The Effect of Using Coconut Oil and Moisturizing Lotion in Moisturizing the Skin of Premature Newborns

Bircan Kahraman Berberoglu

Status: Completed

Conditions: Child

Treatments: Behavioral: Moisturizing Lotion; Behavioral: Oil Application

Study type: Interventional

Funder types: Other

Identifiers

NCT07503457

Aydın Adnan Menderes Uni

Details and patient eligibility

About

Hypothesis H01: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on skin condition assessment scores.

Hypothesis H02: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on pH values.

Hypothesis H03: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on skin moisture levels.

Hypothesis H04: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on body temperature values.

Hypothesis H05: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on pulse values. Hypothesis H06: Using coconut oil and moisturizing lotion to moisturize the skin of preterm infants has no effect on saturation values.

Full description

This study is designed as a randomized controlled trial. The study will include three groups: two intervention groups and one control group. Infants meeting the inclusion criteria will be allocated to the groups using a simple randomization method. The study will be conducted between September 16, 2024, and March 16, 2025 (6 months) with 32-37-week premature infants admitted to the Intensive Care Unit of Democracy University Buca Seyfi Demirsoy Training and Research Hospital in Izmir.

There are three groups: Study Group 1 (moisturizing lotion [Muslera®]) (n=30), Study Group 2 (coconut oil) (n=30), and Control Group (n=30). In the intervention groups, moisturizing lotion or coconut oil will be applied to the infants' skin, whereas infants in the control group will receive routine skincare provided in the ward.

Portable devices will be used to measure skin pH (Ph-Meter 98218) and moisture (Elitech GSP-6 Dual-Cable Temperature and Humidity Measurement Data Logger). These devices measure skin moisture and pH through contact and have no harmful effects on the human body.

Kolmogorov-Smirnov or Shapiro-Wilk tests will be used to assess the normality of the data. Descriptive statistical analyses (number, percentage, mean, standard deviation, etc.), chi-square test, Student's t-test or Mann-Whitney U test for comparisons between two groups, and one-way analysis of variance (ANOVA) or Kruskal-Wallis H test for comparisons among three groups will be used. Pearson or Spearman correlation analyses will be conducted to evaluate the relationships between continuous variables (Büyüköztürk, 2017). A p-value of <0.05 will be considered statistically significant.

Enrollment: 90 patients

Sex: All

Ages: 32 to 37 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Inclusion criteria:

• Babies with a gestational age between 320/7 and 376/7 weeks,
• Babies with a birth weight of 1500 grams or more will be included.

Exclusion Criteria: Infants who: • are receiving invasive or non-invasive mechanical ventilation support,

• are receiving oxygen support at a concentration greater than 23-25% in the incubator,
• have a major congenital anomaly on the skin surface,
• have a high infection or risk of infection due to surgery,
• have a congenital anomaly,
• have a skin disease/problem covering more than 5% of their body surface will not be included.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

90 participants in 2 patient groups

Moisturizing Lotion

Experimental group

Description:

* Intervention Group 1 (Moisturizing Lotion) * The application and data collection will be carried out by Nurse Zehra SÖZKESEN, who works in the neonatal intensive care unit where the research will be conducted. The research will last 5 days for each baby. Measurements will be taken before and after the application (15 minutes after application). * Before the application, the parent will be consulted and an "Informed Consent Form" will be completed. * Applications will be performed in a way that does not disrupt the ward routine and will be carried out after daily care during routine care hours, between 09:00-10:00 in the morning. * The lotion to be used for babies included in the moisturizing lotion group will be kept at the patient's bedside with a barcode label attached to each patient, and a separate sterile container of lotion will be used for each patient. * Before the application, the researcher will wash their hands according to the hospital's procedur

Treatment:

Behavioral: Moisturizing Lotion

Coconut Oil Group

Experimental group

Description:

Intervention Group 2 (Coconut Oil Group) * The application and data collection will be carried out by Nurse Zehra SÖZKESEN, who works in the neonatal intensive care unit where the research will be conducted. The research will last 5 days for each baby. Measurements will be taken before and after the application (15 minutes after the application). * Before the application, the parent will be consulted and an "Informed Consent Form" will be completed. * Applications will be performed in a way that does not disrupt the ward routine and will be carried out after daily care between 09:00-10:00 in the morning, which are routine care hours. * The oil to be used for babies included in the coconut oil group will be kept at the patient's bedside with a barcode label attached to each patient and will be used in a separate sterile container for each patient. * Before the application, the researcher will wash their hands according to the hospital's procedure.

Treatment:

Behavioral: Oil Application