Nasal CongestionNCT06691620

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

A study testing Nasal irrigation with isotonic saline, Nasal irrigation with hypertonic saline and Nontraumatic nasopharyngeal aspiration in people with Nasal Congestion and Nursing, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 6 to 24 monthsHealthy volunteers can take part
Conditions the study is for: Nasal Congestion, Nursing
What is being tested?: Nasal irrigation with isotonic saline, Nasal irrigation with hypertonic saline and Nontraumatic nasopharyngeal aspiration
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 126 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 3 Jan 2022to 8 Nov 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 24 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul Medeniyet University
Kadıköy, Istanbul, 34862

Other trials in Turkey (Türkiye)

About this study

Official title: 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

Read the 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.

Conditions: Nasal Congestion, Nursing
Being tested: Nasal irrigation with isotonic saline, Nasal irrigation with hypertonic saline, Nontraumatic nasopharyngeal aspiration
Keywords: Infant, nasal congestion, nasal irrigation, nasopharyngeal aspiration, nursing
Medical subject headings: Nasal Obstruction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nasal irrigation with isotonic salineProcedure or surgery
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.
Nasal irrigation with hypertonic salineProcedure or surgery
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.
Nontraumatic nasopharyngeal aspirationProcedure or surgery
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.

Study groups in NCT06691620
Study group	Role	What they receive
Intervention 1 Group	Experimental	The group received a nasal irrigation procedure with isotonic saline. Receives: Procedure: Nasal irrigation with isotonic saline
Intervention 2 Group	Experimental	The group received a nasal irrigation procedure with hypertonic saline. Receives: Procedure: Nasal irrigation with hypertonic saline
Intervention 3 Group	Experimental	The group received a nasal irrigation procedure with isotonic saline and nontraumatic nasopharyngeal aspiration. Receives: 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. Receives: Procedure: Nasal irrigation with hypertonic saline; Procedure: Nontraumatic nasopharyngeal aspiration

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: Through painful procedure completion, an average of 2 minutes.

Secondary outcomes (3)

SpO2
In this study, SpO2 values of infants were measured 3 times.
Measured: 1 minute before the procedure, at the end of the procedure, and 5 min after the procedure.
Heart rate /minute
In this study, heart rate /minute values of infants were measured 3 times.
Measured: 1 minute before the procedure, at the end of the procedure, and and 5 min after the procedure.
Respiratory rate/ minute
In this study, Respiratory rate/ minute values of infants were measured 3 times.
Measured: 1 minute before the procedure, at the end of the procedure, and 5 min after the procedure.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 20228 Nov 2022

First posted15 Nov 2024
Study start3 Jan 2022
Primary completion8 Nov 2022
Study completion8 Nov 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Nasal CongestionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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).
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 126 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06691620
Sponsor's protocol ID: 2022-01-22
Status last verified: Nov 2024
First submitted: 14 Nov 2024
Last updated: 15 Nov 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

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
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.
PubMed 27513397
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.
PubMed 32312677

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
RecruitingPhase 3
Fixed-dose Combination of 1000 mg Dipyrone Monohydrate + 60 mg Caffeine + 4 mg Chlorpheniramine Maleate in Improving Symptoms of the Common Cold and Flu in Adults
Common Cold/Flu, Nasal Congestion
Not yet recruitingObservational study
Observational Study of RHINOSEDAL in Acute Nasal Obstruction
Nasal Obstruction, Common Cold
Active, not recruiting
Laser Posterior Nasal Nerve Neurolysis
Allergic Rhinitis, Chronic Rhinitis
Not yet recruiting
Vibroacoustic Therapy With Oscillating Positive Expiratory Pressure in the Treatment of Nasal Congestion
Atopic Rhinitis, Atopic Asthma

All Nasal Congestion trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06691620
Acronym / sponsor ID: 2022-01-22
Conditions: Nasal Congestion, Nursing
Keywords: Infant, nasal congestion, nasal irrigation, nasopharyngeal aspiration, nursing
Study type: Interventional
Recruitment status: Completed
Enrolment: 126 participants (actual)
Lead sponsor: Istanbul Medeniyet UniversityUniversity, hospital or other
Study start: 3 Jan 2022 (actual)
Primary completion: 8 Nov 2022 (actual)
Study completion: 8 Nov 2022 (actual)
First posted: 15 Nov 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4
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).

Arm	Type	Receives
Intervention 1 Group	Experimental	Procedure: Nasal irrigation with isotonic salineThe group received a nasal irrigation procedure with isotonic saline.
Intervention 2 Group	Experimental	Procedure: Nasal irrigation with hypertonic salineThe group received a nasal irrigation procedure with hypertonic saline.
Intervention 3 Group	Experimental	Procedure: Nasal irrigation with isotonic saline, Procedure: Nontraumatic nasopharyngeal aspirationThe group received a nasal irrigation procedure with isotonic saline and nontraumatic nasopharyngeal aspiration.
Intervention 4 Group	Experimental	Procedure: Nasal irrigation with hypertonic saline, Procedure: Nontraumatic nasopharyngeal aspirationThe group received a nasal irrigation procedure with hypertonic saline and nontraumatic nasopharyngeal aspiration.

Who may qualify

Ages: 6 to 24 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nasal irrigation with isotonic salineInfants 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.	Procedure or surgery	Intervention 1 Group, Intervention 3 Group
Nasal irrigation with hypertonic salineInfants 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.	Procedure or surgery	Intervention 2 Group, Intervention 4 Group
Nontraumatic nasopharyngeal aspirationAfter 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.	Procedure or surgery	Intervention 3 Group, Intervention 4 Group

Primary outcome

Procedural pain score- FLACC Pain Scale
Time frame: 1 minute before the heel lance procedure, at the end of the procedure
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.
Crying time
Time frame: Through painful procedure completion, an average of 5 minutes
The crying time was the duration of infants' crying from the start of the NI procedure to 5 min after the procedure.
Procedure time
Time frame: Through 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

3 secondary outcomes

SpO2
Time frame: 1 minute before the procedure, at the end of the procedure, and 5 min after the procedure.
Heart rate /minute
Time frame: 1 minute before the procedure, at the end of the procedure, and and 5 min after the procedure.
Respiratory rate/ minute
Time frame: 1 minute before the procedure, at the end of the procedure, and 5 min after the procedure.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
Results publicationAvşar 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
Results publication: PubMed 27513397Koksal 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.
Results publication: PubMed 32312677Cabaillot 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.
Individual participant dataSharing planned: Yes. 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.

Related trials for Nasal Congestion

Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
RecruitingPhase 3
Fixed-dose Combination of 1000 mg Dipyrone Monohydrate + 60 mg Caffeine + 4 mg Chlorpheniramine Maleate in Improving Symptoms of the Common Cold and Flu in Adults
Common Cold/Flu, Nasal Congestion
Not yet recruitingObservational study
Observational Study of RHINOSEDAL in Acute Nasal Obstruction
Nasal Obstruction, Common Cold
Active, not recruiting
Laser Posterior Nasal Nerve Neurolysis
Allergic Rhinitis, Chronic Rhinitis
Not yet recruiting
Vibroacoustic Therapy With Oscillating Positive Expiratory Pressure in the Treatment of Nasal Congestion
Atopic Rhinitis, Atopic Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aynur Aytekin Ozdemir, Professor study director

İstanbul Medeniyet University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedural pain score- FLACC Pain Scale (time frame: 1 minute before the heel lance procedure, at the end of the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06691620, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.