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Gentle touch soothes preterm Babies' pain, study finds

NCT ID NCT07470398

Symptom relief Sponsor: Karbala 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 Results may not be published yet.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)
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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
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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This status has not been confirmed recently, so it may be out of date.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 a gentle touch technique can help reduce pain and keep breathing stable in preterm infants during painful procedures in the NICU. Researchers compared 60 babies who received gentle touch with those who got standard care. The goal was to see if this simple, drug-free method could make procedures less stressful for these tiny patients.

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

Sep 2025

Finished

Jan 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 30 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: * Preterm infants with a gestational age range from 28 to 36 weeks. * Preterm infants admitted to the neonatal units of the selected teaching hospitals. * Preterm infants who were clinically stable at the time of data collection. * Preterm infants undergoing routine painful procedures as part of standard neonatal care. * Preterm infants who did not receive analgesic or sedative medications prior to the procedure. * Preterm infants whose parents or legal guardians agreed to participate in the study and provided informed consent. Exclusion Criteria: * Preterm infants with a gestational age of less than 28 weeks or more than 36 weeks. * Preterm infants with congenital anomalies or genetic disorders. * Preterm infants diagnosed with neurological impairment or central nervous system disorders. * Preterm infants who were clinically unstable or required intensive medical interventions at the time of data collection. * Preterm infants receiving analgesic or sedative medications prior to the painful procedures. * Preterm infants with severe respiratory distress or requiring mechanical ventilation. * Preterm infants who had undergone any painful procedure within 30 minutes prior to the study procedure.

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Conditions

The condition(s) this trial relates to.

Pain, Procedural

As listed by the trial registrant

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

Preterm infants Procedural pain

Contacts and locations

Locations

  • Al-Hindiya Teaching Hospital

    Karbala, Kerbala, 56001, Iraq

  • Karbala Teaching Hospital for Children

    Karbala, Kerbala, 56001, Iraq

  • Obstetrics and Gynecology Teaching Hospital

    Karbala, Kerbala, 56001, Iraq

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