AzTrials
AzTrials

Palliative CareNCT06259305

Memories in Heartbeats Study

A study testing Creation of a memory track combined with the baby's heartbeat in people with Palliative Care, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Palliative Care
What is being tested?
Creation of a memory track combined with the baby's heartbeat
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited Kingdom
Study dates
7 Jan 2024to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • · 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

Who cannot join

  • · 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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Rainbows Hospice for Babies, Children and Young Adults Rainbows will be will be undertaking some of the core study coordination/management activities

    Loughborough, LE112HS

Other trials in United Kingdom

About this study

Official title: Study of the Feasibility and Acceptability of Using Antenatal Music Therapy for Families Experiencing Pregnancies Where the Foetus Has a Life-Limiting Diagnosis

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.

Read the detailed description

It is evident from research that music, and in particular music therapy, can be hugely beneficial throughout pregnancy for both a mother and her developing baby (Lander, 2017; Arya et al, 2012). Communication, building relationships and relaxation are just some of the benefits experienced during the antenatal period and can be linked with postnatal experiences and development, in particular, within the Neonatal Intensive Care Units (NICUs) (Keith, Russell \& Weaver, 2009, Ettenberger, 2017, Roa \& Ettenberger, 2018).

However, comprehensive literature reveals little evidence about music therapy in pregnancies where screening tests show the foetus has a condition meaning they may not develop to full term, survive the birth or that the newborn will have ongoing complications and limited life expectancy. Having this knowledge and deciding to continue with the pregnancy undoubtedly has an impact on the antenatal bonding process and finding ways to connect with "the bump" are incredibly important (Mastnak, 2016).

This study proposes to explore the role music therapy can play in antenatal bonding and memory making experiences prior to birth. This uses recordings of the baby's heartbeat combined with precomposed music to create a memory track which can then be saved into a recording device such as a memory bear.

The study will involve a single recruiting site, the Rainbows Hospice for Babies, Children and Young Adults where the Principal Investigator (PI) is the music therapist who will undertake all the study procedures with the participants.

The two NHS Trusts (University Hospitals of Derby and Burton NHS Trust and Leicester University Hospitals) will be participant identification centres (PICs). Potential participants will be identified by the clinical staff delivering usual clinical care. They will then make the first approach and if the potential participant is interested, give them a Participant Information Sheet (PIS). The PIS will contain the contact details for the PI. The potential participant may contact the PI directly if they are interested in discussing the study further or participating.

Due to limited time available, the time between identification of the potential participant and consent may be short but there will be no pressure to make a decision. Participants will take as long as they wish to make this decision, in line with their clinical care and the usual clinical care and referral pathways will not be affected by this process.

If the potential participant wishes to participate, they will be invited to meet the PI, discuss any further questions about the study and will be asked to grant written informed consent. Following consent, minimal demographic and clinical information will be recorded and an appointment made to complete the intervention visit and this is the stage at which participants will be asked to share the recording of baby's heartbeat with the researcher. The visit will also include a discussion to understand what music, nursery rhyme, or other type of recording the family would like to use with the heartbeat. These will be facilitated by the PI who is an experienced music therapist. The music therapy intervention session will last between 1-2 hours and the part that will be used in the memory making will be audio recorded. The completed recording will be shared with the family and will be offered to the family in their preferred format such as being placed inside a "memory bear".

Following this, the participant will be invited to the post-intervention interview 6 months later. The interview will be offered as face to face but could be by telephone/web-based if the participant prefers. This will be a semi-structured interview, which will be audio-recorded, and will explore the acceptability of the intervention and the participant experience using a topic guide. If the participants want to know and have given written consent for it, the results of the study will be communicated to them.

Conditions
Palliative Care
Being tested
Creation of a memory track combined with the baby's heartbeat
Keywords
Palliative Care, Pregnancy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Creation of a memory track combined with the baby's heartbeatOther

    This is as described above

Study groups in NCT06259305
Study groupRoleWhat they receive
Creation of a memory track combined with the baby's heartbeatExperimentalA 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.
Receives: Other: Creation of a memory track combined with the baby's heartbeat

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who will give consent for participation

    Number of participants who will give consent for participation

    Measured: 1 year

  2. Number of participants who complete music therapy

    Number of participants who complete music therapy

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2024
  2. Study start7 Jan 2024
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
Observational,
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06259305
Sponsor's protocol ID
UHDB/2022/087S
Status last verified
Apr 2024
First submitted
23 Aug 2023
Last updated
27 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be made available on reasonable request to the Chief Investigator.

Questions about this trial

What is this clinical trial studying?

A study testing Creation of a memory track combined with the baby's heartbeat in people with Palliative Care, run by University Hospitals of Derby and Burton NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who will give consent for participation (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in