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Could a Mother's heartbeat ease stress during newborn phototherapy?

NCT ID NCT07712978

Symptom relief Sponsor: Mervi Hakala 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study tests whether playing a recording of a mother's heartbeat, breathing, and chest vibrations to her newborn during phototherapy for jaundice can reduce maternal anxiety and stress. Forty mothers and their full-term newborns will take part, with half receiving the heartbeat intervention and half receiving standard care. The goal is to see if this simple, womb-like sound and vibration therapy is practical and comforting in a maternity ward.

What this could mean

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

Active substance
A multisensory sleep pad that plays the mother's recorded heartbeat, breathing sounds, and chest vibrations to the newborn during phototherapy.
What this could lead to
If it works, this simple, low-cost intervention could help mothers feel less anxious and more connected to their newborns during a common medical treatment.
What could go wrong
This is a small feasibility study with only 40 participants, so results may not apply widely. The intervention may not significantly reduce anxiety or stress compared to standard care.

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

40 people

The number who actually took part.

Started

Jul 2024

Finished

Jan 2025

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

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 mother has given birth at the study hospital. * The mother's newborn requires phototherapy for neonatal jaundice during postnatal care in the maternity ward. * The newborn is born at term, between 37+0 and 41+6 gestational weeks. * Phototherapy is provided in a normal patient room or family room in the maternity ward where the mother or parents room-in with the newborn. * The mother is able to understand Finnish. * The mother is able to provide informed consent. * The mother is willing to participate in the study. Exclusion Criteria: Mothers are excluded if any of the following criteria apply: * Sensory impairment affecting participation, including significant visual or hearing impairment. * Inability to understand Finnish. * Postpartum complications requiring special attention or care, including pre-eclampsia, complicated infection or spinal headache. Newborns are excluded if any of the following criteria apply: * Phototherapy is started within 24 hours after birth. * Phototherapy is started at night. * The newborn receives home phototherapy. * The newborn is born before 37+0 gestational weeks or after 41+6 gestational weeks.

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Jaundice

As listed by the trial registrant

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

Anxiety Experience Stress

Contacts and locations

Locations

  • Oulu University Hospital

    Oulu, 90220, Finland

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