Effects of Different Nasal Irrigation Methods on Pain Level, Crying and Procedure Times in Nasal Congestion in Infants
- Conditions
- NursingNasal Congestion
- Registration Number
- NCT06691620
- Lead Sponsor
- Istanbul Medeniyet University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Procedural pain score- FLACC Pain Scale 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 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 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
- Secondary Outcome Measures
Name Time Method SpO2 1 minute before the procedure, at the end of the procedure, and 5 min after the procedure. In this study, SpO2 values of infants were measured 3 times.
Heart rate /minute 1 minute before the procedure, at the end of the procedure, and and 5 min after the procedure. In this study, heart rate /minute values of infants were measured 3 times.
Respiratory rate/ minute 1 minute before the procedure, at the end of the procedure, and 5 min after the procedure. In this study, Respiratory rate/ minute values of infants were measured 3 times.
Trial Locations
- Locations (1)
Istanbul Medeniyet University
🇹🇷Kadıköy, İ̇stanbul, Turkey