Clinical trial NCT06800352: The Effect of Olive Oil and Centaury Oil on Rash
Official title: Investigation of the Effect of Olive Oil and Centaury Oil in the Management of Diaper Dermatitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diaper Dermatitis
Keywords: olive oil
centaury oil
diaper dermatitis
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block randomisation method will be used in this study. Using the online programme (http://www.randomizer.org), a random list of sets assigning infants to groups will be created. The infants who will constitute the sample of the study will be divided into 20 sets with 3 people in each set and sets will be formed by assigning numbers from 1 to 3 to each set. When the sets are obtained, the numbers from 1 to 3 will be written on small papers and group assignments will be made by lot method. In this way, the number of babies included in the groups and the probability of each baby to be included in the study groups will be equalised.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Diaper dermatitis is a preventable health problem. No study evaluating the efficacy of centaury oil in diaper dermatitis was found in the literature. This study will be conducted to investigate the effect of olive oil and centaury oil in the management of diaper dermatitis.

Detailed description: Diaper dermatitis is estimated to have an incidence of between 7% and 35%, although the prevalence cannot be determined precisely because it is not usually seen as a disease by parents and most patients are treated at home. Prevention of diaper dermatitis should be the main approach in treatment and care. Once it occurs, the aim of treatment is to accelerate the healing of the damaged area and prevent its spread. In the prevention and treatment of diaper dermatitis, practices such as ventilating the baby's diaper, changing the diaper frequently, keeping the area dry, cleaning with appropriate methods, using barrier creams and not tying the diaper tightly have been reported to be beneficial.

In the literature, studies using methods such as water, herbal cream (chamomile cream, calendula cream, aloe vera cream), barrier cream (zinc oxide) and herbal mixture (honey, beeswax, olive oil) were found in the treatment of infants with mild to moderate diaper dermatitis. It has been stated that the rates of diaper dermatitis will continue to increase if parents are not given adequate information about appropriate care and which products are beneficial or even harmful. In conclusion, diaper dermatitis is a preventable health problem. No study evaluating the efficacy of olive oil and centaury oil in diaper dermatitis was found in the literature. This study will be conducted to examine the effect of olive oil and centaury oil in the management of diaper dermatitis.

Eligibility criteria: Inclusion Criteria:

* The baby has mild diaper dermatitis according to the diaper dermatitis severity rating scale
* The baby receives antibiotic treatment
* The baby gets additional food
* The baby is between 6-18 months

Exclusion Criteria:

* Infants with moderate or severe diaper dermatitis according to the diaper dermatitis severity rating scale
* Babies with open wounds on the perineum,
* Babies with any skin disease
* Babies who use barrier creams or special oils in routine care

Primary outcomes:
measure: Outcome Measures
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Mardin
country: Turkey
facility: Mardin Training and Research Hospital
Study officials:
affiliation: Harran University
name: H YAĞMUR SEVİNÇ AKIN, Assistant Professor
role: STUDY_DIRECTOR
affiliation: Adiyaman University
name: MAKSUDE YILDIRIM, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Mardin Training and Research Hospital
name: BARIŞ AKIN, Specialist nurse
role: PRINCIPAL_INVESTIGATOR
affiliation: Celal Bayar University
name: NESRİN ŞEN CELASİN, Assoc. Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Inonu University
name: ZÜLEYHA GÜRDAP, RESEARCH ASSISTANT
role: PRINCIPAL_INVESTIGATOR
References: