Examination of the Effectiveness of Nasal Irrigation Techniques in Infants With Nasal Congestion

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06002594

Collaborator

(none)

Enrollment

Location

Arms

2.5

Actual Duration (Months)

32.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The research investigates the effects of high-volume and low-volume nasal irrigation techniques applied to relieve nasal congestion in infants with nasal congestion due to upper respiratory tract infections. The study examines the physiological parameters of infants who undergo nasal irrigation, crying duration, frequency of the procedure, and the baby's feeding patterns.

Condition or Disease	Intervention/Treatment	Phase
Upper Respiratory Tract Infection Nasal Congestion and Inflammations	Other: group low-volume irrigation Other: group high-volume irrigation	N/A

Detailed Description

This study aims to investigate the effects of two different nasal irrigation techniques applied to relieve nasal congestion on infants' physiological parameters, crying duration, feeding habits, and the frequency of the procedure repetitions.

A randomized controlled experimental study was conducted with 80 infants aged 1-12 months who presented at the pediatric emergency clinic with nasal congestion due to upper respiratory tract infection. In the study, the 1st group of infants received low-volume saline solution, while the 2nd group received high-volume saline solution for nasal irrigation. Physiological parameters were measured before the procedure, immediately after the procedure, and 5 minutes after the procedure. Procedure duration and baby's crying duration were recorded. Subsequently, breastfeeding was initiated for the infants, and their physiological parameters were measured again during breastfeeding. Parental satisfaction levels with the procedure were also assessed. Finally, the frequency of the procedure repetitions was recorded.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

two groups were randomly selected and received two different treatmentstwo groups were randomly selected and received two different treatments

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Effects of Two Different Nasal Irrigation Techniques on Physiological Parameters, Crying Duration, and Feeding in Relieving Nasal Congestion in Infants

Actual Study Start Date :

Aug 15, 2019

Actual Primary Completion Date :

Oct 29, 2019

Actual Study Completion Date :

Oct 29, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group low-volume irrigation Nasal irrigation was performed using low-volume saline solution	Other: group low-volume irrigation Before the procedure, infants' physiological parameters were measured using the Nellcor Bedside SpO2 Patient Monitoring System. The procedure duration and crying duration were recorded using the stopwatch on a Samsung Galaxy A50 phone. Nasal irrigation was performed using 4 ml of 0.9% sodium chloride(NaCl) solution. Physiological parameters were measured immediately after the procedure and five minutes later. Subsequently, breastfeeding was initiated for the baby. Physiological parameters during breastfeeding were measured, and parental satisfaction levels were evaluated. Then, the frequency of procedure repetitions was recorded.
Experimental: group high-volume irrigation Nasal irrigation was performed using high-volume saline solution	Other: group high-volume irrigation Before the procedure, infants' physiological parameters were measured using the Nellcor Bedside SpO2 Patient Monitoring System. The procedure duration and crying duration were recorded using the stopwatch on a Samsung Galaxy A50 phone. Nasal irrigation was performed using 20 ml of 0.9% NaCl solution. Physiological parameters were measured immediately after the procedure and five minutes later. Subsequently, breastfeeding was initiated for the baby. Physiological parameters during breastfeeding were measured, and parental satisfaction levels were evaluated. Then, the frequency of procedure repetitions was recorded.

Arm

Intervention/Treatment

Experimental: group low-volume irrigation

Nasal irrigation was performed using low-volume saline solution

Other: group low-volume irrigation

Before the procedure, infants' physiological parameters were measured using the Nellcor Bedside SpO2 Patient Monitoring System. The procedure duration and crying duration were recorded using the stopwatch on a Samsung Galaxy A50 phone. Nasal irrigation was performed using 4 ml of 0.9% sodium chloride(NaCl) solution. Physiological parameters were measured immediately after the procedure and five minutes later. Subsequently, breastfeeding was initiated for the baby. Physiological parameters during breastfeeding were measured, and parental satisfaction levels were evaluated. Then, the frequency of procedure repetitions was recorded.

Experimental: group high-volume irrigation

Nasal irrigation was performed using high-volume saline solution

Other: group high-volume irrigation

Before the procedure, infants' physiological parameters were measured using the Nellcor Bedside SpO2 Patient Monitoring System. The procedure duration and crying duration were recorded using the stopwatch on a Samsung Galaxy A50 phone. Nasal irrigation was performed using 20 ml of 0.9% NaCl solution. Physiological parameters were measured immediately after the procedure and five minutes later. Subsequently, breastfeeding was initiated for the baby. Physiological parameters during breastfeeding were measured, and parental satisfaction levels were evaluated. Then, the frequency of procedure repetitions was recorded.

Outcome Measures

Primary Outcome Measures

The Effect of Low-Volume and High-Volume Nasal Irrigation Techniques on Infant's Physiological Parameters [3 months]
Prior to low and high-volume nasal irrigation procedures, infants' average peripheral oxygen saturation (SpO2), average heart rate per minute, and average respiratory rate per minute will be measured immediately before the procedure, immediately after the procedure, and five minutes after the procedure. The aim is to examine the effect of irrigation on physiological parameters.

Secondary Outcome Measures

The Effect of Nasal Irrigation Procedure on Procedure Duration, Infant Crying Duration, and Procedure Repetition Frequency [3 months]
Since the irrigation procedure can be distressing for the infant, two stopwatches were initiated to measure the duration of crying associated with the procedure. One was started just before the nasal irrigation procedure, and the other when the infant began crying. The first stopwatch was stopped after the procedure, while the second stopwatch was stopped when the infant's crying ceased. For infants with persistent post-irrigation nasal congestion, the procedure was repeated at 15-minute intervals, and the number of procedure repetitions was recorded.

Other Outcome Measures

The Impact of Nasal Irrigation Techniques on Infant Feeding [3 months]
After the nasal irrigation procedures, breastfeeding was initiated. During breastfeeding, average peripheral oxygen saturation (SpO2), average heart rate per minute, and average respiratory rate per minute were recorded. Following breastfeeding, mothers were asked to assess their current breastfeeding performance compared to the baby's performance before the procedure, and their satisfaction level with the procedure was recorded by inquiring about their level of contentment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 12 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Infants diagnosed with Upper Respiratory Tract Infection and recommended nasal cleaning with saline solution by a physician,
Infants whose parents provided consent for their participation in the research,
Term-born infants aged 1 month to 12 months,
Breastfed infants,
Infants without chronic illnesses,
Conscious infants,

Exclusion Criteria:

Infants with congenital anomalies affecting the respiratory system (such as choanal atresia, etc.),
Infants with allergic rhinitis,
Infants who used antibiotics or corticosteroids before hospital admission,
Infants with growth retardation, were excluded from the study.