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

Sponsor

Karadeniz Technical University (Other)

Overall Status

Completed

CT.gov ID

NCT06134505

Collaborator

(none)

Enrollment

Location

Arms

10.5

Actual Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Hypothesis 1 (H1): Restoderm barrier cream, consisting of propolis, royal jelly, perga and plant oil mixture used in the care of diaper dermatitis, is more effective in healing diaper dermatitis than the barrier cream containing 40% zinc oxide.

Hypothesis 2 (H2): Restoderm barrier cream, consisting of propolis, royal jelly, perga and plant oil mixture used in the care of diaper dermatitis, is more effective in healing diaper dermatitis than pure olive oil.

Hypothesis 3 (H3): Diaper Dermatitis Severity Assessment Scale scores are lower in babies who use Restoderm barrier cream, which consists of propolis, royal jelly, perga and plant oil mixture, in the care of diaper dermatitis, compared to babies who use barrier cream containing 40% zinc oxide.

Hypothesis 4 (H4): Diaper Dermatitis Severity Assessment Scale scores are lower in babies using Restoderm barrier cream, consisting of propolis, royal jelly, perga and plant oil mixture, in the care of diaper dermatitis, than babies using pure olive oil.

Condition or Disease	Intervention/Treatment	Phase
Diaper Dermatitis Healing	Procedure: Use of restoderm in the healing of diaper dermatitis Procedure: Use of sudocrem in the healing of diaper dermatitis Procedure: Use of olive oil in the healing of diaper dermatitis	N/A

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, royal jelly, perga 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 Form", 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

93 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 24, 2022

Actual Primary Completion Date :

Nov 8, 2023

Actual Study Completion Date :

Nov 8, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental: Experimental Group1 Restoderm group	Procedure: Use of restoderm in the healing of diaper dermatitis 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 restoderm cream 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: Experimental Group2 Olive oil group	Procedure: Use of olive oil in the healing of diaper dermatitis 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.
Active Comparator: Control Group Sudocrem group	Procedure: Use of sudocrem in the healing of diaper dermatitis 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 sudocrem 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.

Arm

Intervention/Treatment

Experimental: Experimental: Experimental Group1

Restoderm group

Procedure: Use of restoderm in the healing of diaper dermatitis

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 restoderm cream 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: Experimental Group2

Olive oil group

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

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.

Active Comparator: Control Group

Sudocrem group

Procedure: Use of sudocrem in the healing of diaper dermatitis

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 sudocrem 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.

Outcome Measures

Primary Outcome Measures

Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants [5 minutes]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 6 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Antalya Provincial Directorate of Health	Antalya	Kumluca/Antalya	Turkey	07000

Sponsors and Collaborators

Karadeniz Technical University

Investigators

Study Director: Ilknur Kahriman, Assoc. Prof., Karadeniz Technical University
Principal Investigator: Bahar Aksoy, MAster, Karadeniz Technical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

İlknur KAHRİMAN, Assoc. Prof, Karadeniz Technical University

ClinicalTrials.gov Identifier:

NCT06134505

Other Study ID Numbers:

İlknurKahriman

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by İlknur KAHRİMAN, Assoc. Prof, Karadeniz Technical University

Additional relevant MeSH terms:

Dermatitis

Diaper Rash

Study Results

No Results Posted as of Nov 18, 2023