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

NCT07712978 | Completed

• 2 other identifiers: EETTMK: 12/2024181/2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Anxiety; Stress; Experience

Keywords

feasibility study; mixed methods; phototherapy; jaundice; newborn; stress; anxiety; experience; mother

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Maternal anxiety

  Baseline -Before phototherapy

• Maternal stress

  Baseline -Before phototherapy

• Maternal experience of phototherapy

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

• Maternal anxiety

  After completion of phototherapy, approximately 24 hours after the start of phototherapy.

• Maternal stress

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

Other Outcomes (1)

• Mothers' experiences of successful factors related to the intervention

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

Study Arms (2)

Mothers' Heartbeat Intervention

EXPERIMENTAL

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

Usual Phototherapy care

NO INTERVENTION

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.

Interventions

Mothers' Heartbeat Intervention DEVICE

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.

Mothers' Heartbeat Intervention

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mervi Hakala: lead
• University of Oulu: collaborator

Study Sites (1)

Oulu University Hospital

Oulu, 90220, Finland

Location

Related Publications (12)

• 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.

  PMID: 38268285 RESULT

• 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.

  PMID: 26092476 RESULT

• 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.

  PMID: 33468082 RESULT

• 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.

  PMID: 34812790 RESULT

• 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.

  PMID: 40048649 RESULT

• 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.

  PMID: 39689650 RESULT

• 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.

  PMID: 34932853 RESULT

• 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.

  PMID: 35341337 RESULT

• 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.

  PMID: 33292770 RESULT

• Muchowski KE. Evaluation and treatment of neonatal hyperbilirubinemia. Am Fam Physician. 2014 Jun 1;89(11):873-8.

  PMID: 25077393 RESULT

• 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.

  PMID: 34555958 RESULT

• 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.

  PMID: 35695955 RESULT

MeSH Terms

Conditions

Anxiety Disorders; Jaundice

Condition Hierarchy (Ancestors)

Mental Disorders; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Tarja Pölkki, Professor

  University of Oulu

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Arm 1: Mothers' Heartbeat Intervention Participants in this arm receive the mothers' heartbeat intervention in addition to usual phototherapy care. Arm 2: Usual Care Participants in this arm receive usual phototherapy care only. No masking was used. Participants, care providers and investigators were aware of group assignment because the mothers' heartbeat intervention involved recording the mother's heartbeat and using the Nucu Pad during newborn phototherapy.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Model Details: This is a non-randomized interventional feasibility study with a parallel assignment model. Participants were allocated to either an intervention group receiving the mothers' heartbeat intervention in addition to usual phototherapy care or a control group receiving usual phototherapy care only. Data were collected during two consecutive periods.

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 20, 2026
• Study Start: July 3, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)