PaediatricNCT07680348
Relational Music Therapy Procedural Support for Paediatric Patients and Families Facing Repeated Invasive Procedures
A study testing Music Therapy-Based Procedural Support (MTPS) in people with Paediatric and Invasive Procedure, run by Anglia Ruskin University.
Trial summary
This study explores how personalised music therapy can support children and their parents during repeated medical procedures, such as blood tests or injections. Many children find these procedures painful or frightening, and repeated experiences can lead to high anxiety and difficulty coping. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Paediatric, Invasive Procedure, Relation, Family
- What is being tested?
- Music Therapy-Based Procedural Support (MTPS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Paediatric patient (ages 5-12) undergoing recurring needle procedures (venipuncture, intravenous (IV) cannulation, subcutaneous injections, intramuscular (IM) injections, Port-a-Cath, lumbar punctures, and bone marrow transplant, aspiration or biopsy)
- Parents or caregiver of a paediatric patient (ages 5-12) undergoing recurring needle procedures.
- Willing to participate in music therapy-based sessions.
- Able to complete brief questionnaires and/or take part in an interview.
- Paediatric inpatient, outpatient, or palliative care unit.
Who cannot join
- Patients currently under heavy sedation or anaesthetic medication that impairs consciousness during data collection.
- Medically unstable or emergency care patients where participation may interfere with clinical care.
- Non-English or non-Norwegian speakers where language barriers may pose difficulties in participants understanding study information, and issues in interpretation and analysis of collected data.
- Patients with severe cognitive or developmental impairment making meaningful engagement with the intervention difficult.
- Severe behavioural/psychiatric conditions that will make safe participation difficult or impossible.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Relational Regulation: A Relational Approach to Music Therapy-based Procedural Support for Paediatric Patients and Families Facing Repeated Invasive Procedures
This study explores how personalised music therapy can support children and their parents during repeated medical procedures, such as blood tests or injections. Many children find these procedures painful or frightening, and repeated experiences can lead to high anxiety and difficulty coping. Parents often feel distressed as well, which can affect how well they are able to support their child. Because children and parents regulate each other emotionally, helping both members of the pair is important for reducing distress.
This study aims to explore how personalised music therapy-based procedural support (MTPS) influences the relational and emotional processes that help children and their parents cope, regulate, and build resilience during repeated medical procedures.
Read the detailed description
Background:
Repeated invasive procedures in paediatric healthcare settings, such as blood tests and injections, are frequently perceived as major stressors and can cause significant distress and anxiety in children. Procedural anxiety and acute distress often stems from prior medical trauma and can result in heightened pain perception, emotional dysregulation, and refusing, avoiding, or delaying healthcare later in life. This distress often extends to parents, who also report high levels of distress before and during medical procedures, affecting their ability to support their child. Studies show that low parental coping often leads to lower coping in the child and affects procedural experience and wellbeing. This suggests that child regulation and parental regulation during medical procedures are intertwined through attunement and synchrony. It also highlights the dyadic nature of coping and regulation, how parent regulation directly influences child regulation, and vice versa.
The study aims to answer these research questions:
- How does music therapy-based procedural support influence the parent-child connection, co-regulation, communication, and mutual support during medical procedures?
- How does repeated personalised music therapy-based procedural support influence emotional regulation, coping and resilience in children facing frequent medical procedures?
- How does music therapy-based procedural support influence parental perception of involvement, agency, and competence during their child's medical procedures?
- How do changes in parental agency, competency, and co-regulation relate to observed outcomes in the child's coping, resilience, and regulation?
Study design:
The study uses a qualitative-dominant mixed-methods multiple case series design with repeated measures. Between 5 and 10 parent-child dyads undergoing repeated needle-based procedures in an in-patient setting will participate. Participants will include children aged 5-12 years, alongside a parent or primary caregiver. Participants will receive personalised music therapy-based procedural support delivered by the researcher, a qualified music therapist. The intervention includes two to five preparatory sessions for initial meeting, introduction and familiarisation with the music therapy intervention, and planning and preparation for procedures. It will also include two or more music-supported medical procedures. Data will be collected at three key time points: (1) baseline, (2) during intervention, and (3) post-intervention. Data will be collected using a combination of qualitative and quantitative methods, including semi-structured interview with parents/primary caregiver, and arts-based sessions with children, researcher-therapist observational notes, structured observational measures, and brief questionnaires assessing parental sense of competence, child anxiety and distress, and parent-child relational interaction.
All qualitative data within each case will be analysed using narrative and reflexive thematic analysis. All quantitative outcome measures will be used descriptively to support the interpretation of patterns within and across the cases. If relevant, plans for inferential analysis will be further discussed with supervisory team and statistician. A cross-case synthesis will be conducted, identifying recurring themes across cases, linking any parent-child relational processes to observed behavioural and emotional outcomes.
- Conditions
- Paediatric, Invasive Procedure, Relation, Family, Music Therapy, Procedural Fear
- Being tested
- Music Therapy-Based Procedural Support (MTPS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music Therapy-Based Procedural Support (MTPS)Behavioural
Each participating dyad will take part in 2-5 preparatory music therapy sessions to familiarise them with the MTPS intervention. These sessions:
- Introduce the child and parent to personalised music-based strategies.
- Help the therapist understand what kinds of sounds, rhythms, or musical approaches help the child feel safe and regulated.
- Give the parent tools to support their child's coping.
During two or more of the child's routine medical procedures, the music therapist will be present to provide real-time music therapy-based support. This may include singing, rhythmic grounding, breathing with music, or familiar musical elements chosen with the family.
The intervention is tailored to each child and family and aims to support emotional regulation, coping, and parent-child co-regulation during repeated invasive procedures.
| Study group | Role | What they receive |
|---|---|---|
| Music Therapy-Based Procedural Support (MTPS) | Experimental | Participants (5-10 parent-child dyads) will receive personalised music therapy-based procedural support (MTPS), delivered by the researcher (a qualified music therapist). The intervention includes 2-5 preparatory music therapy sessions and music-supported assistance during two or more medical procedures. The intervention is tailored to each child and family and aims to support emotional regulation, coping, and parent-child co-regulation during repeated invasive procedures. Receives: Behavioral: Music Therapy-Based Procedural Support (MTPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent-child relational co-regulation and interaction
Primary outcome measures in this study are relational and emotional co-regulation and interaction between parent and child. These will be assessed using a study-specific structured observational framework, informed by attachment theory and the Emotional Availability conceptual framework (Biringen).
Observations will be recorded through researcher-therapist field notes and brief structured post-session reflections completed immediately following each session, capturing:
- parent attunement and responsiveness
- child emotional regulation and distress expression
- dyadic synchrony and interaction patterns
- key co-regulation and rupture-repair moments
- the role of music therapy in relational processes
Observational findings will be analysed qualitatively and triangulated with parent interviews, child arts-based data, and field notes, to provide a comprehensive understanding of relational processes.
Measured: From enrolment to the end of intervention period at 20 weeks
Secondary outcomes (5)
Parental sense of competence
Parent-reported sense of competence and confidence in supporting their child, measured using the Parenting Sense of Competence Scale-Revised (PSOC-R). Scores are rated on a 6-point scale with possible range 16-96, where 74-96 = high self-confidence, 61-73 = moderate self-confidence, and 16-60 = low self-confidence.
Measured: From enrolment until end of intervention period at 20 weeks
Child anxiety and procedural distress
Child self-reported anxiety/distress related to medical procedures, measured using the Faces Anxiety Scale. Scores are recorded using an ordinal scale of facial expressions representing increasing anxiety, with higher scores indicating greater anxiety/distress.
Measured: From enrolment until end of intervention period at 20 weeks
Child emotional state
Child self-reported emotional experience during medical procedures, assessed using the Blob Tree visual scale. The child select figures that best represent their emotional state and experience, with responses interpreted qualitatively and, where appropriate, categorised into ordinal groups.
Measured: From enrolment until end of intervention period at 20 weeks
Child perception of relational support and co-regulation
Child self-reported experience of relational support and co-regulation with their parent during procedures, assessed using a brief, developmentally adapted measure informed by the Security Scale. The measure consists of simple, age-appropriate questions with responses recorded using an ordinal visual scale of facial expressions representing decreasing agreement with the question statement, with higher scores indicating greater sense of relational support and co-regulation.
Measured: From enrolment until end of intervention period at 20 weeks
Child coping and adaptation
Child coping strategies and adaptive responses to repeated medical procedures, assessed through qualitative analysis of parent interviews, child arts-based sessions, and researcher-therapist field notes.
Measured: From enrolment until end of intervention period at 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for PaediatricStudies 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anglia Ruskin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680348
- Sponsor's protocol ID
- ETH2526-2528
- Status last verified
- Jun 2026
- First submitted
- 8 Jun 2026
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to small sample size and the qualitative, relational nature of the data, there is a risk of indirect identification of participants even after anonymisation. The dataset includes information from a vulnerable paediatric population. Findings will be shared in aggregated and fully anonymised form through publications and doctoral thesis.
Publications
Gjems, S., & Diseth, T. H. (2011). Forebygging og behandling av psykologiske traumer hos somatisk syke barn. Tidsskrift for Norsk psykologforening (trykt utg.), 48(9).
Silberstein, A. K., Ligård, E., Edlund, S. M., & Ullsten, A. (2024). Family-centered Music Therapy as Procedural Support in the Pediatric Outpatient Unit: A Mixed Methods Pilot Study. Music & Science, 7, 20592043231225734. https://doi.org/10.1177/20592043231225734
Brown EA, De Young A, Kimble R, Kenardy J. Impact of Parental Acute Psychological Distress on Young Child Pain-Related Behavior Through Differences in Parenting Behavior During Pediatric Burn Wound Care. J Clin Psychol Med Settings. 2019 Dec;26(4):516-529. doi: 10.1007/s10880-018-9596-1.
PubMed 30610521Feldman R. Parent-infant synchrony and the construction of shared timing; physiological precursors, developmental outcomes, and risk conditions. J Child Psychol Psychiatry. 2007 Mar-Apr;48(3-4):329-54. doi: 10.1111/j.1469-7610.2006.01701.x.
PubMed 17355401Gao Y, Xu Y, Liu N, Fan L. Effectiveness of virtual reality intervention on reducing the pain, anxiety and fear of needle-related procedures in paediatric patients: A systematic review and meta-analysis. J Adv Nurs. 2023 Jan;79(1):15-30. doi: 10.1111/jan.15473. Epub 2022 Nov 3.
PubMed 36330583Kimball H, Cobham VE, Sanders M, Douglas T. Procedural anxiety among children and adolescents with cystic fibrosis and their parents. Pediatr Pulmonol. 2023 Jul;58(7):1967-1976. doi: 10.1002/ppul.26419. Epub 2023 Apr 25.
PubMed 37097054Lakey B, Orehek E. Relational regulation theory: a new approach to explain the link between perceived social support and mental health. Psychol Rev. 2011 Jul;118(3):482-95. doi: 10.1037/a0023477.
PubMed 21534704Robertson EG, Kelada L, Ilin R, Palmer EE, Bye A, Jaffe A, Kennedy SE, Ooi CY, Drew D, Wakefield CE. Psychological wellbeing among parents of a child living with a serious chronic illness: A cross-sectional survey study. J Child Health Care. 2025 Sep;29(3):626-641. doi: 10.1177/13674935241238485. Epub 2024 Mar 29.
PubMed 38551845Wray J, Lee K, Dearmun N, Franck L. Parental anxiety and stress during children's hospitalisation: the StayClose study. J Child Health Care. 2011 Sep;15(3):163-74. doi: 10.1177/1367493511408632.
PubMed 21917594Yinger OS. Music Therapy as Procedural Support for Young Children Undergoing Immunizations: A Randomized Controlled Study. J Music Ther. 2016 Winter;53(4):336-363. doi: 10.1093/jmt/thw010. Epub 2016 Aug 17.
PubMed 27535171
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relational Regulation: A Relational Approach to Music Therapy-based Procedural Support for Paediatric Patients and Families Facing Repeated Invasive Procedures
- ClinicalTrials.gov ID
- NCT07680348
- Acronym / sponsor ID
- ETH2526-2528
- Conditions
- Paediatric, Invasive Procedure, Relation, Family, Music Therapy, Procedural Fear
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Anglia Ruskin UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 2 Jul 2026 (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.
This study explores how personalised music therapy can support children and their parents during repeated medical procedures, such as blood tests or injections. Many children find these procedures painful or frightening, and repeated experiences can lead to high anxiety and difficulty coping. Parents often feel distressed as well, which can affect how well they are able to support their child. Because children and parents regulate each other emotionally, helping both members of the pair is important for reducing distress.
This study aims to explore how personalised music therapy-based procedural support (MTPS) influences the relational and emotional processes that help children and their parents cope, regulate, and build resilience during repeated medical procedures.
Detailed description
Background:
Repeated invasive procedures in paediatric healthcare settings, such as blood tests and injections, are frequently perceived as major stressors and can cause significant distress and anxiety in children. Procedural anxiety and acute distress often stems from prior medical trauma and can result in heightened pain perception, emotional dysregulation, and refusing, avoiding, or delaying healthcare later in life. This distress often extends to parents, who also report high levels of distress before and during medical procedures, affecting their ability to support their child. Studies show that low parental coping often leads to lower coping in the child and affects procedural experience and wellbeing. This suggests that child regulation and parental regulation during medical procedures are intertwined through attunement and synchrony. It also highlights the dyadic nature of coping and regulation, how parent regulation directly influences child regulation, and vice versa.
The study aims to answer these research questions:
- How does music therapy-based procedural support influence the parent-child connection, co-regulation, communication, and mutual support during medical procedures?
- How does repeated personalised music therapy-based procedural support influence emotional regulation, coping and resilience in children facing frequent medical procedures?
- How does music therapy-based procedural support influence parental perception of involvement, agency, and competence during their child's medical procedures?
- How do changes in parental agency, competency, and co-regulation relate to observed outcomes in the child's coping, resilience, and regulation?
Study design:
The study uses a qualitative-dominant mixed-methods multiple case series design with repeated measures. Between 5 and 10 parent-child dyads undergoing repeated needle-based procedures in an in-patient setting will participate. Participants will include children aged 5-12 years, alongside a parent or primary caregiver. Participants will receive personalised music therapy-based procedural support delivered by the researcher, a qualified music therapist. The intervention includes two to five preparatory sessions for initial meeting, introduction and familiarisation with the music therapy intervention, and planning and preparation for procedures. It will also include two or more music-supported medical procedures. Data will be collected at three key time points: (1) baseline, (2) during intervention, and (3) post-intervention. Data will be collected using a combination of qualitative and quantitative methods, including semi-structured interview with parents/primary caregiver, and arts-based sessions with children, researcher-therapist observational notes, structured observational measures, and brief questionnaires assessing parental sense of competence, child anxiety and distress, and parent-child relational interaction.
All qualitative data within each case will be analysed using narrative and reflexive thematic analysis. All quantitative outcome measures will be used descriptively to support the interpretation of patterns within and across the cases. If relevant, plans for inferential analysis will be further discussed with supervisory team and statistician. A cross-case synthesis will be conducted, identifying recurring themes across cases, linking any parent-child relational processes to observed behavioural and emotional outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music Therapy-Based Procedural Support (MTPS) | Experimental | Behavioral: Music Therapy-Based Procedural Support (MTPS)Participants (5-10 parent-child dyads) will receive personalised music therapy-based procedural support (MTPS), delivered by the researcher (a qualified music therapist). The intervention includes 2-5 preparatory music therapy sessions and music-supported assistance during two or more medical procedures. The intervention is tailored to each child and family and aims to support emotional regulation, coping, and parent-child co-regulation during repeated invasive procedures. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Paediatric patient (ages 5-12) undergoing recurring needle procedures (venipuncture, intravenous (IV) cannulation, subcutaneous injections, intramuscular (IM) injections, Port-a-Cath, lumbar punctures, and bone marrow transplant, aspiration or biopsy)
- Parents or caregiver of a paediatric patient (ages 5-12) undergoing recurring needle procedures.
- Willing to participate in music therapy-based sessions.
- Able to complete brief questionnaires and/or take part in an interview.
- Paediatric inpatient, outpatient, or palliative care unit.
Key exclusion criteria (5 listed)
- Patients currently under heavy sedation or anaesthetic medication that impairs consciousness during data collection.
- Medically unstable or emergency care patients where participation may interfere with clinical care.
- Non-English or non-Norwegian speakers where language barriers may pose difficulties in participants understanding study information, and issues in interpretation and analysis of collected data.
- Patients with severe cognitive or developmental impairment making meaningful engagement with the intervention difficult.
- Severe behavioural/psychiatric conditions that will make safe participation difficult or impossible.
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 |
|---|---|---|
| Music Therapy-Based Procedural Support (MTPS)Each participating dyad will take part in 2-5 preparatory music therapy sessions to familiarise them with the MTPS intervention. These sessions: * Introduce the child and parent to personalised music-based strategies. * Help the therapist understand what kinds of sounds, rhythms, or musical approaches help the child feel safe and regulated. * Give the parent tools to support their child's coping. During two or more of the child's routine medical procedures, the music therapist will be present to provide real-time music therapy-based support. This may include singing, rhythmic grounding, breathing with music, or familiar musical elements chosen with the family. The intervention is tailored to each child and family and aims to support emotional regulation, coping, and parent-child co-regulation during repeated invasive procedures. | Behavioural | Music Therapy-Based Procedural Support (MTPS) |
Primary outcome
Parent-child relational co-regulation and interaction
Time frame: From enrolment to the end of intervention period at 20 weeks
Primary outcome measures in this study are relational and emotional co-regulation and interaction between parent and child. These will be assessed using a study-specific structured observational framework, informed by attachment theory and the Emotional Availability conceptual framework (Biringen). Observations will be recorded through researcher-therapist field notes and brief structured post-session reflections completed immediately following each session, capturing: * parent attunement and responsiveness * child emotional regulation and distress expression * dyadic synchrony and interaction patterns * key co-regulation and rupture-repair moments * the role of music therapy in relational processes Observational findings will be analysed qualitatively and triangulated with parent interviews, child arts-based data, and field notes, to provide a comprehensive understanding of relational processes.
5 secondary outcomes
Parental sense of competence
Time frame: From enrolment until end of intervention period at 20 weeks
Child anxiety and procedural distress
Time frame: From enrolment until end of intervention period at 20 weeks
Child emotional state
Time frame: From enrolment until end of intervention period at 20 weeks
Child perception of relational support and co-regulation
Time frame: From enrolment until end of intervention period at 20 weeks
Child coping and adaptation
Time frame: From enrolment until end of intervention period at 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- BackgroundGjems, S., & Diseth, T. H. (2011). Forebygging og behandling av psykologiske traumer hos somatisk syke barn. Tidsskrift for Norsk psykologforening (trykt utg.), 48(9).
- BackgroundSilberstein, A. K., Ligård, E., Edlund, S. M., & Ullsten, A. (2024). Family-centered Music Therapy as Procedural Support in the Pediatric Outpatient Unit: A Mixed Methods Pilot Study. Music & Science, 7, 20592043231225734. https://doi.org/10.1177/20592043231225734
- Background: PubMed 30610521Brown EA, De Young A, Kimble R, Kenardy J. Impact of Parental Acute Psychological Distress on Young Child Pain-Related Behavior Through Differences in Parenting Behavior During Pediatric Burn Wound Care. J Clin Psychol Med Settings. 2019 Dec;26(4):516-529. doi: 10.1007/s10880-018-9596-1.
- Background: PubMed 17355401Feldman R. Parent-infant synchrony and the construction of shared timing; physiological precursors, developmental outcomes, and risk conditions. J Child Psychol Psychiatry. 2007 Mar-Apr;48(3-4):329-54. doi: 10.1111/j.1469-7610.2006.01701.x.
- Background: PubMed 36330583Gao Y, Xu Y, Liu N, Fan L. Effectiveness of virtual reality intervention on reducing the pain, anxiety and fear of needle-related procedures in paediatric patients: A systematic review and meta-analysis. J Adv Nurs. 2023 Jan;79(1):15-30. doi: 10.1111/jan.15473. Epub 2022 Nov 3.
- Background: PubMed 37097054Kimball H, Cobham VE, Sanders M, Douglas T. Procedural anxiety among children and adolescents with cystic fibrosis and their parents. Pediatr Pulmonol. 2023 Jul;58(7):1967-1976. doi: 10.1002/ppul.26419. Epub 2023 Apr 25.
- Background: PubMed 21534704Lakey B, Orehek E. Relational regulation theory: a new approach to explain the link between perceived social support and mental health. Psychol Rev. 2011 Jul;118(3):482-95. doi: 10.1037/a0023477.
- Background: PubMed 38551845Robertson EG, Kelada L, Ilin R, Palmer EE, Bye A, Jaffe A, Kennedy SE, Ooi CY, Drew D, Wakefield CE. Psychological wellbeing among parents of a child living with a serious chronic illness: A cross-sectional survey study. J Child Health Care. 2025 Sep;29(3):626-641. doi: 10.1177/13674935241238485. Epub 2024 Mar 29.
- Background: PubMed 21917594Wray J, Lee K, Dearmun N, Franck L. Parental anxiety and stress during children's hospitalisation: the StayClose study. J Child Health Care. 2011 Sep;15(3):163-74. doi: 10.1177/1367493511408632.
- Background: PubMed 27535171Yinger OS. Music Therapy as Procedural Support for Young Children Undergoing Immunizations: A Randomized Controlled Study. J Music Ther. 2016 Winter;53(4):336-363. doi: 10.1093/jmt/thw010. Epub 2016 Aug 17.
- Individual participant dataSharing planned: No. Due to small sample size and the qualitative, relational nature of the data, there is a risk of indirect identification of participants even after anonymisation. The dataset includes information from a vulnerable paediatric population. Findings will be shared in aggregated and fully anonymised form through publications and doctoral thesis.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Music Therapy-Based Procedural Support (MTPS) in people with Paediatric and Invasive Procedure, run by Anglia Ruskin University.
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 5 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: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nina-Sofie T Halvorsen, MA Music Therapy (+4407907361997, nth108@prg.aru.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent-child relational co-regulation and interaction (time frame: From enrolment to the end of intervention period at 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07680348, which also lists 10 linked publications.
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 2 Jul 2026.