Comparison of Coconut and Sunflower Oil Application in Preserving Babies' Skin Integrity

NCT05266209 | Completed

• 1 other identifier: 0
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study was planned to examine the effects of coconut and sunflower oils applied to the skin of newborns on the daily fluid intake and output of the baby, the weight gain/decrease status and skin integrity.

Conditions

Skin Care

Keywords

Coconut oil; Sunflower oil; neonatal; Neonatal Intensive Care Unit; skin care

Outcome Measures

Primary Outcomes (2)

• effect on skin integrity

  Evaluation with Newborn Skin Condition Evaluation Form (NSCE) form: Evaluations will be made using the YCDD form 48-72 hours after each application (Monday, Thursday, Sunday). Skin condition scoring of the newborn; It is performed according to the presence of signs of redness, dryness and deterioration of skin integrity/peeling. It was developed in a three-point Likert format and each item/finding is given a score from 1 to 3. The lowest score that can be obtained as a result of the evaluation is 3, and the highest score is 9. A total score higher than 3 indicates that there is a risk of deterioration of the skin integrity of the newborn, while a high score indicates that the newborn's skin condition is poor.

  Evaluation with Newborn Skin Condition Evaluation Form (NSCE) form: Evaluations will be made using the YCDD form 48-72 hours after each application (Monday, Thursday, Sunday).

• the effect of the baby's weight gain/decrease on 7,14, 21, 28 days

  The baby's weight will be measured on days 7, 14, 21, 28, naked and without diapers.

  The scale is sensitive enough to measure in very small units.

Study Arms (3)

Experimental (coconut oil group)

EXPERIMENTAL

Before moistening, the skin of newborns is evaluated using the Newborn Skin Condition Evaluation Form form. Moisturizers are applied to the thorax, back, arms and legs by massage, respectively, and the skin is absorbed. If it is to be applied for the first time, it is applied to a small area of the body under the control of a doctor. If there is no reaction, it is applied by massaging other areas. Since the babies to be included in the sample group are borderline and moderately premature (34-37W), 3-4 ml/kg (coconut oil)moisturizer will be applied. Evaluation with NSCE form: Evaluations will be made using the NSCE form 48-72 hours after each application (Monday, Thursday, Sunday). Routine care will be applied to the skin of the newborns in the control group in the hospital. The control group will be evaluated using the NSCE form 3 days a week (Monday, Thursday, Sunday).

Other: Coconut oil skin care group

Experimental (sunflower oil group)

OTHER

Before moistening, the skin of newborns is evaluated using the Newborn Skin Condition Evaluation Form form. Moisturizers are applied to the thorax, back, arms and legs by massage, respectively, and the skin is absorbed. If it is to be applied for the first time, it is applied to a small area of the body under the control of a doctor. If there is no reaction, it is applied by massaging other areas. Since the babies to be included in the sample group are borderline and moderately premature (34-37W), 3-4 ml/kg (sunflower oil) moisturizer will be applied. Evaluation with NSCE form: Evaluations will be made using the NSCE form 48-72 hours after each application (Monday, Thursday, Sunday).

Other: Coconut oil skin care group

No Intervention (Control group)

NO INTERVENTION

Before moistening, the skin of newborns is evaluated using the Newborn Skin Condition Evaluation Form form. Routine maintenance of the intensive care unit will be implemented. Evaluation with NSCE form: Evaluations will be made using the NSCE form 48-72 hours after each application (Monday, Thursday, Sunday). Routine care will be applied to the skin of the newborns in the control group in the hospital. The control group will be evaluated using the NSCE form 3 days a week (Monday, Thursday, Sunday)

Interventions

Coconut oil skin care group OTHER

No special technique was used for sample selection, random sample selection will be made. In the evaluation made according to the large effect size, the number of samples determined for Power: 0.80, :0.20 and :0.05 was determined as 66, with a minimum of 22 for each group. Calculations were made in computer environment using Power analysis (G\*Power 3.1.9.2) program. Random selection method will be used while creating research groups. Coconut oil, sunflower oil and control groups will be formed according to the order of admission to the unit. E.g; Coconut oil is planned for the first hospitalized newborn, sunflower oil for the second newborn, and third hospitalized newborn control group. This order will be repeated until a sufficient number of cases is reached when the newborns are included in the groups.

Also known as: sunflower oil skin care group

Experimental (coconut oil group); Experimental (sunflower oil group)

Eligibility Criteria

• Age: 34 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Voluntary verbal and written consent of the parents of the newborn,
• The gestational week of the newborn is 34 and above,
• The birth weight of the newborn is 2000 g and above,
• The hospitalization of the newborn is the first day of birth.

You may not qualify if:

• Unstable clinical condition and vital signs,
• Having a major congenital anomaly,
• High risk of infection due to surgery,
• More than 5% of the body surface is a skin disease,
• External application of medication to the skin in its treatment.

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Sakarya Education and Training Hospital

Sakarya, Adapazarı, 54050, Turkey (Türkiye)

Location

Study Officials

• NURSAN ÇINAR, Prof

  Sakarya University

  PRINCIPAL INVESTIGATOR

• HAMİDE ZENGİN, Asis Prof

  Bilecik Seyh Edebali Universitesi

  PRINCIPAL INVESTIGATOR

• İBRAHİM CANER, Prof

  Sakarya University

  PRINCIPAL INVESTIGATOR

• ERTUĞRUL GÜÇLÜ, Prof

  Sakarya University

  PRINCIPAL INVESTIGATOR

• ÖZNUR TİRYAKİ, PhD

  Sakarya Education and Research Hospital

  PRINCIPAL INVESTIGATOR

• MELTEM KARABAY, Asis Prof

  Sakarya University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The researcher is not blind since the group of infants will be assigned by the researcher in order. The statistician was also blinded for the data analysis purpose.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: March 4, 2022
• Study Start: March 25, 2022
• Primary Completion: February 25, 2023
• Study Completion: May 12, 2023
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)