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

NCT06691620 | Completed

• 1 other identifier: 2022-01-22
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Congestion; Nursing

Keywords

Infant; nasal congestion; nasal irrigation; nasopharyngeal aspiration; nursing

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• SpO2

  1 minute before the procedure, at the end of the procedure, and 5 min after the procedure.

• Heart rate /minute

  1 minute before the procedure, at the end of the procedure, and and 5 min after the procedure.

• Respiratory rate/ minute

  1 minute before the procedure, at the end of the procedure, and 5 min after the procedure.

Study Arms (4)

Intervention 1 Group

EXPERIMENTAL

The group received a nasal irrigation procedure with isotonic saline.

Procedure: Nasal irrigation with isotonic saline

Intervention 2 Group

EXPERIMENTAL

The group received a nasal irrigation procedure with hypertonic saline.

Procedure: Nasal irrigation with hypertonic saline

Intervention 3 Group

EXPERIMENTAL

The group received a nasal irrigation procedure with isotonic saline and nontraumatic nasopharyngeal aspiration.

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

Intervention 4 Group

EXPERIMENTAL

The group received a nasal irrigation procedure with hypertonic saline and nontraumatic nasopharyngeal aspiration.

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

Interventions

Nasal irrigation with isotonic saline PROCEDURE

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.

Intervention 1 Group; Intervention 3 Group

Nasal irrigation with hypertonic saline PROCEDURE

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.

Intervention 2 Group; Intervention 4 Group

Nontraumatic nasopharyngeal aspiration PROCEDURE

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.

Intervention 3 Group; Intervention 4 Group

Eligibility Criteria

• Age: 6 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Kadıköy, Istanbul, 34862, Turkey (Türkiye)

Location

Related Publications (3)

• 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

  BACKGROUND

• 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.

  PMID: 27513397 BACKGROUND

• 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.

  PMID: 32312677 BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Nasal Lavage; Sodium Chloride; Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Aynur Aytekin Ozdemir, Professor

  İstanbul Medeniyet University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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).

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 15, 2024
• Study Start: January 3, 2022
• Primary Completion: November 8, 2022
• Study Completion: November 8, 2022
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: September through December of 2025
• 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.

Locations

TU (1)