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Parental touch during diaper changes may soothe preterm infants

NCT ID NCT06345742

Knowledge-focused Sponsor: Acibadem University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study looked at whether having a parent help during diaper care makes preterm babies more comfortable. Researchers measured comfort levels in 105 preterm infants before, during, and after diaper changes done by a nurse alone versus with a mother or father. They also tracked parental stress. The goal was to see if parent involvement improves the baby's experience.

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

105 people

The number who actually took part.

Started

Dec 2023

Finished

Oct 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

Accepted

You do not need to have the condition being studied to take part.

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: * Infants whose gestational age is between ≥34 weeks and ≤36+6 weeks at the time of application * Infants with stable health conditions Exclusion Criteria: * Intubated * Those with very low and extremely low birth weight at the time of procedure * Having a chronic disease * Those with congenital anomalies * Having undergone a surgical procedure * Having neurological symptoms * Receiving oxygen support * Diagnosed with sepsis * Sedated * A pharmacological analgesic method was used four hours before. * Parents who do not want to participate in care

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Preterm

Contacts and locations

Locations

  • Acıbadem University

    Istanbul, Ataşehir, 34750, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.