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NCT Number: NCT04775524

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

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.

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Key information

Conditions

Stress Behavior Behavioral Symptoms Mental Disorders Occupational Diseases Occupational Stress Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Stress, Psychological Trauma and Stressor Related Disorders Work Related Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 exclusion criteria include: a) have previously participated in the STM intervention.

Treatment and study plan

Storytelling Through Music (STM)

Behavioral

6 week expressive arts-based program

Wait List / Storytelling Through Music-Hybrid

Behavioral

2 week song listening program

Primary outcomes

  1. Feasibility of intervention

    Time frame: 6 weeks

    Primary 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.

  2. Acceptability of intervention

    Time frame: 6 weeks

    Additional 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 outcomes

  1. Self-awareness

    Time frame: 6 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.

  2. Post-traumatic stress

    Time frame: 6 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.

  3. Self-compassion

    Time frame: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)

    Self-Compassion Scale; range is 26-130; higher score is better outcome.

  4. Anxiety

    Time frame: 6 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.

  5. Depression

    Time frame: 6 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.

  6. Insomnia

    Time frame: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)

    Insomnia Severity Index; range is 0-28; lower score is better outcome

  7. Loneliness

    Time frame: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)

    UCLA Loneliness Scale; range is 0-60; lower score is better outcome.

  8. Post-traumatic growth

    Time frame: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)

    Post-Traumatic Growth Index; range is 0-105; lower score is better outcome.

  9. Professional Quality of Life

    Time frame: 6 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).

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 1, 2021
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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