Effects of Different Nasal Irrigation Methods on Pain Level, Crying and Procedure Times, and Physiologic Parameters in Nasal Congestion in Infants: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Procedural pain score- FLACC Pain Scale
研究概览
简要总结
This study aimed to evaluate the effects of different nasal irrigation (NI) methods for relieving nasal obstruction on pain, crying and procedure times, and physiologic parameters in infants with acute upper respiratory tract infection.
详细描述
Acute upper respiratory tract infections (URTIs) are the leading cause of acute disease incidence worldwide. Nasal saline irrigation (NSI) is a recommended approach to relieve nasal symptoms and maintain upper airway patency in children, offering a safe, inexpensive, and well-tolerated symptomatic treatment for children with URTIs. Nasal irrigation (NI) relieves URTI symptoms by clearing mucus, reducing congestion, and improving breathing. NI techniques and irrigation solutions used to relieve nasal obstruction in infants are effective in providing procedural comfort. Considering the effectiveness of NI in relieving nasal congestion, which negatively influences the quality of life of children, filling the gap in the literature on NSI is crucial. This study was conducted to determine the effects of various NI methods (NI/NI + nontraumatic nasopharyngeal aspiration) using different irrigation solutions on pain, crying and procedure times, and physiologic parameters in infants with URTIs aged 6 months to 2 years.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Using the block randomization technique, participants were divided into four groups. A web-based randomization list generation tool was used to assign participants to groups. Control and intervention groups were coded as A, B, C and D using the sealed envelope method. Randomization information was withheld from the researcher involved in data collection until data was collected. The researcher determines which group each baby is in. The researcher found out during the painful procedure. (investigator blinding). Within the scope of the research, parents knew which group the baby was in. However, due to the nature of the sample group, the babies were blind. To avoid statistical bias, study groups were coded as A, B, C and D; statistical blinding was performed (statistician blinding).
入排标准
- 年龄范围
- 6 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •infants aged between 6 months and 24 months, born at term, and recommended NSI for nasal cleansing by the physician due to a diagnosis of URTI.
排除标准
- •infants with chronic diseases, nasal congestion due to reasons other than URTI, congenital anomalies related to the respiratory system, allergic rhinitis, unconsciousness, use of analgesics, antibiotics, and corticosteroids before admission to the hospital, and developmental retardation.
结局指标
主要结局
Procedural pain score- FLACC Pain Scale
时间窗: 1 minute before the heel lance procedure, at the end of the procedure
The Face, Legs, Activity, Cry, and Consolability (FLACC) scale consists of five categories (face, legs, activity, crying, and consolability), and each category is scored between 0 and 2 depending on the pain or distress behaviors observed. The total score ranges from 0 to 10, with 0 indicating no pain or distress and 10 indicating extreme pain or distress. The FLACC scale was developed to assess pain in children aged 2 months to 7 years and is one of the widely recommended scales for assessing pain and distress among pediatric patients.
Crying time
时间窗: Through painful procedure completion, an average of 5 minutes
The crying time was the duration of infants' crying from the start of the NI procedure to 5 min after the procedure.
Procedure time
时间窗: Through painful procedure completion, an average of 2 minutes.
The procedure started with positioning the infant to apply NI in the first nasal cavity and ended with the completion of NI in the second nasal cavity
次要结局
- SpO2(1 minute before the procedure, at the end of the procedure, and 5 min after the procedure.)
- Heart rate /minute(1 minute before the procedure, at the end of the procedure, and and 5 min after the procedure.)
- Respiratory rate/ minute(1 minute before the procedure, at the end of the procedure, and 5 min after the procedure.)
研究者
Aynur Aytekin Ozdemir
Professor
Istanbul Medeniyet University