CompletedNot Applicable

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

Finland40 participantsStarted 2024-07-03

Plain-language 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.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility, usability and acceptability of the mothers' heartbeat intervention

Timeframe: After completion of phototherapy, approximately 24 hours after the start of phototherapy

Trial details

NCT IDNCT07712978

SponsorMervi Hakala

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-30

View on ClinicalTrials.gov More Anxiety trials

Plain-language summary

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.