive oil: 31, propolis, beeswax, queen bee larva and plant oil mixture: 31, 40% zinc oxide cream: 31) registered to the Family Health Center and and applied to Kumluca State Hospital between January 2022 and December 2023, aged 1-6 months and meeting the sample selection criteria. The data were collected using the "Parent-Infant Descriptive Information Form", "Observation Forms", and "Assessing the Severity of Uncomplicated Diaper Dermatitis" in Infants Scale in Infants, after obtaining the permission of the ethics committee and institution of the research. The data was evaluated using the SPSS 23 package program.

Eligibility criteria: Inclusion Criteria:

* Infants aged 1-6 months registered at Family Health Centers No. 1, No. 2 and No. 3,
* Infants aged 1-6 months admitted to Kumluca State Hospital's Pediatric Outpatient Clinic,
* Infants with grade one diaper dermatitis according to the Uncomplicated Diaper Dermatitis in Infants Severity Rating Scale,
* Breastfed babies,
* Babies without antibiotics,
* Families who do not regularly use protective barrier cream/oil for diaper dermatitis care,
* Babies who have not started supplementary food,
* Babies with no other dermatologic or allergic skin conditions,
* Families who agreed to participate in the study were included.

Exclusion Criteria:

* Babies who are not registered to the Family Health Centers where the research was conducted,
* Newborns and babies older than 6 months who apply to the Pediatric Outpatient Clinic of Kumluca State Hospital,
* Babies who do not have first degree diaper dermatitis according to the Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants,
* Babies fed with breast milk + formula or only formula,
* Babies using antibiotics,
* Families who regularly use protective barrier cream/oil in diaper dermatitis care,
* Babies who switch to solid food,
* Babies with dermatological or other allergic skin problems,
* Babies using antimycotic drugs (Ampotericin etc.),
* Babies who use a bladder for a long time,
* Babies with urinary incontinence due to diseases such as meningomyolocele and cerebral palsy,
* Families who did not agree to participate in the research were not included.

Primary outcomes:
measure: Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Provincial Directorate of Health
state: Kumluca/Antalya
Study officials:
affiliation: Karadeniz Technical University
name: Ilknur Kahriman, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: Karadeniz Technical University
name: Bahar Aksoy, MAster
role: PRINCIPAL_INVESTIGATOR
References: