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Swaddling after bath may soothe newborns, small study suggests

NCT ID NCT06171997

Symptom relief Sponsor: Funda Kardas Ozdemir Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether safely swaddling newborns right after a bath helps lower their stress and improve comfort. Researchers observed 72 babies in a neonatal intensive care unit in Turkey, measuring stress and comfort before and after bathing and swaddling. The goal is to find a simple, gentle way to make bath time less upsetting for newborns.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
safe swaddling procedure
What this could lead to
If effective, this simple technique could become a standard practice to help newborns feel more relaxed and less stressed after bathing.
What could go wrong
This is a small, single-site study with only 72 babies. Results may not apply to all newborns, and the effect may be small or not reproducible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

72 people

The number who actually took part.

Started

Feb 2022

Finished

Feb 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 day to 28 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The week of gestation is between 37 and 41 weeks, * Birth weight being 2500 g and above, * Having spontaneous breathing, * Its physiological parameters are stable, * Having completed the first 24 hours of life, * No invasive interventions should be made before the bathing process. Exclusion Criteria: Preterms with a gestational age of 22-37 weeks, * Connected to mechanical ventilator, * Those who have been wiped or bathed in the last 12 hours, * Within the first 78 hours of the post-operative period, * With central catheter, * Diagnosed with sepsis, * Those who use sedative and/or muscle relaxants, * Those with congenital, chromosomal anomalies,

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Comfort Stress

Contacts and locations

Locations

  • Kafkas University

    Kars, Kars, 36100, Turkey (Türkiye)

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