StressNCT06939426
Music Therapy and Humanization in ED Healthcare Professionals
A study testing Music therapy intervention in people with Stress and Burnout, run by Fundación Santa Fe de Bogota at 1 site in Colombia.
Trial summary
Background: Healthcare professionals in emergency departments frequently experience stressful situations that could jeopardize their mental health, sense of purpose, and ability to empathize with patients, families, and colleagues. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress, Burnout, Quality of Life (QOL)
- What is being tested?
- Music therapy intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteColombia
- Study dates
- 12 Jun 2025to 1 May 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Be a member of the emergency department nursing staff at the FSFB for a minimum of 6 months.
- Be able to commit to participating in eight music therapy sessions over a four-week period.
- Have the minimum reading skills to understand the questionnaires
Who cannot join
- Staff with untreated mental health disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Colombia1 site, 1 recruiting
- Recruiting
University Hospital Fundación Santa Fe de Bogotá
Bogotá, Bogota D.C., 1100121
Mark Ettenberger, P)hD, +573112847635, musicoterapia@fsfb.org.co
About this study
Official title: Impact of a Short Music Therapy Program on Intra- and Interpersonal Factors of Humanized Care in a Group of Emergency Nursing Staff at the University Hospital Fundación Santa Fe de Bogotá: a Mixed-methods Pilot and Feasibility Study
Background: Healthcare professionals in emergency departments frequently experience stressful situations that could jeopardize their mental health, sense of purpose, and ability to empathize with patients, families, and colleagues.
Research question: What is the impact of a short music therapy program on the intra- and interpersonal factors of humanized care among emergency nursing staff at the University Hospital Fundación Santa Fe de Bogotá (FSFB)? Methodology: This research is a mixed-methods pilot and feasibility study. For the quantitative component, we will apply the HUMAS (Healthcare Professional Humanization Scale) and ProQOL (Professional Quality of Life) measure at the start and at the end of the music therapy program. For the qualitative component, focus group interviews will be conducted and analyzed via thematic analysis.
Discussion: This study seeks to support the nursing staff of the FSFB emergency department through an interactive, creative, and participatory music therapy self-care program focused on one of the most important pillars of the institution: the humanization of care.
- Conditions
- Stress, Burnout, Quality of Life (QOL), Music Therapy, Humanization of Care
- Being tested
- Music therapy intervention
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapy interventionBehavioural
The intervention protocol is based on four main themes, which are addressed over the course of eight sessions:
- Self-care
- Self-recognition and expression of emotions
- Empathy
- Teamwork
Each theme is related to factors from the HUMAS (affection, self-efficacy, emotional understanding, dispositional optimism, and sociability) and/or ProQOL (compassion satisfaction, burnout, and compassion fatigue). A variety of techniques related to the four main methods of music therapy will be used in the sessions: receptive, re-creative, composition, and improvisation.
| Study group | Role | What they receive |
|---|---|---|
| Music therapy program | Experimental | Not described Receives: Behavioral: Music therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
HUMAS (Healthcare Professional Humanization Scale)
The HUMAS was developed by Pérez-Fuentes et al. and has been validated in Spanish among nursing professionals. It consists of 19 items evaluated on a 5-point Likert scale, with a total score ranging from 0 to 95, with higher scores indicating greater intra- and interpersonal skills that favor the humanization of the service provided. The items are divided into 5 factors: affection; self-efficacy: emotional understanding; disposition to optimism; sociability.
Measured: From enrollment to the end of the music therapy program after one month
Secondary outcomes (1)
ProQOL (Professional Quality of Life) measure
The ProQOL measure is one of the most widely used scales to determine quality of life in health professionals. It consists of 30 items rated retrospectively (over the past month) on a 5-point Likert scale. The scale measures the following factors: compassion satisfaction, burnout, and compassion fatigue. Each factor scores from 0 to 50, with higher scores indicating a greater satisfaction with an individual's work (compassion satisfaction) or higher scores indicating greater experience of fatigue, stress, or emotional exhaustion (compassion fatigue and burnout). The psychometric properties show satisfactory internal consistency and discriminant validity and it has been recently used in nursing teams in emergency units.
Measured: From enrollment to the end of the music therapy program after one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start12 Jun 2025
- Primary completion1 Dec 2025 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Santa Fe de Bogota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Ettenberger, Fundación Santa Fe de Bogota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939426
- Sponsor's protocol ID
- MTEMERGENCY01
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Short Music Therapy Program on Intra- and Interpersonal Factors of Humanized Care in a Group of Emergency Nursing Staff at the University Hospital Fundación Santa Fe de Bogotá: a Mixed-methods Pilot and Feasibility Study
- ClinicalTrials.gov ID
- NCT06939426
- Acronym / sponsor ID
- MTEMERGENCY01
- Conditions
- Stress, Burnout, Quality of Life (QOL), Music Therapy, Humanization of Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Fundación Santa Fe de BogotaUniversity, hospital or other
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 22 Apr 2025 (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.
Background: Healthcare professionals in emergency departments frequently experience stressful situations that could jeopardize their mental health, sense of purpose, and ability to empathize with patients, families, and colleagues.
Research question: What is the impact of a short music therapy program on the intra- and interpersonal factors of humanized care among emergency nursing staff at the University Hospital Fundación Santa Fe de Bogotá (FSFB)? Methodology: This research is a mixed-methods pilot and feasibility study. For the quantitative component, we will apply the HUMAS (Healthcare Professional Humanization Scale) and ProQOL (Professional Quality of Life) measure at the start and at the end of the music therapy program. For the qualitative component, focus group interviews will be conducted and analyzed via thematic analysis.
Discussion: This study seeks to support the nursing staff of the FSFB emergency department through an interactive, creative, and participatory music therapy self-care program focused on one of the most important pillars of the institution: the humanization of care.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music therapy program | Experimental | Behavioral: Music therapy intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Be a member of the emergency department nursing staff at the FSFB for a minimum of 6 months.
- Be able to commit to participating in eight music therapy sessions over a four-week period.
- Have the minimum reading skills to understand the questionnaires
Key exclusion criteria (1 listed)
- Staff with untreated mental health disorders.
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 interventionThe intervention protocol is based on four main themes, which are addressed over the course of eight sessions: * Self-care * Self-recognition and expression of emotions * Empathy * Teamwork Each theme is related to factors from the HUMAS (affection, self-efficacy, emotional understanding, dispositional optimism, and sociability) and/or ProQOL (compassion satisfaction, burnout, and compassion fatigue). A variety of techniques related to the four main methods of music therapy will be used in the sessions: receptive, re-creative, composition, and improvisation. | Behavioural | Music therapy program |
Primary outcome
HUMAS (Healthcare Professional Humanization Scale)
Time frame: From enrollment to the end of the music therapy program after one month
The HUMAS was developed by Pérez-Fuentes et al. and has been validated in Spanish among nursing professionals. It consists of 19 items evaluated on a 5-point Likert scale, with a total score ranging from 0 to 95, with higher scores indicating greater intra- and interpersonal skills that favor the humanization of the service provided. The items are divided into 5 factors: affection; self-efficacy: emotional understanding; disposition to optimism; sociability.
1 secondary outcome
ProQOL (Professional Quality of Life) measure
Time frame: From enrollment to the end of the music therapy program after one month
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 12 Aug 2025.
- Individual participant dataSharing planned: Yes. Data will be made available upon request.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy intervention in people with Stress and Burnout, run by Fundación Santa Fe de Bogota at 1 site in Colombia.
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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Mark Ettenberger, PhD (+573112847635, musicoterapia@fsfb.org.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HUMAS (Healthcare Professional Humanization Scale) (time frame: From enrollment to the end of the music therapy program after one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2025.