Evaluation of the Efficiency of Local Application of Bee Products in the Care of Diaper Dermatitis in Infants

NCT06134505 | Completed

• 1 other identifier: İlknurKahriman
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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. 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. 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. 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. 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.

Conditions

Diaper Dermatitis Healing

Keywords

diaper dermatitis; healing; bee products; care

Outcome Measures

Primary Outcomes (1)

• Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants

  The score to be received from each item of the scale varies between "0-6". The highest and lowest scores that can be obtained from the items are 0-3 points in the "Severity of Erythema or Irritation" item, 0-1 point in the "Extent of Diaper Dermatitis" item, 0-1 point in the "Papules and Pustules" item, and 0-1 point in the "Light Skin" item. It is between 0-1 points. Low total scores from the scale indicate that the severity of diaper dermatitis is low, and high scores indicate that the severity of diaper dermatitis is high.

  5 minutes

Study Arms (3)

Experimental: Experimental Group1

EXPERIMENTAL

Barrier cream group 1 consists of a mixture of propolis, beeswax, queen bee larva and plant oil

Procedure: Use of Barrier cream group 1 in the healing of diaper dermatitis

Experimental: Experimental Group2

EXPERIMENTAL

Olive oil group

Procedure: Use of olive oil in the healing of diaper dermatitis

Control Group

ACTIVE COMPARATOR

Barrier cream group 2 consists of zinc oxide

Procedure: Use of Barrier cream 2 in the healing of diaper dermatitis

Interventions

Use of Barrier cream group 1 in the healing of diaper dermatitis PROCEDURE

In this study, the infant's first-degree diaper dermatitis was determined by the doctor or midwife using the Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants. After first-degree diaper dermatitis was detected in the babies and their written consent was obtained, the parents of the babies were informed about the research before application and the parent-baby identification information form was filled out. Families were provided with education based on the ABCDE model. Mothers were informed that Barrier cream 1 would be used at each diaper change. Baby dermatitis was monitored face to face by the researcher on the 1st, 3rd and 5th days, and the scores were recorded on the observation form. Follow-up of those with a diaper dermatitis score of "0" was discontinued because full recovery was achieved.

Experimental: Experimental Group1

Use of Barrier cream 2 in the healing of diaper dermatitis PROCEDURE

In this study, the infant's first-degree diaper dermatitis was determined by the doctor or midwife using the Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants. After first-degree diaper dermatitis was detected in the babies and their written consent was obtained, the parents of the babies were informed about the research before application and the parent-baby identification information form was filled out. Families were provided with education based on the ABCDE model. Mothers were informed that barrier cream 2 would be used at each diaper change. Baby dermatitis was monitored face to face by the researcher on the 1st, 3rd and 5th days, and the scores were recorded on the observation form. Follow-up of those with a diaper dermatitis score of "0" was discontinued because full recovery was achieved.

Control Group

Use of olive oil in the healing of diaper dermatitis PROCEDURE

In this study, the infant's first-degree diaper dermatitis was determined by the doctor or midwife using the Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants. After first-degree diaper dermatitis was detected in the babies and their written consent was obtained, the parents of the babies were informed about the research before application and the parent-baby identification information form was filled out. Families were provided with education based on the ABCDE model. Mothers were informed that olive oil would be used at each diaper change. Baby dermatitis was monitored face to face by the researcher on the 1st, 3rd and 5th days, and the scores were recorded on the observation form. Follow-up of those with a diaper dermatitis score of "0" was discontinued because full recovery was achieved.

Experimental: Experimental Group2

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Antalya Provincial Directorate of Health

Antalya, Kumluca/Antalya, 07000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diaper Rash

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Ilknur Kahriman, Assoc. Prof.

  Karadeniz Technical University

  STUDY DIRECTOR

• Bahar Aksoy, MAster

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 18, 2023
• Study Start: December 24, 2022
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 12 months after publication
• Access Criteria: Relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

TU (1)