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Gentle touch: new comfort care eases newborn pain after birth

NCT ID NCT07148570

Symptom relief Sponsor: Cukurova University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether nursing care based on Kolcaba's Comfort Theory could reduce pain and improve comfort in healthy, full-term newborns right after a vaginal birth. Sixty newborns were included. The approach focused on physical, emotional, and environmental comfort. Results may help improve standard care for newborns in the delivery room.

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

60 people

The number who actually took part.

Started

Aug 2025

Finished

Feb 2026

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

0 to 4 hours

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: * Vaginal delivery newborns in the delivery room * Spontaneous vaginal delivery * Stable condition (APGAR ≥7 at 5 minutes) * No congenital anomalies * Gestational age ≥37 weeks * Birth weight ≥2500g * No maternal sedation/analgesia in last 4 hours * No neonatal resuscitation required Exclusion Criteria: * Preterm infants (\<37 weeks) * Maternal fever (\>38°C) or chorioamnionitis * Major congenital anomalies * Need for NICU admission * Maternal general anesthesia

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Conditions

The condition(s) this trial relates to.

Pain

As listed by the trial registrant

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

Comfort Pain

Contacts and locations

Locations

  • Yuzuncu Yıl University

    Van, Tuşba, 65030, Turkey (Türkiye)

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