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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06691620
Enrollment
126
Registered
2024-11-15
Start date
2022-01-03
Completion date
2022-11-08
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Congestion, Nursing

Keywords

Infant, nasal congestion, nasal irrigation, nasopharyngeal aspiration, nursing

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.

Interventions

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.

PROCEDURENasal 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.

PROCEDURENontraumatic 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.

Sponsors

Istanbul Medeniyet University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

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).

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).

Eligibility

Sex/Gender
ALL
Age
6 Months to 24 Months
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Procedural pain score- FLACC Pain Scale1 minute before the heel lance procedure, at the end of the procedureThe 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 timeThrough painful procedure completion, an average of 5 minutesThe crying time was the duration of infants' crying from the start of the NI procedure to 5 min after the procedure.
Procedure timeThrough 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

MeasureTime frameDescription
SpO21 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 /minute1 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/ minute1 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026