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AWARENESS Trial (AWARENESS) of Storytelling Through Music in Healthcare Workers

An Arts-based Intervention With Healthcare Workers: Storytelling Through Music to Address Work Related Emotions (AWARENESS Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04775524
Enrollment
24
Registered
2021-03-01
Start date
2021-03-01
Completion date
2024-08-31
Last updated
2024-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder, Stress, Work Related Stress

Keywords

Stress, Post Traumatic Stress Disorder, Work Related Stress

Brief summary

This research study is examining the feasibility and effectiveness of an online version of the Storytelling Through Music (STM) program with oncology nurses who have worked during the COVID-19 pandemic.

Detailed description

This study employs a two-group, randomized controlled trial design that will utilize quantitative and qualitative methods to evaluate the feasibility and intervention effect of an alternative delivery (online) of the Storytelling Through Music program (STM). Previous study of In-person delivery of Storytelling Through Music program STM with oncology nurses found it to be feasible and beneficial to coping with stress and work-related emotions. The research study procedures include: screening for eligibility and study intervention including follow-up surveys. Participants will be randomized into two (2) groups: Storytelling Through Music (STM) and Waitlist (Storytelling Through Music-Hybrid) STM group: Participants are led through a writing workshop over an online platform (i.e., Zoom or an equivalent) to develop their story. Simultaneous with the writing sessions are 10-minute self-care lessons. At the end of the development workshop, each participant will be paired with a songwriter who will turn participant stories into songs. A final workshop will be held for participants to debrief about the emotional experience of participating in the Storytelling Through Music program (STM) Waitlist control group (Storytelling Through Music-Hybrid), will listen to songs created by healthcare workers in the Storytelling Through Music program (STM) for 2 weeks. Participation length will be based on the randomized group assignment, a total of 19 weeks for the STM group and 13 weeks for the waitlist group. It is expected that about 50 people will take part in this research study.

Interventions

BEHAVIORALStorytelling Through Music (STM)

6 week expressive arts-based program

BEHAVIORALWait List / Storytelling Through Music-Hybrid

2 week song listening program

Sponsors

Dana-Farber Cancer Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* The inclusion criteria for the study is as follows: a) \>18 years old; b) licensed oncology nurse; c) provided direct patient care during COVID-19 pandemic.

Exclusion criteria

* Key

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of intervention6 weeksPrimary endpoint is feasibility using visual analog scale Descriptive statistics will be used on the visual analog scale questions for analysis of feasibility. This intervention will be deemed feasible if 85% of the intervention is completed and 60% find it acceptable.
Acceptability of intervention6 weeksAdditional primary endpoint is acceptability using descriptive qualitative data. Open-ended questions will prompt participants to provide insights into quantitative findings and the acceptability of the intervention. This intervention will be deemed feasible if 85% of the intervention is completed and 60% find it acceptable.

Secondary

MeasureTime frameDescription
Self-compassion6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)Self-Compassion Scale; range is 26-130; higher score is better outcome.
Anxiety6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)PROMIS Anxiety Scale (Short-form 6); range is 5-30; lower score is better outcome.
Depression6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)PROMIS Depression Scale (Short-form 8); range is 8-40; lower score is better outcome.
Self-awareness6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)Self-Reflection and Insight Scale; range is 12-72; higher score means better outcome.
Loneliness6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)UCLA Loneliness Scale; range is 0-60; lower score is better outcome.
Post-traumatic growth6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)Post-Traumatic Growth Index; range is 0-105; lower score is better outcome.
Professional Quality of Life6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)Professional Quality of Life Scale; 3 separate subscale scores=burnout (range is 10-50; lower score equals better outcome); Secondary traumatic stress (range is 10-50; lower score equals better outcome); Compassion satisfaction (range is 10-50; higher score equals better outcome).
Insomnia6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)Insomnia Severity Index; range is 0-28; lower score is better outcome
Post-traumatic stress6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)Impact of Event Scale-Revised; range is 0-88; lower score is better outcome.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026