Clinical trial NCT06691620: Effects of Different Nasal Irrigation Methods on Pain Level, Crying and Procedure Times in Nasal Congestion in Infants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasal Congestion
Nursing
Keywords: Infant
nasal congestion
nasal irrigation
nasopharyngeal aspiration
nursing
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2024-11-15
Enrollment: 126
Sex: ALL
Minimum age (years): 6
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were assigned to the groups using the block randomization method. Age (6-12 and 13-24 months) and sex (male and female) were used as variables for randomization. Blocks were repeated eight times in each group to achieve the calculated sample size, and 32 participants were included in each group. An online tool was used to generate the randomization list with 2 × 2 × 8 blocks (Sealed Envelope Ltd., 2022).
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Procedural pain score- FLACC Pain Scale
timeFrame: 1 minute before the heel lance procedure, at the end of the procedure
measure: Crying time
timeFrame: Through painful procedure completion, an average of 5 minutes
measure: Procedure time
timeFrame: Through painful procedure completion, an average of 2 minutes.
Secondary outcomes:
measure: SpO2
timeFrame: 1 minute before the procedure, at the end of the procedure, and 5 min after the procedure.
measure: Heart rate /minute
timeFrame: 1 minute before the procedure, at the end of the procedure, and and 5 min after the procedure.
measure: Respiratory rate/ minute
timeFrame: 1 minute before the procedure, at the end of the procedure, and 5 min after the procedure.
Other outcomes:
Locations:
city: Kadıköy
country: Turkey
facility: Istanbul Medeniyet University
state: İ̇stanbul
Study officials:
affiliation: İstanbul Medeniyet University
name: Aynur Aytekin Ozdemir, Professor
role: STUDY_DIRECTOR
References:
citation: Avşar Gök, N. & Bozkurt, G. (2023). Effects of two different nasal irrigation techniques on physiological parameters and crying duration in relieving nasal congestion in infants. Authorea, in press
citation: Koksal T, Cizmeci MN, Bozkaya D, Kanburoglu MK, Sahin S, Tas T, Yuksel CN, Tatli MM. Comparison between the use of saline and seawater for nasal obstruction in children under 2 years of age with acute upper respiratory infection. Turk J Med Sci. 2016 Jun 23;46(4):1004-13. doi: 10.3906/sag-1507-18.
citation: Cabaillot A, Vorilhon P, Roca M, Boussageon R, Eschalier B, Pereirad B. Saline nasal irrigation for acute upper respiratory tract infections in infants and children: A systematic review and meta-analysis. Paediatr Respir Rev. 2020 Nov;36:151-158. doi: 10.1016/j.prrv.2019.11.003. Epub 2020 Feb 21.