Effects of Different Nasal Irrigation Methods on Pain Level, Crying and Procedure Times in Nasal Congestion in Infants

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

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.

Study Overview

• Status: Completed
• Conditions: Nasal Congestion; Nursing
• Intervention / Treatment: Procedure: Nasal irrigation with isotonic saline; Procedure: Nasal irrigation with hypertonic saline; Procedure: Nontraumatic nasopharyngeal aspiration

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İ̇stanbul
    • Kadıköy, İ̇stanbul, Turkey, 34862
      • Istanbul Medeniyet University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention 1 Group; The group received a nasal irrigation procedure with isotonic saline.	Procedure: Nasal irrigation with isotonic saline; Infants were placed on the examination stretcher in the right or left lateral position. Then, 10 mL of isotonic saline solution was administered over 5 s into the upper nasal cavity of the infant. The secretion and irrigation solution from the lower nasal cavity were cleaned using gauze. The infant was placed on the other side, and the same procedure was repeated for the other nasal cavity. The infant was then placed in the prone position, and the tapotement technique was applied. The infant's mouth and nose were cleaned with gauze, completing the procedure.
Experimental: Intervention 2 Group; The group received a nasal irrigation procedure with hypertonic saline.	Procedure: Nasal irrigation with hypertonic saline; Infants were placed on the examination stretcher in the right or left lateral position. Then, 10 mL of hypertonic saline solution was administered over 5 s into the upper nasal cavity of the infant. The secretion and irrigation solution from the lower nasal cavity were cleaned using gauze. The infant was placed on the other side, and the same procedure was repeated for the other nasal cavity. The infant was then placed in the prone position, and the tapotement technique was applied. The infant's mouth and nose were cleaned with gauze, completing the procedure.
Experimental: Intervention 3 Group; The group received a nasal irrigation procedure with isotonic saline and nontraumatic nasopharyngeal aspiration.	Procedure: Nasal irrigation with isotonic saline; Infants were placed on the examination stretcher in the right or left lateral position. Then, 10 mL of isotonic saline solution was administered over 5 s into the upper nasal cavity of the infant. The secretion and irrigation solution from the lower nasal cavity were cleaned using gauze. The infant was placed on the other side, and the same procedure was repeated for the other nasal cavity. The infant was then placed in the prone position, and the tapotement technique was applied. The infant's mouth and nose were cleaned with gauze, completing the procedure.; Procedure: Nontraumatic nasopharyngeal aspiration; After nasal irrigation, the secretions and saline solution from the underlying nasal cavity were nontraumatically aspirated from the entrance of the nasal cavity after the irrigation. The infant was positioned on the other side, and the same procedure was repeated for the other nasal cavity. The infant was then placed in the prone position, and the tapotement technique was applied. The infant's mouth and nose were cleaned with gauze, completing the procedure.
Experimental: Intervention 4 Group; The group received a nasal irrigation procedure with hypertonic saline and nontraumatic nasopharyngeal aspiration.	Procedure: Nasal irrigation with hypertonic saline; Infants were placed on the examination stretcher in the right or left lateral position. Then, 10 mL of hypertonic saline solution was administered over 5 s into the upper nasal cavity of the infant. The secretion and irrigation solution from the lower nasal cavity were cleaned using gauze. The infant was placed on the other side, and the same procedure was repeated for the other nasal cavity. The infant was then placed in the prone position, and the tapotement technique was applied. The infant's mouth and nose were cleaned with gauze, completing the procedure.; Procedure: Nontraumatic nasopharyngeal aspiration; After nasal irrigation, the secretions and saline solution from the underlying nasal cavity were nontraumatically aspirated from the entrance of the nasal cavity after the irrigation. The infant was positioned on the other side, and the same procedure was repeated for the other nasal cavity. The infant was then placed in the prone position, and the tapotement technique was applied. The infant's mouth and nose were cleaned with gauze, completing the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural pain score- FLACC Pain Scale	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.	1 minute before the heel lance procedure, at the end of the procedure
Crying time	The crying time was the duration of infants' crying from the start of the NI procedure to 5 min after the procedure.	Through painful procedure completion, an average of 5 minutes
Procedure time	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	Through painful procedure completion, an average of 2 minutes.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SpO2	In this study, SpO2 values of infants were measured 3 times.	1 minute before the procedure, at the end of the procedure, and 5 min after the procedure.
Heart rate /minute	In this study, heart rate /minute values of infants were measured 3 times.	1 minute before the procedure, at the end of the procedure, and and 5 min after the procedure.
Respiratory rate/ minute	In this study, Respiratory rate/ minute values of infants were measured 3 times.	1 minute before the procedure, at the end of the procedure, and 5 min after the procedure.

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University
• Investigators: Study Director: Aynur Aytekin Ozdemir, Professor, Istanbul Medeniyet University

Publications and helpful links

General Publications

• 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.
• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2022
• Primary Completion (Actual): November 8, 2022
• Study Completion (Actual): November 8, 2022

Study Registration Dates

• First Submitted: November 14, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Infant; nursing; nasal irrigation; nasal congestion; nasopharyngeal aspiration
• Other Study ID Numbers: 2022-01-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
• IPD Sharing Time Frame: September through December of 2025
• IPD Sharing Access Criteria: Individual participant data may be shared upon request from the principal investigator, subject to the appropriateness of the request, while ensuring adherence to the rules of confidentiality regarding individual data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No