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

NCT ID: NCT06002594

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-15
• Study Completion Date: 2019-10-29

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.

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.

Conditions

Upper Respiratory Tract Infection; Nasal Congestion and Inflammations

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

group low-volume irrigation

Nasal irrigation was performed using low-volume saline solution

Group Type: EXPERIMENTAL

group low-volume irrigation

Intervention Type: OTHER

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.

group high-volume irrigation

Nasal irrigation was performed using high-volume saline solution

Group Type: EXPERIMENTAL

group high-volume irrigation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nevin Avsar

nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nevin AVŞAR GÖK

Role: PRINCIPAL_INVESTIGATOR

University of Health Sciences Sisli Hamidiye Etfal Training and Research Hospital

Locations

University of Health Sciences Sisli Hamidiye Etfal Training and Research Hospital

Istanbul, Sarıyer, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Sislietfal-SBF-NAG-01

Identifier Type: -

Identifier Source: org_study_id