Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06047808
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2023-06-06
Brief Title:
Feasibility Study of the Storytelling Through Music Intervention With Bereaved Parents
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
A Feasibility Study Evaluating Storytelling Through Music Intervention With Bereaved Parents of Children With Cancer
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The death of a child at any age is considered one of the most stressful life events a person can experience In 2020 11050 children under 15 years 5000 adolescents 15-19 years and 60000 young adults 20-39 years were estimated to be diagnosed with cancer in the US While the five-year survival is better for children than adults over 10000 children adolescents and young adults die from cancer in the US each year1 Bereaved parents often experience intense and lasting psychological distress resulting in significantly higher morbidity and mortality compared to non-bereaved parents Twenty-five percent of bereaved parents report new diagnoses of illnesses including prediabetes anxiety and sleep disorders Bereaved parents also experience psychological distress such as anxiety post-traumatic stress disorder and grief-related depressive symptoms that continue to be significant for years after a childs death A recent study showed that nearly 33 of bereaved parents suffered from prolonged grief five years after their loss6 Physiologically studies show increased cortisol immune endocrine and cardio biomarkers in people with prolonged grief The death of a child can also affect family and social relationships resulting in decreased communication feelings of isolation absence of close social relationships and increased marital strain and divorce
The purpose of this randomized controlled pilot study is to evaluate the feasibility of implementing a six-week multi-dimensional intervention Storytelling Through Music STM with parents of children who have died from cancer STM combines multiple modalities of expression storytelling writing and music to facilitate loss- and restoration-oriented coping by creating a legacy piece self-written story paired with song to facilitate continuing bonds with the deceased and find meaning
The purpose of this randomized controlled pilot study is to evaluate the feasibility of implementing a six-week multi-dimensional intervention Storytelling Through Music STM with parents of children who have died from cancer STM combines multiple modalities of expression storytelling writing and music to facilitate loss- and restoration-oriented coping by creating a legacy piece self-written story paired with song to facilitate continuing bonds with the deceased and find meaning
Detailed Description:
The death of a child at any age is considered one of the most stressful life events a person can experience In 2020 11050 children under 15 years 5000 adolescents 15-19 years and 60000 young adults 20-39 years were estimated to be diagnosed with cancer in the US While the five-year survival is better for children than adults over 10000 children adolescents and young adults die from cancer in the US each year Bereaved parents often experience intense and lasting psychological distress resulting in significantly higher morbidity and mortality than non-bereaved parents Twenty-five percent of bereaved parents report new diagnoses of illnesses including prediabetes anxiety and sleep disorders Bereaved parents also experience psychological distress such as anxiety post-traumatic stress disorder and grief-related depressive symptoms that continue to be significant for years after a childs death A recent study showed that nearly 33 of bereaved parents suffered from prolonged grief five years after their loss Physiologically studies show increased cortisol immune endocrine and cardio biomarkers in people with prolonged grief The death of a child can also affect family and social relationships resulting in decreased communication feelings of isolation absence of close social relationships and increased marital strain and divorce
The World Health Organization and the National Coalition for Hospice and Palliative Care NCHPC advocate that palliative care should not only improve the quality of life of patients but also extend into bereavement for families The NCHPC bereavement guideline 751c states that bereavement interventions should include rituals that acknowledge loss and transition provide opportunities for remembrance and establish a sense of community Researchers have examined the use of life review dignity therapy and remembrance with pediatric and adolescent patients as well as bereaved family caregivers of spouses However to our knowledge none have been conducted with bereaved parents Despite the high risk of negative outcomes and national guidelines recommending bereavement care the resources for bereaved parents are scarce In a recent systematic review of intervention studies for bereaved parents only fifteen interventions were identified Of those studies most lacked empirical evidence of effectiveness or alignment with key theoretical concepts To increase the number of effective resources for this vulnerable and underserved population interventions need to be developed and tested in order to promote health and disease prevention in this high-risk population
Mechanisms of Coping with Parental Grief
Parental bereavement is complex because many personal relational and end-of-life circumstances affect bereavement and individuals cope differently Several factors are associated with prolonged grief and poorer psychosocial outcomes including intra-personal ie attachment style sex religious beliefs age history of mental health problems inter-personal ie social support family culture religious practice resources and the unexpectedness of the loss However none of these factors are easily changed by interventions Focusing on modifiable processes that mediate or moderate the adaptation trajectory in bereavement may be more beneficial In bereaved adults processes that mediate the relationship between risk factors and mental health outcomes include rumination deliberate grief avoidance emotional expression cognitive appraisals and meaning-making
Meta-Affective and Meta-Cognitive Effects of Grief
A growing body of research suggests that self-compassion is positively associated with well-being and negatively associated with depression anxiety and post-traumatic stress Self-compassion recognizes suffering as a universally shared human experience and teaches people to face their suffering non-judgmentally with a kind and mindful approach Only one study has examined the influence of self-compassion on grief processing showing a significant relationship between low self-compassion and the severity of complicated grief Self-compassion may be beneficial in coping with grief because it is associated with engagement in rather than avoidance of painful thoughts memories and feelings Furthermore research on meta-cognition has shown that maladaptive coping strategies such as rumination are driven by metacognitive appraisals of an internal or external event Meta-cognitive beliefs may keep bereaved people focused on loss issues preventing them from integrating the loss into their lives and planning for the future
Affective and Cognitive Effects of Expressive Arts
Expressive arts have been used to improve psychosocial well-being in people with cancer adolescents with grief veterans with post-traumatic stress disorder and to aid bereavement among family caregivers Yet many of these studies lack methodological rigor Interventions aimed at meaning-making are good for individuals at high risk for prolonged grief Music has been used across cultures and there is growing evidence that music is often more powerful than language alone in eliciting emotion is processed throughout spinal subcortical and cortical regions and thus has meaningful impacts on complex cognitive and affective processes While music and language utilize similar features in the brain music is more rooted in the primitive brain structures involved in motivation reward and emotion Within the brain emotional language and memory centers are connected during music processing
TheoreticalConceptual Framework
Two complementary models guide this study The Dual-Process Model of Coping with Bereavement and the Meaning Reconstruction Model Both models view grief as a life-long process of renegotiating continuing bonds with the deceased and finding meaning in life after the loss The dual-process model posits that grieving a loved one entails oscillating between orientation to the loss ie continuing bonds with the deceased by expressing emotion related to the death and reconnecting with the memory of the loved one and restoration of contact with a changed world ie re-engaging relationships and experimenting with new life roles The meaning reconstruction model of grief views grieving as a process of reaffirming or reforming a world of meaning that has been challenged by loss Research on these models demonstrates signs of efficacy particularly regarding how continuing bonds with the deceased and meaning-making are important mechanisms of successful adaption to bereavement
Preliminary Work
This team has implemented two pilot studies examining the in-person and online delivery of STM to professional caregivers In both studies the intervention delivery method was feasible and significant improvements were seen in coping self-compassion F3 105 288 p05 self-awareness F3 120 242 p10 psychosocial loneliness F3 98 746 p001 and functional insomnia F3 120 577 p001 well-being Qualitatively participants reported feeling less emotional loneliness and the stories and songs provided reflection and meaning-making An unexpected finding from this study was that 60 of participants in the intervention arm had experienced a significant family loss mostly to cancer that inspired their oncology nursing careers During the intervention this primary family loss with the grief they needed to examine This finding informed our team of the need for bereavement interventions for family caregivers
The World Health Organization and the National Coalition for Hospice and Palliative Care NCHPC advocate that palliative care should not only improve the quality of life of patients but also extend into bereavement for families The NCHPC bereavement guideline 751c states that bereavement interventions should include rituals that acknowledge loss and transition provide opportunities for remembrance and establish a sense of community Researchers have examined the use of life review dignity therapy and remembrance with pediatric and adolescent patients as well as bereaved family caregivers of spouses However to our knowledge none have been conducted with bereaved parents Despite the high risk of negative outcomes and national guidelines recommending bereavement care the resources for bereaved parents are scarce In a recent systematic review of intervention studies for bereaved parents only fifteen interventions were identified Of those studies most lacked empirical evidence of effectiveness or alignment with key theoretical concepts To increase the number of effective resources for this vulnerable and underserved population interventions need to be developed and tested in order to promote health and disease prevention in this high-risk population
Mechanisms of Coping with Parental Grief
Parental bereavement is complex because many personal relational and end-of-life circumstances affect bereavement and individuals cope differently Several factors are associated with prolonged grief and poorer psychosocial outcomes including intra-personal ie attachment style sex religious beliefs age history of mental health problems inter-personal ie social support family culture religious practice resources and the unexpectedness of the loss However none of these factors are easily changed by interventions Focusing on modifiable processes that mediate or moderate the adaptation trajectory in bereavement may be more beneficial In bereaved adults processes that mediate the relationship between risk factors and mental health outcomes include rumination deliberate grief avoidance emotional expression cognitive appraisals and meaning-making
Meta-Affective and Meta-Cognitive Effects of Grief
A growing body of research suggests that self-compassion is positively associated with well-being and negatively associated with depression anxiety and post-traumatic stress Self-compassion recognizes suffering as a universally shared human experience and teaches people to face their suffering non-judgmentally with a kind and mindful approach Only one study has examined the influence of self-compassion on grief processing showing a significant relationship between low self-compassion and the severity of complicated grief Self-compassion may be beneficial in coping with grief because it is associated with engagement in rather than avoidance of painful thoughts memories and feelings Furthermore research on meta-cognition has shown that maladaptive coping strategies such as rumination are driven by metacognitive appraisals of an internal or external event Meta-cognitive beliefs may keep bereaved people focused on loss issues preventing them from integrating the loss into their lives and planning for the future
Affective and Cognitive Effects of Expressive Arts
Expressive arts have been used to improve psychosocial well-being in people with cancer adolescents with grief veterans with post-traumatic stress disorder and to aid bereavement among family caregivers Yet many of these studies lack methodological rigor Interventions aimed at meaning-making are good for individuals at high risk for prolonged grief Music has been used across cultures and there is growing evidence that music is often more powerful than language alone in eliciting emotion is processed throughout spinal subcortical and cortical regions and thus has meaningful impacts on complex cognitive and affective processes While music and language utilize similar features in the brain music is more rooted in the primitive brain structures involved in motivation reward and emotion Within the brain emotional language and memory centers are connected during music processing
TheoreticalConceptual Framework
Two complementary models guide this study The Dual-Process Model of Coping with Bereavement and the Meaning Reconstruction Model Both models view grief as a life-long process of renegotiating continuing bonds with the deceased and finding meaning in life after the loss The dual-process model posits that grieving a loved one entails oscillating between orientation to the loss ie continuing bonds with the deceased by expressing emotion related to the death and reconnecting with the memory of the loved one and restoration of contact with a changed world ie re-engaging relationships and experimenting with new life roles The meaning reconstruction model of grief views grieving as a process of reaffirming or reforming a world of meaning that has been challenged by loss Research on these models demonstrates signs of efficacy particularly regarding how continuing bonds with the deceased and meaning-making are important mechanisms of successful adaption to bereavement
Preliminary Work
This team has implemented two pilot studies examining the in-person and online delivery of STM to professional caregivers In both studies the intervention delivery method was feasible and significant improvements were seen in coping self-compassion F3 105 288 p05 self-awareness F3 120 242 p10 psychosocial loneliness F3 98 746 p001 and functional insomnia F3 120 577 p001 well-being Qualitatively participants reported feeling less emotional loneliness and the stories and songs provided reflection and meaning-making An unexpected finding from this study was that 60 of participants in the intervention arm had experienced a significant family loss mostly to cancer that inspired their oncology nursing careers During the intervention this primary family loss with the grief they needed to examine This finding informed our team of the need for bereavement interventions for family caregivers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None