Clinical trial NCT04775524: AWARENESS Trial (AWARENESS) of Storytelling Through Music in Healthcare Workers
Official title: An Arts-based Intervention With Healthcare Workers: Storytelling Through Music to Address Work Related Emotions (AWARENESS Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Post Traumatic Stress Disorder
Work Related Stress
Keywords: Stress
Post Traumatic Stress Disorder
Work Related Stress
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of intervention
timeFrame: 6 weeks
measure: Acceptability of intervention
timeFrame: 6 weeks
Secondary outcomes:
measure: Self-awareness
timeFrame: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
measure: Post-traumatic stress
timeFrame: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
measure: Self-compassion
timeFrame: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
measure: Anxiety
timeFrame: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
measure: Depression
timeFrame: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
measure: Insomnia
timeFrame: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
measure: Loneliness
timeFrame: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
measure: Post-traumatic growth
timeFrame: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
measure: Professional Quality of Life
timeFrame: 6 weeks (both groups), 11 weeks (both groups), 19weeks (intervention group only)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Carolyn Phillips, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: