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

Mothers' Heartbeat Intervention in Newborn's Phototherapy Treatment at Maternity Ward: A Mixed Methods Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Stress; Anxiety; Experience
• Intervention / Treatment: Device: Mothers' Heartbeat Intervention

Detailed Description

Neonatal jaundice is one of the most common conditions requiring treatment during the early postnatal period. Phototherapy is an effective and widely used treatment for neonatal hyperbilirubinemia, but the treatment situation may be stressful for mothers. During phototherapy, the newborn may need to remain under phototherapy lights or on a phototherapy blanket for prolonged periods, which may limit normal closeness, skin-to-skin contact and uninterrupted interaction between the mother and newborn. Mothers may experience stress, anxiety, concern and uncertainty related to their newborn's condition, treatment procedures and the need to maintain effective phototherapy exposure.

This mixed methods feasibility study evaluates a mothers' heartbeat intervention during newborn phototherapy in a maternity ward setting. The intervention is designed to provide individually recorded maternal auditory and tactile stimulation to the newborn during phototherapy and to support maternal well-being, newborn comfort and maternal-newborn closeness. The intervention uses a multisensory sleep pad placed under the newborn's mattress. At the beginning of the intervention, the mother's heartbeat, breathing sounds and chest vibrations are recorded. These individually recorded maternal sounds and vibrations are transferred to the sleep pad. During phototherapy, the newborn can hear and feel the mother's recorded heartbeat, breathing sounds and vibrations while lying on the mattress.

The intervention is intended to create womb-like auditory and tactile stimulation and to provide a familiar maternal sensory environment during treatment. The newborn receives usual phototherapy care according to standard clinical practice, and the mothers' heartbeat intervention is used as an additional supportive intervention. The newborn remains in phototherapy as much as possible to achieve the intended treatment effect, and usual care activities such as feeding, diaper changing and drying are carried out according to normal maternity ward routines.

The study is conducted as a mixed methods feasibility study with a quasi-experimental pilot design and qualitative interviews. A total of 40 mothers and their term newborns requiring phototherapy for jaundice are included. The intervention group includes 20 mothers and newborns who receive the mothers' heartbeat intervention in addition to usual phototherapy care. The control group includes 20 mothers and newborns who receive usual phototherapy care only. Data are collected in two consecutive periods from June 2024 to January 2025 in a university hospital maternity ward in Finland.

The study population consists of mothers whose newborns are born at 37+0 to 41+6 gestational weeks and require phototherapy for jaundice during postnatal care in the maternity ward. Phototherapy is provided in a normal patient room or family room where the mother or parents room-in with the newborn. Phototherapy may be delivered using a Bilisoft Blanket, overhead phototherapy lights or both, according to clinical need and standard care.

The feasibility, usability and acceptability of the mothers' heartbeat intervention are assessed among mothers in the intervention group using the System Usability Scale after phototherapy. Maternal anxiety is measured before and after phototherapy using the State-Trait Anxiety Inventory, state anxiety form. Maternal stress is measured before and after phototherapy using a verbal rating scale for stress. Mothers' experience of phototherapy is assessed after phototherapy using a numerical rating scale. In addition, mothers in the intervention group participate in semi-structured interviews after phototherapy to explore their experiences of the successful factors related to the intervention.

The primary purpose of this feasibility study is to evaluate whether the mothers' heartbeat intervention is feasible, usable and acceptable in a maternity ward setting during newborn phototherapy. The study also examines preliminary effects on maternal anxiety, maternal stress and mothers' experiences of phototherapy. Qualitative interview data are used to provide a deeper understanding of how mothers experience the intervention, including its perceived calming effects, user-friendliness and role as a facilitating element during phototherapy.

The findings from this feasibility study will inform the development and planning of a future larger randomized controlled trial. The study may provide preliminary evidence on whether a simple, non-invasive and individually tailored sensory intervention can support mothers and newborns during phototherapy and improve the care experience in maternity ward settings.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90220
    • Oulu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mothers' Heartbeat Intervention; Participants in this arm receive the mothers' heartbeat intervention in addition to usual phototherapy care. The intervention uses a multisensory Nucu Pad placed under the newborn's mattress. Each mother's heartbeat, breathing sounds and chest vibrations are recorded and transferred to the pad. During phototherapy, the newborn can hear and feel the mother's recorded heartbeat, breathing sounds and vibrations while lying on the mattress.	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.
No Intervention: Usual Phototherapy care; Participants in this arm receive usual phototherapy care only according to standard maternity ward practice. Phototherapy may be provided using a Bilisoft Blanket, overhead phototherapy lights or both, according to clinical need.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility, usability and acceptability of the mothers' heartbeat intervention	Feasibility, usability and acceptability of the mothers' heartbeat intervention are assessed among mothers in the intervention group using the System Usability Scale (SUS). The SUS includes 10 items rated on a 5-point Likert scale from "strongly disagree" to "strongly agree". The total SUS score ranges from 0 to 100, with higher scores indicating better usability and acceptability.	After completion of phototherapy, approximately 24 hours after the start of phototherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal anxiety	Maternal anxiety is assessed using the State-Trait Anxiety Inventory, state anxiety form (STAI-Y1). The measure includes 20 items assessing the mother's current anxiety. Scores range from 20 to 80, with higher scores indicating higher anxiety. Anxiety is classified as low, moderate or high according to the total score.	Baseline -Before phototherapy
Maternal stress	Maternal stress is assessed using a verbal rating scale for stress (VRSS). Mothers rate their stress on a 0-5 scale ranging from "I did not feel any stress at all" to "I felt the worst stress I can think of". Higher scores indicate higher perceived stress.	Baseline -Before phototherapy
Maternal experience of phototherapy	Mothers evaluate their overall experience of newborn phototherapy using a numerical rating scale (NRS) from 0 to 10, where 0 indicates a very negative experience and 10 indicates a very positive experience. Higher scores indicate a more positive phototherapy experience.	After completion of phototherapy, approximately 24 hours after the start of phototherapy
Maternal anxiety	Maternal anxiety is assessed using the State-Trait Anxiety Inventory, state anxiety form (STAI-Y1). The measure includes 20 items assessing the mother's current anxiety. Scores range from 20 to 80, with higher scores indicating higher anxiety. Anxiety is classified as low, moderate or high according to the total score.	After completion of phototherapy, approximately 24 hours after the start of phototherapy.
Maternal stress	Maternal stress is assessed using a verbal rating scale for stress (VRSS). Mothers rate their stress on a 0-5 scale ranging from "I did not feel any stress at all" to "I felt the worst stress I can think of". Higher scores indicate higher perceived stress.	After completion of phototherapy, approximately 24 hours after the start of phototherapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mothers' experiences of successful factors related to the intervention	Mothers in the intervention group participate in semi-structured interviews after newborn phototherapy. The interviews explore mothers' experiences of successful factors related to the mothers' heartbeat intervention, including perceived calming effects, user-friendliness and the role of the intervention as a facilitating element during phototherapy.	After completion of phototherapy, approximately 24 hours after the start of phototherapy

Collaborators and Investigators

• Sponsor: Mervi Hakala
• Collaborators: University of Oulu
• Investigators: Study Director: Tarja Pölkki, Professor, University of Oulu

Publications and helpful links

General Publications

• Whitehead AL, Julious SA, Cooper CL, Campbell MJ. Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.
• Teresi JA, Yu X, Stewart AL, Hays RD. Guidelines for Designing and Evaluating Feasibility Pilot Studies. Med Care. 2022 Jan 1;60(1):95-103. doi: 10.1097/MLR.0000000000001664.
• Zhang Q, Huo Q, Chen P, Yao W, Ni Z. Effects of white noise on preterm infants in the neonatal intensive care unit: A meta-analysis of randomised controlled trials. Nurs Open. 2024 Jan;11(1):e2094. doi: 10.1002/nop2.2094.
• van der Geest BAM, Theeuwen IM, Reiss IKM, Steegers EAP, Been JV. Assessing knowledge and skills of maternity care professionals regarding neonatal hyperbilirubinaemia: a nationwide survey. BMC Pregnancy Childbirth. 2021 Jan 19;21(1):63. doi: 10.1186/s12884-020-03463-0.
• Siva N, Praharaj M, Tanay K, Das S, Nayak BS, Lewis LES, Noronha JA. Evidenced-Based Recommendation for Involving Mothers to Reduce the Procedural Pain and Stress in High-Risk Neonates: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Adv Neonatal Care. 2025 Apr 1;25(2):103-112. doi: 10.1097/ANC.0000000000001247. Epub 2025 Mar 26.
• Sarker S, Jahan F, Parvez SM, Shoab AKM, Hasan R, El Arifeen S, Billah SM, Hoque MM, Rahman M. Effectiveness of prenatal intervention on neonatal hyperbilirubinemia management in rural Bangladesh: Results from a cluster-randomized trial. Public Health. 2025 Jan;238:221-228. doi: 10.1016/j.puhe.2024.12.018. Epub 2024 Dec 16.
• Pettersson M, Eriksson M, Odlind A, Ohlin A. Home phototherapy of term neonates improves parental bonding and stress: Findings from a randomised controlled trial. Acta Paediatr. 2022 Apr;111(4):760-766. doi: 10.1111/apa.16231. Epub 2021 Dec 28.
• Pettersson M, Eriksson M, Blomberg K. Parental experiences of home phototherapy for neonatal hyperbilirubinemia. J Child Health Care. 2023 Dec;27(4):562-573. doi: 10.1177/13674935221082404. Epub 2022 Mar 26.
• Pearson N, Naylor PJ, Ashe MC, Fernandez M, Yoong SL, Wolfenden L. Guidance for conducting feasibility and pilot studies for implementation trials. Pilot Feasibility Stud. 2020 Oct 31;6(1):167. doi: 10.1186/s40814-020-00634-w.
• Muchowski KE. Evaluation and treatment of neonatal hyperbilirubinemia. Am Fam Physician. 2014 Jun 1;89(11):873-8.
• Matvienko-Sikar K, Redsell S, Flannery C. Effects of maternal stress and/or anxiety interventions in the first 1000 days:Systematic review of reviews. J Reprod Infant Psychol. 2023 Apr;41(2):114-151. doi: 10.1080/02646838.2021.1976400. Epub 2021 Sep 23.
• Coquery SS, Georges A, Cortey A, Floch C, Avran D, Gatbois E, Mehler-Jacob C, de Stampa M. Discharge of newborns with risk factors of severe hyperbilirubinemia: description of a hospital at home-based care monitoring and phototherapy. Eur J Pediatr. 2022 Aug;181(8):3075-3084. doi: 10.1007/s00431-022-04461-4. Epub 2022 Jun 13.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2024
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 17, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 17, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: phototherapy; anxiety; stress; feasibility study; newborn; jaundice; experience; mother; mixed methods
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Hyperbilirubinemia; Skin Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Jaundice; Anxiety Disorders
• Other Study ID Numbers: EETTMK: 12/2024; 181/2024 (Registry Identifier: Pohteen tutkimusdiaarinumero)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared because the study includes a small sample of mothers and newborns and contains sensitive maternal and neonatal health-related data. The qualitative interview data may include contextual information that could increase the risk of participant identification, even after anonymization.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No