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The Effect Of Olive Oil on Diaper Rash

Primary Purpose

Diaper Rash, Olive Oil

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Olive oil
Sponsored by
Karamanoğlu Mehmetbey University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diaper Rash

Eligibility Criteria

0 Months - 24 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Having a first-degree diaper rash
  • Being 0-24 months old
  • Having the family's consent indicating that they allow their child to be included in the study

Exclusion Criteria:

  • The baby's having anorectal congenital anomaly
  • The baby's having an obstacle to the application of olive oil (allergy, etc.)
  • Having a second-degree or third-degree rash

Sites / Locations

  • Karamanoglu Mehmetbey University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Olive oil

Routine care

Arm Description

Outcomes

Primary Outcome Measures

Comparison of the scores obtained from the Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants by the Experimental and Control Groups.
comparison of the scores obtained from the Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants by the Experimental and Control Groups

Secondary Outcome Measures

Full Information

First Posted
March 30, 2022
Last Updated
April 6, 2022
Sponsor
Karamanoğlu Mehmetbey University
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1. Study Identification

Unique Protocol Identification Number
NCT05328232
Brief Title
The Effect Of Olive Oil on Diaper Rash
Official Title
Effects of Olive Oil Use on The Healing of Diaper Rash
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
November 1, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karamanoğlu Mehmetbey University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective: Diaper rash is an irritating, common skin problem in newborns and young children and occurs in the skin rubbed by wet diapers and in the armpits due to heat, moisture and irritation. This experimental study was planned to investigate the effect of olive oil use on the healing of diaper rash in infants with first-degree diaper rash undergoing treatment in an infant ward. Methods: The study conducted between September 2020 and December 2020 included 37 infants aged 0-24 months who were treated for any reason in the Infant Clinic of a medical school and had first-degree rash. The infants in the experimental and control groups were "treated with olive oil and X brand cream" respectively. The X brand cream and the effects of olive oil and X brand cream use on the improvement of diaper rash were compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaper Rash, Olive Oil

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Olive oil
Arm Type
Experimental
Arm Title
Routine care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Olive oil
Intervention Description
The parents of the babies included in the experimental group were asked to fill in the questionnaires. The infant's skin condition was assessed using the Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants. Each time the diaper was changed, the diaper area was cleaned with water and cotton wool and dried, 1-2 cc of natural extra virgin olive oil was applied, and the new diaper was fastened. At the end of each day, the diaper area was evaluated by the researcher and a nurse by using the Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants.
Primary Outcome Measure Information:
Title
Comparison of the scores obtained from the Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants by the Experimental and Control Groups.
Description
comparison of the scores obtained from the Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants by the Experimental and Control Groups
Time Frame
October-November 2020 (two months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Having a first-degree diaper rash Being 0-24 months old Having the family's consent indicating that they allow their child to be included in the study Exclusion Criteria: The baby's having anorectal congenital anomaly The baby's having an obstacle to the application of olive oil (allergy, etc.) Having a second-degree or third-degree rash
Facility Information:
Facility Name
Karamanoglu Mehmetbey University
City
Karaman
State/Province
Central
ZIP/Postal Code
70100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
Citation
Adalat S, Wall D, Goodyear H. Diaper dermatitis-frequency and contributory factors in hospital attending children. Pediatr Dermatol. 2007 Sep-Oct;24(5):483-8. doi: 10.1111/j.1525-1470.2007.00499.x. PMID: 17958792. 2. Atherton DJ. The Aetiology and Management of Irritan Diaper Dermatitis. European Academy of Dermatology and Venereology, 2001;15:1-4. 3. Al-Waili N.S. Clinical and Mycological Benefits of Topical Application of Honey, Olive oil and Beeswax in Diaper Dermatitis. Clinical Microbiology and Infection, 2005;11(2): 141-163. 4. Arısoy A, Canbulat N, Ayhan A. Karaman İlindeki Annelerin Bebeklerinin Bakımında Uyguladıkları Geleneksel Yöntemler. Anadolu Hemşirelik ve Sağlık Bilimleri Dergisi, 2014;17(1): 23-32. 5. Buckley BS, Mantaring JB, Dofitas RB, Lapitan MC, Monteagudo A. A New Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants, Development and Validation. Pediatric Dermatology, 2016,33(6):632-639. 6. Danby SG, Alenezi T, Sultan A, Lavender T, Chittock J, Brown K, Cork MJ. Effect of Olive and Sunflower Seed Oil on the Adult Skin Barrier, İmplications for Neonatal Skin Care. Pediatric Dermatology, 2013;30(1):42-50. 7. Duffy LJ, Ferguson MR, Darmstadt LG. Opportunities for Improving, Adapting and Introducing Emollient Therapy and Improved Newborn Skin Care Practices in Africa. Journal of Tropical Pediatrics. 2012;58(2): 88-95. 8. Felter SP, Carr AN, Zhu T, Kirsch T, Niu G. Safety Evaluation for İngredients Used in Baby Care Products: Consideration of Diaper Rash. Regulatory Toxicology and Pharmacology, 2017;90:214-221. 9. Fölster-Holst R. Differential Diagnoses of Diaper Dermatitis. Pediatric Dermatology, 2018;35:10-18. 10. Gözen D, Çağlar S, Bayraktar S, Atıcı F. Diaper Dermatitis Care of Newborns Human Breast Milk or Barrier Cream. Journal of Clinical Nursing, 2013;23(3-4):515-523. 11. Gupta AK, Skinner AR. Management of Diaper Dermatitis. Int J Dermatol, 2004;43: 830-834. 12. Kenner C, Lott JW, Flandermeyer A. A Comprehensive Neonatal Nursing. WB Saunders, Philadelphia, 1998;2:67-58. 13. Keskin E. Bebeklerde Komplike Olmayan Bez Dermatiti Şiddet Değerlendirme Ölçeğinin Geçerlik ve Güvenirliğinin İncelenmesi. Yüksek Lisans Tezi, Ege Üniversitesi Sağlık Bilimleri Enstitüsü, 2019, İzmir. 14. Kohlendorfer-Kiechl U, Berger C. Inzinger R. The Effect of Daily Treatment with an Olive Oil/Lanolin Emollient on Skin Integrity in Preterm Infants: A Randomized Controlled Trial. Pediatric Dermatology. 2008;25(2): 174178. 15. Kirlek F. Erken Pospartum Dönemde Meme Başı Ağrısı ve Çatlaklarının Önlenmesinde Anne Sütü ve Zeytinyağının Etkisi. Yüksek Lisans Tezi, Adnan Menderes Üniversitesi Sağlık Bilimleri Enstitüsü, 2010, Aydın. 16. Lupiáñez-Pérez I, Morilla-Herrera JC, Ginel-Mendoza L, Martín-Santos FJ, Navarro-Moya FJ, Sepúlveda-Guerra RP, Morales-Asencio JM. Effectiveness of Olive Oil for the Prevention of Pressure Ulcers Caused in İmmobilized Patients Within the Scope of Primary Health Care, Study Protocol for A Randomized Controlled Trial. Trials, 2013;14(1):1-7. 17. Mandleco BL. Theoretical Approaches to the Growth and Development of Children. In Pediatric Nursing Caring for Children and Their Families. (Eds). Micki L. Potts. United States of America. Delmar Thomsan Learning. 2002. 18. Nield LS, Kamat D. Prevention, Diagnosis and Management of Diaper Dermatitis. Clin Pediatr, 2007;46:480-486. 19. Önder M, Adışen E, Velagiç Z. Diaper Dermatit. Çocuk Sağlığı ve Hastalıkları Dergisi, 2007;50:129-135. 20. Panahi Y, Sharif MR, Sharif A, Beiraghdar F, Zahiri Z, Amirchoopani G, Sahebkar A. A Randomized Comparative Trial on the Therapeutic Efficacy of Topical Aloe Vera and Calendula Officinalis on Diaper Dermatitis in Children. The Scientific World Journal, 2012;20(12):1-5. 21. Pingvini S, Shahsavari S, Gazerani F, Abdolkavand S. Topical Use of Human Breast Milk for Diaper Rash in İnfants. Middle East Journal of Nursing, 2009;3:27-30. 22. Prasad HRY, Srivastava P, Verma KK. Diaper Dermatitis an Overview. The Indian Journal of Pediatrics, 2003;70(8):635-637. 23. Salam AR, Das KJ, Darmstadt LG, Bhutta AZ. Emollient Therapy for Preterm Newborn Infants-Evidence From the Developing World. BMC Public Health. 2013;13(3): 31-37. 24. Scheinfeld N. Diaper dermatitis. American journal of clinical dermatology, 2005;6(5): 273-281. 25. Sharifi-Heris Z, Amiri-Farahani L, Haghani H, Abdoli-Oskouee S, Hasanpoor-Azghady S. Comparison the Effects of Topical Application of Olive and Calendula Ointments on Children's Diaper Dermatitis. A Triple-blind Randomized Clinical Trial. Wiley Dermatology Therap, 2018;10(11):1-7. 26. Šikić Pogačar M, Maver U, Marčun Varda N, Mičetić-Turk D. Diagnosis and Management of Diaper Dermatitis in İnfants with Emphasis on Skin Microbiota in the Diaper Area. International Journal of Dermatology, 2018;57(3):265-275.
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The Effect Of Olive Oil on Diaper Rash

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