Longitudinal Study of Music Therapy's Effectiveness for Premature Infants and Their Caregivers
NCT ID: NCT03564184
Last Updated: 2022-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
213 participants
INTERVENTIONAL
2018-08-25
2022-08-31
Brief Summary
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Methods: Design: International multi-center, assessor-blind, 2x2 factorial, pragmatic randomized controlled trial. A feasibility study has been completed; ethical approval for the main trial is pending. Participants: 250 preterm infants and their parents. Intervention: MT focusing on singing specifically tailored to infant responses, will be delivered during NICU and/or during a post-discharge 6-month period. Primary outcome: Changes in mother-infant bonding until 6 months corrected age (CA), as measured by the Postpartum Bonding Questionnaire. Secondary outcomes: Mother-infant bonding at discharge and over 12 months CA; child development over 24 months; and parental depression, anxiety, and stress, and infant re-hospitalization, all over 12 months.
Discussion: This study fills a gap by measuring the long-term impact of MT for preterm infants/caregivers, and of MT beyond the hospital context. Outcomes related to highly involving parents in MT will directly inform the development of clinical practice in Scandinavia and other contexts with similar social welfare practices. By incorporating family-centered care, continuity of care, user involvement, and cultural relevance, this study can potentially contribute to improved quality of care for premature infants and their parents worldwide.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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MT during and after NICU
Consists of music therapy during NICU hospitalization, and music therapy after discharge from initial NICU hospitalization, along with standard care.
MT during NICU
Music therapy (MT) by trained music therapist, 3 times/week for 30-40 minutes/session during NICU hospitalization. Involves primary caregiver and infant in musical communication matched to infant post-menstrual age, family/cultural preferences, and infant readiness for stimulation. Music therapist assesses infant´s needs and behavior state, supports caregiver in using basic touch (e.g., hand lightly and statically on infant´s chest or back to perceive breathing pattern) and caregiver´s hummed/sung voice matched to infant behavioral responses, to promote infant state regulation and bonding. Music includes input from music therapist as needed, and multimodal aspects such as gentle dynamic touch when infant demonstrates readiness. MT may occur while infant is held in a static manner by caregiver or is resting in his/her isolette or basinet. MT may occur during skin-to-skin care, if such care is part of standard care.
MT after NICU
Music therapy offered by trained music therapist, 7 times for approximately 45 minutes/session across first 6 months following discharge from initial NICU hospitalization. Sessions include infant and caregiver, and siblings, if desired, and occur at home or in municipal settings. MT after NICU consists of a consult-to-parent model with each session including a brief verbal check-in regarding infant´s progress, musical interactions with music therapist modelling musical engagement, discussion of current challenges and strategies for using musical interactions to address needs in areas such as infant self-regulation, parent/infant interaction, and challenges with bonding. Caregivers will demonstrate techniques discussed during session, and form a brief plan for use of musical interaction in the interim before next session. Sessions will be adapted to infant developmental level and ongoing needs.
Standard care
Includes necessary medical care and standard supportive interventions offered as part of care during hospitalization, and standard follow-up procedures post-hospitalization.
MT during NICU
Consists of music therapy during NICU hospitalization, along with standard care.
MT during NICU
Music therapy (MT) by trained music therapist, 3 times/week for 30-40 minutes/session during NICU hospitalization. Involves primary caregiver and infant in musical communication matched to infant post-menstrual age, family/cultural preferences, and infant readiness for stimulation. Music therapist assesses infant´s needs and behavior state, supports caregiver in using basic touch (e.g., hand lightly and statically on infant´s chest or back to perceive breathing pattern) and caregiver´s hummed/sung voice matched to infant behavioral responses, to promote infant state regulation and bonding. Music includes input from music therapist as needed, and multimodal aspects such as gentle dynamic touch when infant demonstrates readiness. MT may occur while infant is held in a static manner by caregiver or is resting in his/her isolette or basinet. MT may occur during skin-to-skin care, if such care is part of standard care.
Standard care
Includes necessary medical care and standard supportive interventions offered as part of care during hospitalization, and standard follow-up procedures post-hospitalization.
MT after NICU
Consists of music therapy after discharge from initial NICU hospitalization, along with standard care.
MT after NICU
Music therapy offered by trained music therapist, 7 times for approximately 45 minutes/session across first 6 months following discharge from initial NICU hospitalization. Sessions include infant and caregiver, and siblings, if desired, and occur at home or in municipal settings. MT after NICU consists of a consult-to-parent model with each session including a brief verbal check-in regarding infant´s progress, musical interactions with music therapist modelling musical engagement, discussion of current challenges and strategies for using musical interactions to address needs in areas such as infant self-regulation, parent/infant interaction, and challenges with bonding. Caregivers will demonstrate techniques discussed during session, and form a brief plan for use of musical interaction in the interim before next session. Sessions will be adapted to infant developmental level and ongoing needs.
Standard care
Includes necessary medical care and standard supportive interventions offered as part of care during hospitalization, and standard follow-up procedures post-hospitalization.
No MT
Consists of standard care.
Standard care
Includes necessary medical care and standard supportive interventions offered as part of care during hospitalization, and standard follow-up procedures post-hospitalization.
Interventions
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MT during NICU
Music therapy (MT) by trained music therapist, 3 times/week for 30-40 minutes/session during NICU hospitalization. Involves primary caregiver and infant in musical communication matched to infant post-menstrual age, family/cultural preferences, and infant readiness for stimulation. Music therapist assesses infant´s needs and behavior state, supports caregiver in using basic touch (e.g., hand lightly and statically on infant´s chest or back to perceive breathing pattern) and caregiver´s hummed/sung voice matched to infant behavioral responses, to promote infant state regulation and bonding. Music includes input from music therapist as needed, and multimodal aspects such as gentle dynamic touch when infant demonstrates readiness. MT may occur while infant is held in a static manner by caregiver or is resting in his/her isolette or basinet. MT may occur during skin-to-skin care, if such care is part of standard care.
MT after NICU
Music therapy offered by trained music therapist, 7 times for approximately 45 minutes/session across first 6 months following discharge from initial NICU hospitalization. Sessions include infant and caregiver, and siblings, if desired, and occur at home or in municipal settings. MT after NICU consists of a consult-to-parent model with each session including a brief verbal check-in regarding infant´s progress, musical interactions with music therapist modelling musical engagement, discussion of current challenges and strategies for using musical interactions to address needs in areas such as infant self-regulation, parent/infant interaction, and challenges with bonding. Caregivers will demonstrate techniques discussed during session, and form a brief plan for use of musical interaction in the interim before next session. Sessions will be adapted to infant developmental level and ongoing needs.
Standard care
Includes necessary medical care and standard supportive interventions offered as part of care during hospitalization, and standard follow-up procedures post-hospitalization.
Eligibility Criteria
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Inclusion Criteria
* determined by medical staff to have achieved sufficient medical stability to start MT
* likely to be hospitalized longer than 2 weeks from time of recruitment
* willing to engage in at least 2 of 3 MT sessions per week during NICU and/or in 5 of 7 MT post-discharge sessions, if randomized to receive MT
* live with reasonable commuting distance from the treating NICU
* sufficient understanding of the respective national language(s) to answer questionnaires and participate in MT
Exclusion Criteria
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
University Hospital, Akershus
OTHER
Oslo University Hospital
OTHER
Meir Medical Center
OTHER
Clinica de La Mujer
OTHER
University of Haifa
OTHER
University of Gdansk
OTHER
King's College London
OTHER
Universidad de Ciencias Empresariales y Sociales
UNKNOWN
Szpital Miejski w Rudzie Śląskiej
UNKNOWN
SONO - Centro de Musicoterapia
UNKNOWN
Hospital Materno Infantil Ramón Sardá
NETWORK
Hospital Fernandez
OTHER
NORCE Norwegian Research Centre AS
OTHER
Responsible Party
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Christian Gold
Research Professor
Principal Investigators
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Christian Gold, PhD
Role: STUDY_CHAIR
NORCE Norwegian Research Centre
Claire Ghetti, PhD
Role: PRINCIPAL_INVESTIGATOR
Grieg Academy, University of Bergen
Locations
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Hospital Materno Infantil Ramón Sardá
Buenos Aires, Buenos Aires F.D., Argentina
Sanatorio Mater Dei
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Fernandez
Buenos Aires, , Argentina
Clinica de la Mujer
Bogotá, , Colombia
Fundación Santa Fe de Bogotá
Bogotá, , Colombia
Meir Medical Center
Kfar Saba, , Israel
Haukeland University Hospital, Barne-og ungdomsklinikken
Bergen, Hordaland, Norway
Akershus University Hospital
Oslo, Lørenskog, Norway
Oslo University Hospital, Rikshospitalet
Oslo, , Norway
Szpital Miejski w Rudzie Śląskiej
Ruda Śląska, , Poland
Countries
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References
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Bieleninik L, Ghetti C, Gold C. Music Therapy for Preterm Infants and Their Parents: A Meta-analysis. Pediatrics. 2016 Sep;138(3):e20160971. doi: 10.1542/peds.2016-0971. Epub 2016 Aug 25.
Ghetti C, Bieleninik L, Hysing M, Kvestad I, Assmus J, Romeo R, Ettenberger M, Arnon S, Vederhus BJ, Soderstrom Gaden T, Gold C. Longitudinal Study of music Therapy's Effectiveness for Premature infants and their caregivers (LongSTEP): protocol for an international randomised trial. BMJ Open. 2019 Sep 3;9(8):e025062. doi: 10.1136/bmjopen-2018-025062.
Bieleninik L, Kvestad I, Gold C, Stordal AS, Assmus J, Arnon S, Elefant C, Ettenberger M, Gaden TS, Haar-Shamir D, Havardstun T, Lichtensztejn M, Mangersnes J, Wiborg AN, Vederhus BJ, Ghetti CM. Music Therapy in Infancy and Neurodevelopmental Outcomes in Preterm Children: A Secondary Analysis of the LongSTEP Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2410721. doi: 10.1001/jamanetworkopen.2024.10721.
Ettenberger M, Bieleninik L, Stordal AS, Ghetti C. The effect of paternal anxiety on mother-infant bonding in neonatal intensive care. BMC Pregnancy Childbirth. 2024 Jan 11;24(1):55. doi: 10.1186/s12884-023-06179-z.
Ghetti CM, Gaden TS, Bieleninik L, Kvestad I, Assmus J, Stordal AS, Aristizabal Sanchez LF, Arnon S, Dulsrud J, Elefant C, Epstein S, Ettenberger M, Glosli H, Konieczna-Nowak L, Lichtensztejn M, Lindvall MW, Mangersnes J, Murcia Fernandez LD, Roed CJ, Saa G, Van Roy B, Vederhus BJ, Gold C. Effect of Music Therapy on Parent-Infant Bonding Among Infants Born Preterm: A Randomized Clinical Trial. JAMA Netw Open. 2023 May 1;6(5):e2315750. doi: 10.1001/jamanetworkopen.2023.15750.
Gaden TS, Gold C, Assmus J, Kvestad I, Stordal AS, Bieleninik L, Ghetti C. Treatment fidelity in a pragmatic clinical trial of music therapy for premature infants and their parents: the LongSTEP study. Trials. 2023 Mar 3;24(1):160. doi: 10.1186/s13063-022-06971-w.
Gaden TS, Ghetti C, Kvestad I, Bieleninik L, Stordal AS, Assmus J, Arnon S, Elefant C, Epstein S, Ettenberger M, Lichtensztejn M, Lindvall MW, Mangersnes J, Roed CJ, Vederhus BJ, Gold C. Short-term Music Therapy for Families With Preterm Infants: A Randomized Trial. Pediatrics. 2022 Feb 1;149(2):e2021052797. doi: 10.1542/peds.2021-052797.
Related Links
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Other Identifiers
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RCN 273534
Identifier Type: -
Identifier Source: org_study_id
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