Trials / Completed
CompletedNCT07503457
The Effect of Using Coconut Oil and Moisturizing Lotion in Moisturizing the Skin of Premature Newborns on Skin Condition and Vital Signs
THE EFFECT OF USING COCONUT OIL AND MOISTURIZING LOTION IN MOISTURIZING THE SKIN OF PREMATURE NEWBORNS ON SKIN CONDITION AND VITAL SIGNS
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Bircan Kahraman Berberoglu · Academic / Other
- Sex
- All
- Age
- 32 Weeks – 37 Weeks
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This study is a randomized controlled trial design. The study will include three groups: two intervention groups and one control group. Infants meeting the inclusion criteria will be selected into the groups using a simple randomization method. This study will be conducted between September 16, 2024, and March 16, 2025 (6 months) with 32-37 week premature infants admitted to the Democracy University Buca Seyfi Demirsoy Training and Research Hospital ICU 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). Infants in the two intervention groups will have moisturizing lotion or coconut oil applied to their skin, while infants in the control group will receive skincare materials available in the ward routine. Portable devices will be used to measure the skin pH (Ph-Meter 98218) and moisture (Elitech GSP-6 Dual-Cable Temperature and Humidity Measurement Data Logger) of infants. These easy-to-use devices measure skin moisture and pH through contact. They have no harmful effects on the human body. Kolmogorov-Smirnov or Shapiro-Wilk normality tests will be used to determine whether the data conform to a normal distribution. Descriptive statistical analyses (number, percentage, mean, standard deviation, etc.), Chi-square test, Student-t test or Mann Whitney U test to compare the difference between two groups, one-way analysis of variance (ANOVA) or Kruskal Wallis H-test to compare the difference between three groups will be used. Pearson correlation analysis or Spearman correlation analysis will be performed to evaluate the relationship between continuous variables (Büyüköztürk, 2017). Values with p\<0.05 will be considered statistically significant.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | oil application | * The researcher will wash their hands again according to the hospital's procedure. * During the application, the baby will first be placed on its back, then on its side and stomach, and the body will be lubricated with coconut oil. * Coconut oil will be applied to the entire body surface except the hands, head, face, and genital area with light touches using the palm of the hand. The application will take approximately 8-10 minutes. The amount of oil to be used in each application will be approximately 3-4 ml/kg. |
Timeline
- Start date
- 2024-03-16
- Primary completion
- 2025-03-16
- Completion
- 2025-09-16
- First posted
- 2026-03-31
- Last updated
- 2026-03-31
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT07503457. Inclusion in this directory is not an endorsement.