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

NCT ID: NCT05266209

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-25
• Study Completion Date: 2023-05-12

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.

Detailed Description

Although there is no consensus on the use of products in daily skin care to maintain the skin integrity of newborns, many products are used. These products; mustard, sunflower, sesame, coconut, olive, soybean, palm oils, ointment (Auqophor), cream (Eucerin) and moisturizers. It is stated that these products prevent skin drying and fissures, maintain skin integrity, and reduce transepidermal fluid loss (Vaseline).

Sunflower oil accelerates the maturation of the skin barrier, there is less weight loss in newborns younger than 35 weeks of gestation who are massaged with sunflower oil compared to the control group, the incidence of nosocomial infections in newborns who receive skin care with sunflower oil is lower than the control group, sunflower oil protects the newborn from infections, olive oil, more effective than oils such as soybean oil and mustard oil; In another study, it was determined that skin care applied to preterm newborns with sunflower oil reduced mortality by 26%, the duration of hospitalization was shorter in newborns treated with sunflower oil than the control group, and regular use of moisturizers had no effect on the incidence of infection. Recently, it has been reported that topical application of coconut oil is safe and feasible in very preterm infants and has beneficial effects on skin condition and recovery of infants. In a systematic review of randomized studies evaluating the effects of topical coconut oil in preterm infants, it was emphasized that in general, transepidermal fluid loss and infection rate were reduced in infants in the coconut oil group, the growth and skin integrity of the infants were better, and no significant side effects were experienced. In a study comparing coconut and carrot oils, it was stated that the skin flora and barrier function were better in babies using coconut oil.

Comparison of the application of Coconut and Sunflower Oil in the preservation of skin integrity, the amount of fluid ingested/extracted daily, and weight gain/decrease in infants hospitalized in the Neonatal Intensive Care Unit.

Conditions

Skin Care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental (coconut oil group)

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).

Group Type: EXPERIMENTAL

Coconut oil skin care group

Intervention Type: 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.

Experimental (sunflower oil group)

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).

Group Type: OTHER

Coconut oil skin care group

Intervention Type: 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.

No Intervention (Control group)

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Coconut oil skin care group

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.

Intervention Type: OTHER

Other Intervention Names

sunflower oil skin care group

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 34 Weeks
• Maximum Eligible Age: 37 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sakarya University

OTHER

Sponsor Role: lead

Responsible Party

öznur tiryaki

Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

NURSAN ÇINAR, Prof

Role: PRINCIPAL_INVESTIGATOR

Sakarya University

HAMİDE ZENGİN, Asis Prof

Role: PRINCIPAL_INVESTIGATOR

Bilecik Seyh Edebali Universitesi

İBRAHİM CANER, Prof

Role: PRINCIPAL_INVESTIGATOR

Sakarya University

ERTUĞRUL GÜÇLÜ, Prof

Role: PRINCIPAL_INVESTIGATOR

Sakarya University

ÖZNUR TİRYAKİ, PhD

Role: PRINCIPAL_INVESTIGATOR

Sakarya Education and Research Hospital

MELTEM KARABAY, Asis Prof

Role: STUDY_CHAIR

Sakarya University

Locations

Sakarya Education and Training Hospital

Sakarya, Adapazarı, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

0

Identifier Type: -

Identifier Source: org_study_id