Memories in Heartbeats Study

NCT06259305 | Completed

• 1 other identifier: UHDB/2022/087S
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

A small feasibility study to explore the role of music therapy as part of memory making experiences in mothers who are experiencing a pregnancy where screening tests show that the foetus has a condition meaning they may not develop to full term, survive the birth or that the new-born will have continued complications and limited life expectancy once born. The outcome of this study will be to determine the feasibility and acceptability of offering antenatal music therapy for families experiencing pregnancies where a foetal condition or anomaly means that comfort care only is planned for the baby after birth and to assess if the development of a musical memory-making tool will be relevant for this patient group within the current bereavement midwifery services. The study plans to use the recorded heartbeat of the unborn foetus and then to combine this with music of the family's choice to create a memory track which can then be saved into a recording device such as a memory bear for the family to keep. It is proposed that this intervention could complement current memory making processes already being offered by services such as bereavement midwives working within Hospital trusts.

Conditions

Palliative Care

Keywords

Palliative Care; Pregnancy

Outcome Measures

Primary Outcomes (2)

• Number of participants who will give consent for participation

  Number of participants who will give consent for participation

  1 year

• Number of participants who complete music therapy

  Number of participants who complete music therapy

  1 year

Study Arms (1)

Creation of a memory track combined with the baby's heartbeat

EXPERIMENTAL

A memory track will be created by the music therapist with the family and this will be overlaid with a recording of the baby's heartbeat, provided by the family. This recording will be placed inside a memory bear and given to the family to keep. This will be offered to form part of the memory making process alongside existing processes.

Other: Creation of a memory track combined with the baby's heartbeat

Interventions

Creation of a memory track combined with the baby's heartbeat OTHER

This is as described above

Creation of a memory track combined with the baby's heartbeat

Eligibility Criteria

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

You may qualify if:

• · Pregnant people aged 18 and over
• Experiencing a pregnancy where, due to a foetal diagnosis, the baby is unlikely to survive to full term or a comfort care only plan for postnatal care has been agreed between the parents and the health care professionals
• Subjects capable of giving informed consent
• Subjects have sufficient comprehension of the English language to enable informed consent
• Subjects have, or can get, a recording of their baby's heartbeat that they are willing to share with the PI for the purpose of the study

You may not qualify if:

• · Pregnant people \<18 years of age
• Lack of capacity to provide informed consent
• Have insufficient comprehension of the English Language to provide informed consent
• No recording of baby's heartbeat, and not able to get one, or not willing to share with the PI for the purpose of the study

Sponsors & Collaborators

• University Hospitals of Derby and Burton NHS Foundation Trust: lead
• University Hospitals, Leicester: collaborator

Study Sites (1)

Rainbows Hospice for Babies, Children and Young Adults Rainbows will be will be undertaking some of the core study coordination/management activities

Loughborough, LE112HS, United Kingdom

Location

Study Officials

• Shalini Ojha

  University Hospitals of Derby and Burton NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Observational,

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: February 14, 2024
• Study Start: January 7, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 27, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Available from end of study to 5 years
• Access Criteria: Data will be made available on reasonable request to the Chief Investigator. The data will be completely anonymised and de-identified in line with the study protocol.

Locations

GB (1)