Child
Conditions
Keywords
moisturizing lotion, coconut oil, Preterm
Brief 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 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.
Interventions
BEHAVIORALOil 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.
BEHAVIORALMoisturizing Lotion
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 moisturizing lotion. Moisturizing Lotion 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.
Sponsors
Bircan Kahraman Berberoglu
Aydin Adnan Menderes University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
32 Weeks to 37 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant Information and Monitoring Form (Appendix 1): | five days | The Infant Information Form is an 8-question form prepared by researchers using literature. The form includes information on the baby's demographic characteristics, gender, gestational age at birth and corrected gestational age, mode of delivery, birth weight, head circumference, medical diagnosis, and feeding type. Additionally, a table is included at the bottom of the form for recording the baby's body temperature, heart rate, oxygen saturation, skin moisture, and skin pH before and for 5 days after the procedure. |
| Neonatal Skin Status Assessment (Appendix 2): | five days | This scale, developed by Lund and Osborne (2004), is used to assess the skin status of healthy or sick preterm, term, and postterm newborns. The newborn's skin status is scored based on the presence of redness, dryness, and impaired skin integrity/peeling. It is developed as a three-point Likert scale, with each item/finding given a score from 1 to 3. The lowest possible score is 3, and the highest is 9. A total score higher than 3 indicates a risk of impaired skin integrity in the newborn, while a higher score indicates poor skin status. The reliability of the scale has been reported by researchers to be between 0.66 and 0.89. |
Countries
Turkey (Türkiye)
Outcome results
None listed