The Effect of Olive Oil and Centaury Oil on Rash

NCT06800352 | Completed

• 1 other identifier: HRU-VSYO-HYSA-2024/139
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaper Dermatitis

Keywords

olive oil; centaury oil; diaper dermatitis

Outcome Measures

Primary Outcomes (1)

• Outcome Measures

  The outcome measures for the sociodemographic data of the study will be collected by using the 'Introductory Information Form', which includes questions about the infant's identifying characteristics such as gender, age, height, weight and diaper care. The other outcome measure to be used in the study is the 'Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants' which will be used to rate the severity of diaper dermatitis in infants. Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants: The lowest score that can be obtained from the scale consisting of a total of four items is zero and the highest score is six. The minimum and maximum scores that can be obtained from each item are 0-3 points for the severity of erythema or irritation item, 0-1 point for the degree of diaper dermatitis item, 0-1 point for the papules and pustules item and 0-1 point for the open skin item. As the score on the scale increases, the degree of diaper dermatitis also increases

  1 year

Study Arms (2)

Olive Oil Application

EXPERIMENTAL

The degree of diaper dermatitis will be evaluated before and after the procedure (72 hours after the first procedure) using the 'Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants'. After cleaning the perineum as described to the mothers, they will be asked to apply olive oil to the perineum four times a day, 1 cc each time.

Other: Control

Centaury Oil Application

EXPERIMENTAL

The degree of diaper dermatitis of the infants will be evaluated before and after the procedure (72 hours after the first procedure) using the 'Uncomplicated Diaper Dermatitis Severity Rating Scale in Infants'. After cleaning the perineum as described to the mothers, they will be asked to apply centaury oil to the perineum four times a day, 1 cc each time.

Other: Control

Interventions

Control OTHER

The degree of diaper dermatitis of the babies will be evaluated before and after the procedure (72 hours after the first procedure) by using the 'Uncomplicated Diaper Dermatitis Severity Rating Scale in Babies (UNDDCS)'. Mothers will be asked to diaper their babies with cotton wool soaked with clear water.

Centaury Oil Application; Olive Oil Application

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Mardin Training and Research Hospital

Mardin, 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

• H YAĞMUR SEVİNÇ AKIN, Assistant Professor

  Harran University

  STUDY DIRECTOR

• MAKSUDE YILDIRIM, Assistant Professor

  Adiyaman University

  PRINCIPAL INVESTIGATOR

• BARIŞ AKIN, Specialist nurse

  Mardin Training and Research Hospital

  PRINCIPAL INVESTIGATOR

• NESRİN ŞEN CELASİN, Assoc. Professor

  Celal Bayar University

  PRINCIPAL INVESTIGATOR

• ZÜLEYHA GÜRDAP, RESEARCH ASSISTANT

  Inonu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 30, 2025
• Study Start: December 30, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)