- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07712978
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Oulu, Finland, 90220
- Oulu University Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
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.
|
|
Geen tussenkomst: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Feasibility, usability and acceptability of the mothers' heartbeat intervention
Tijdsspanne: After completion of phototherapy, approximately 24 hours after the start of phototherapy
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Maternal anxiety
Tijdsspanne: Baseline -Before phototherapy
|
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
Tijdsspanne: Baseline -Before phototherapy
|
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
Tijdsspanne: After completion of phototherapy, approximately 24 hours after the start 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
Tijdsspanne: After completion of phototherapy, approximately 24 hours after the start of phototherapy.
|
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
Tijdsspanne: After completion of phototherapy, approximately 24 hours after the start of phototherapy
|
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
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Mothers' experiences of successful factors related to the intervention
Tijdsspanne: After completion of phototherapy, approximately 24 hours after the start of phototherapy
|
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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Tarja Pölkki, Professor, University of Oulu
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EETTMK: 12/2024
- 181/2024 (Register-ID: Pohteen tutkimusdiaarinumero)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .