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

NCT ID: NCT06286813

Last Updated: 2024-02-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-02

Study Completion Date

2024-05-30

Brief Summary

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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

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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

Conditions

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Skin Care

Keywords

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Newborn, skin care, extra virgin olive oil, almond oil.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional research with two parallel groups (almond olive group and virgin olive oil group) and no control group.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Almond oil group

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.

Group Type EXPERIMENTAL

Plant (natural) oils

Intervention Type OTHER

Using 10 ml of plant(natural) oil once a day for daily skin care of newborns

Extra Virgin Olive Oil Group

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.

Group Type EXPERIMENTAL

Plant (natural) oils

Intervention Type OTHER

Using 10 ml of plant(natural) oil once a day for daily skin care of newborns

Interventions

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Plant (natural) oils

Using 10 ml of plant(natural) oil once a day for daily skin care of newborns

Intervention Type OTHER

Eligibility Criteria

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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.

Exclusion Criteria

* ; Neonates who were discharged before 5 days and required phototherapy were excluded from the study.
Minimum Eligible Age

1 Hour

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AYŞE KARAKOÇ

Role: STUDY_DIRECTOR

Marmara University

Locations

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Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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AYŞE KARAKOÇ

Role: CONTACT

Phone: +905335695138

Email: [email protected]

Facility Contacts

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AYŞE KARAKOÇ

Role: primary

References

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Topcuoglu Arslan IZ, Karakoc A. Effect of Almond and Extra Virgin Olive Oils on Maintaining Skin Integrity in Neonates Admitted to the Neonatal Intensive Care Unit. Adv Skin Wound Care. 2025 Aug 1;38(7):381-386. doi: 10.1097/ASW.0000000000000306. Epub 2025 Apr 4.

Reference Type DERIVED
PMID: 40184517 (View on PubMed)

Other Identifiers

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Akarakoc

Identifier Type: -

Identifier Source: org_study_id