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Mothers' Heartbeat Intervention in Newborn's Phototherapy Treatment at Maternity Ward

NCT07712978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-20

No results posted yet for this study

Summary

Neonatal jaundice is a common condition among newborns and may require phototherapy during the early postnatal period. Although phototherapy is an effective treatment for hyperbilirubinemia, it may be associated with maternal stress, anxiety, concern and disruption of closeness between the mother and newborn. This mixed methods feasibility study evaluates a mothers' heartbeat intervention designed to support maternal well-being and newborn comfort during phototherapy in a maternity ward setting.

The intervention uses a multisensory sleep pad placed under the newborn's mattress during phototherapy. At the beginning of the intervention, each mother's heartbeat, breathing sounds and chest vibrations are recorded and transferred to the pad. During phototherapy, the newborn can hear and feel these individually recorded maternal sounds and vibrations while lying on the mattress. The intervention is intended to provide womb-like auditory and tactile stimulation and to promote calmness, comfort and a sense of closeness during treatment.

The study includes mothers whose term newborns require phototherapy for jaundice at a maternity ward in Finland. A total of 40 mothers and newborns are included: 20 in the intervention group and 20 in the control group. Data are collected before and after phototherapy. Maternal outcomes include anxiety, stress and experience of phototherapy. The feasibility, usability and acceptability of the intervention are assessed among mothers in the intervention group. In addition, semi-structured interviews are conducted to explore mothers' experiences of successful factors related to the intervention.

The primary purpose of this feasibility study is to evaluate whether the mothers' heartbeat intervention is acceptable, usable and feasible in a maternity ward during newborn phototherapy. The study also examines preliminary effects on maternal anxiety, maternal stress and mothers' experiences of phototherapy. The findings will be used to inform the planning of a future larger randomized controlled trial.

Conditions

Interventions

DEVICE

Mothers' Heartbeat Intervention

The mothers' heartbeat intervention consists of individually recorded maternal heartbeat, breathing sounds and chest vibrations delivered to the newborn through a multisensory Nucu Pad placed under the mattress during phototherapy. The intervention is used in addition to usual phototherapy care.

Sponsors & Collaborators

  • University of Oulu

    collaborator OTHER

  • Mervi Hakala

    lead OTHER

Principal Investigators

  • Tarja Pölkki, Professor · University of Oulu

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-03
Primary Completion
2025-01-30
Completion
2025-01-30

Countries

  • Finland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07712978 on ClinicalTrials.gov