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.
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
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 group | Role | What they receive |
|---|---|---|
| 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. 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.
Number of participants who will give consent for participation
Number of participants who will give consent for participation
Measured: 1 year
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.
- First posted14 Feb 2024
- Study start7 Jan 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals, Leicester
- Responsible party
- Sponsor
- Investigators
- Shalini Ojha, Study director, University Hospitals of Derby and Burton NHS Trust
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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06259305
- Acronym / sponsor ID
- UHDB/2022/087S
- Conditions
- Palliative Care
- Keywords
- Palliative Care, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospitals of Derby and Burton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University Hospitals, Leicester
- Study start
- 7 Jan 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Observational,
| Arm | Type | Receives |
|---|---|---|
| Creation of a memory track combined with the baby's heartbeat | Experimental | Other: Creation of a memory track combined with the baby's heartbeatA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- · Pregnant people aged 18 and over
Key exclusion criteria (4 listed)
- · Pregnant people <18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creation of a memory track combined with the baby's heartbeatThis is as described above | Other | Creation of a memory track combined with the baby's heartbeat |
Primary outcome
Number of participants who will give consent for participation
Time frame: 1 year
Number of participants who will give consent for participation
Number of participants who complete music therapy
Time frame: 1 year
Number of participants who complete music therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: Yes. Data will be made available on reasonable request to the Chief Investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shalini Ojha study director
University Hospitals of Derby and Burton NHS Trust
1 site in 1 country: see every site and its status.
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.