The Effect of Hydrocolloid Tape and Facial Massage on Nasal Injury, Comfort and Stress in Premature Infants During Noninvasive Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Neonatal Skin Condition Score
研究概览
简要总结
The aim of this study is to assess the effect of nasal injury prevention interventions (NIPI) (hydrocolloid tape and facial massage) on nasal septum injury, stress and comfort of premature neonates (28-35 weeks gestation) receiving non-invasive mechanical ventilation (NIMV) support.
详细描述
The aim of this study is to assess the effect of nasal injury prevention interventions (NIPI) (hydrocolloid tape and facial massage) on nasal septum injury, stress and comfort of premature neonates receiving non-invasive mechanical ventilation (NIMV) support.
This study is a, prospective randomized controlled trial. The population for the research will comprise 108 premature neonates from 28-35 weeks gestation receiving NIMV support in the neonatal intensive care unit (NICU) from March 2023 to March 2024. Participants will be randomly assigned to one of three groups; the first group (n=40) will have hydrocolloid tape applied, the second group (n=40) will have facial massage and the third group (n=40 will be the control group. Research data will be collected with the Neonatal Descriptive Information Form, Nasal Injury Score Table (NIST), Neonate Skin Condition Scale (NSCS), Premature Infant Comfort Scale (COMFORT) and Neonatal Stress Scale (NSS).
Intervention Tools:
The NICU where the study will be performed uses SLEE 2000 and SLEE 5000 model mechanical ventilators. Both mechanical ventilators have no difference in implementation modes for invasive and non-invasive mechanical ventilation for term and premature infants. All premature infants included in the study will have NIMV support provided using SLEE 2000 and SLEE 5000 model mechanical ventilators. For NIMV of premature infants, NeoSmart brand (Mediplast Respiratory Products Sdn. Bhd, Malaysia) nasal cannulas will be used. The nasal cannula has soft binasal prongs and suitable structure for low- and high-flow oxygen use. A new sterile cannula will be used for each infant. There are 5 different sizes of x small, small, medium, large and x large. The sizes most frequently used for premature infants are small and medium.
In the hydrocolloid barrier group, Comfeel Plus brand hydrocolloid tape will be used. Hydrocolloid tape is a dressing cover made of soft, flexible and economic material in the form of a semi-permeable film or foam-supported gel (Başara, 2022; Ribeiro et al., 2020; Imbulana et al., 2018). Air exchange continues due to the semipermeable film on the top, while entry of harmful microorganisms to the region is prevented, healing is accelerated by creating a humid environment for the wound and exudate from the wound is absorbed. These features reduce the risk of developing infection and ensure patient comfort (Başara, 2022; Ribeiro et al., 2020; Imbulana et al., 2018; Fletcher et al. 2011; Xie, 2014). There is no specific change time, though generally the tape is changed every 3-5 days; however, it may remain in place for up to 7 days (Ribeiro et al., 2020; Fletcher et al. 2011).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
After the preterm neonates abiding by the inclusion criteria in the research are randomly allocated to the study groups, parents will provide written consent with an informed volunteer consent form without giving parents information about which group their infant will be included in. The researcher will apply the hydrocolloid barrier and facial massage themselves, so the researcher will not be blinded. However, to prevent bias, research outcome measures will be recorded by two nurses who are employed in the NICU, are university graduates and who do not know which infant is in the experiment or control groups. With the aim of preventing bias during analysis of data, the database for the study groups will be coded A, B and C by someone other than the researcher, and analysis of data will be performed by an independent statistical expert. Blinding of outcome measures, statistical analysis and reporting will be performed with the aim of preventing statistical and reporting bias.
入排标准
- 年龄范围
- 28 Weeks 至 35 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm neonates between 28-34 weeks gestation,
- •Preterm neonates beginning nasal NIMV due to respiratory distress within the first six hours after birth,
- •Preterm neonates with nasal NIMV after invasive mechanical ventilation,
- •Preterm neonates with parental consent to participate in the study.
排除标准
- •Preterm neonates with congenital anomaly (choanal atresia, cleft palate-lip, esophagus atresia, tracheoesophageal fistula, etc.),
- •Preterm neonates beginning NIMV support after more than 24 hours,
- •Preterm neonates with skin diseases (ichthyosis, etc.),
- •Preterm neonates with pulmonary hypertension.
结局指标
主要结局
Neonatal Skin Condition Score
时间窗: 3 days
This is a 3-item scale developed to assess the dryness and presence and degree of erythema and disruption/peeling of the skin in preterm, term and post-term infants admitted to the NICU.
Nasal Injury Score Table
时间窗: 3 days
The nasal injury score table was developed and was designed with the aim of assessing nasal injury in neonates receiving NIMV support. Pressure injury forming in 6 different anatomical regions of the nose is assessed from 0-4 points and the total points are obtained.
次要结局
- COMFORT scale(every 12-hour shift over 3 days for assessment.)
- Neonatal Stress Scale(every 12-hour shift over 3 days for assessment.)
研究者
Dilek Kucuk Alemdar
Associate professor
T.C. ORDU ÜNİVERSİTESİ