The Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates

Not Applicable

Recruiting

• Conditions: Skin Care
• Interventions: Other: Plant (natural) oils

• Registration Number: NCT06286813
• Lead Sponsor: Marmara University

Brief Summary

This study aimed to evaluate the effects of extra virgin olive and almond oils on maintaining skin integrity in neonates admitted to the neonatal intensive care unit.

Interventional research with two parallel groups and no control group

Detailed Description

The study was conducted in the Neonatal intensive care unit (NICU) of a training and research hospital.The total number of infants admitted to the NICU was 28. Each nurse is responsible for the care of 3 or 4 newborn babies.

Skin are routines in the NICU: A skin condition assessment score is routinely performed every day (09.00 am) in all infants and moisturizing products are used for their skin care. Therefore, there was no control group in the study.

Extra virgin olive oil and almond oil are among the skin care products used in the clinic routines. Therefore, the effects of the currently used oils were compared in the study

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-09
• Study First Submitted QC: 2024-02-22
• Last Update Submitted: 2024-02-22
• Study First Posted: 2024-02-29
• Last Update Posted: 2024-02-29
• Study Start: 2024-03-02
• Primary Completion: 2024-05-03
• Study Completion: 2024-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Neonates who were born at 37-42 weeks of gestation, were planned to be hospitalized in the NICU for at least 5 days, had a post-natal age of 0-72 hours, and were received written and verbal consent from parents were included in the study.

Read More

Exclusion Criteria

• ; Neonates who were discharged before 5 days and required phototherapy were excluded from the study.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Almond oil group	Plant (natural) oils	On the first day of neonates' admission to the clinic, their skin condition will be evaluated using the NSCS, and the hydration of skin will be measured using a digital moisture meter with the recommended usage guide. During morning care at 09:00 a.m., almond oil (10 ml) will be applied to their entire body, except for the head. Three hours after the application, at 12:00 a.m., their skin condition will be assessed, and the hydration will be measured and recorded. This application will continue for 5 days.
Extra Virgin Olive Oil Group	Plant (natural) oils	On the first day of neonates' admission to the clinic, their skin condition will be evaluated using the NSCS, and the hydration of skin will be measured using a digital moisture meter with the recommended usage guide. During morning care at 09:00 a.m., extra virgin olive oil(10 ml) will be applied to their entire body, except for the head. Three hours after the application, at 12:00 a.m., their skin condition will be assessed, and the hydration will be measured and recorded. This application will continue for 5 days.

Primary Outcome Measures

Name	Time	Method
Neonatal skin condition score	5 days	This is a three-point Likert-type scale to evaluate dryness, redness, peeling / deterioration in newborn baby skin. For each criterion in the evaluation of the scale score; 1 refers to the best and 3 to the worst skin condition. The highest and lowest scores on the scale are 9 and 3, respectively. A higher scale score indicates poorer skin condition
Skin moisture meter(DMM):	5 days	The product shows the moisture level (0%-99.9%) in contact with the skin and does not harm the skin. It provides measurement results with high precision

Trial Locations

Locations (1)

Bakırköy Dr. Sadi Konuk Training and Research Hospital; 🇹🇷 Istanbul, Turkey