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

I

Istanbul Medeniyet University

Status

Completed

Conditions

Nursing
Nasal Congestion

Treatments

Procedure: Nasal irrigation with hypertonic saline
Procedure: Nasal irrigation with isotonic saline
Procedure: Nontraumatic nasopharyngeal aspiration

Study type

Interventional

Funder types

Other

Identifiers

NCT06691620
2022-01-22

Details and patient eligibility

About

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.

Full 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.

Enrollment

126 patients

Sex

All

Ages

6 to 24 months old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

126 participants in 4 patient groups

Intervention 1 Group
Experimental group
Description:
The group received a nasal irrigation procedure with isotonic saline.
Treatment:
Procedure: Nasal irrigation with isotonic saline
Intervention 2 Group
Experimental group
Description:
The group received a nasal irrigation procedure with hypertonic saline.
Treatment:
Procedure: Nasal irrigation with hypertonic saline
Intervention 3 Group
Experimental group
Description:
The group received a nasal irrigation procedure with isotonic saline and nontraumatic nasopharyngeal aspiration.
Treatment:
Procedure: Nontraumatic nasopharyngeal aspiration
Procedure: Nasal irrigation with isotonic saline
Intervention 4 Group
Experimental group
Description:
The group received a nasal irrigation procedure with hypertonic saline and nontraumatic nasopharyngeal aspiration.
Treatment:
Procedure: Nontraumatic nasopharyngeal aspiration
Procedure: Nasal irrigation with hypertonic saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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