AnxietyNCT06510153
Music Therapy and Pre-recorded Music on Patients and Caregivers in the Emergency Unit
A study testing Environmental Music Therapy and Pre-recorded music in people with Anxiety and Stress, run by Claudia Aristizábal at 2 sites in Colombia.
Trial summary
Patients and caregivers attending emergency units often experience elevated levels of stress and anxiety. Music has been used in waiting rooms to reduce stress and anxiety, but existing studies on music in emergency unit waiting areas are scarce and have limitations such as low statistical power and limited music… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Stress, Well-Being, Psychological
- What is being tested?
- Environmental Music Therapy and Pre-recorded music
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 243 participants
- Where
- 2 sitesColombia
- Study dates
- 31 Jul 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients and caregivers/companions of legal age present in the emergency waiting room present during the intervention and control conditions.
- Patients whose triage does not represent immediate threat to life or severely ill patients (i.e., triage 3, 4 and 5)
- Patients and caregivers/companions with literacy skills.
Who cannot join
- Patients and caregivers/companions who report having hearing problems
- Patients and caregivers/companions with difficulties in understanding and/or filling out the questionnaires.
- Patients and/or caregivers/companions who do not consent to participate in the study.
Trial locations and contacts
2 sites in 1 country.
Colombia2 sites, 2 recruiting
- Recruiting
Clínica Iberoamérica
Barranquilla, Atlántico
Mark Ettenberger, PhD, +57 311 2847635, mark.ettenberger@gmx.at
Ana Diaz
- Recruiting
Clínica Keralty Ibagué
Ibague, Tolima Department
Mark Ettenberger, PhD, +57 311 2847635, mark.ettenberger@gmx.at
Angélica Hernandez, MSc
About this study
Official title: Effect of Live Environmental Music Therapy and Pre-recorded Music on State-Anxiety, Stress, Pain, and Wellbeing Levels of Patients and Caregivers in the Emergency Unit Waiting Area: A Multi-Center Randomized Clinical Trial Study Protocol
Patients and caregivers attending emergency units often experience elevated levels of stress and anxiety. Music has been used in waiting rooms to reduce stress and anxiety, but existing studies on music in emergency unit waiting areas are scarce and have limitations such as low statistical power and limited music selection. The aim of this study is to determine the effect of live Environmental Music Therapy (EMT) and pre-recorded music on state-anxiety, stress, pain and well-being levels in patients and caregivers in the emergency unit waiting areas of two hospitals in Colombia.
This study is a multi-center randomized clinical trial, with three arms: standard care + live EMT, standard care + pre-recorded music, and standard care only. The primary outcome measure is the six-item State-Trait Anxiety Inventory (STAI-6). Secondary outcome measures are pain and stress levels, both measured with a Visual Analogue Scales (VAS), and well-being, measured with the Well-Being Numerical Rating Scales (WB-NRSs). The scales will be applied before and after each intervention.
This study seeks to contribute to improving mental health, wellbeing, and quality of care of patients and caregivers in the waiting area of the emergency units. This is the first study in Colombia investigating the effect live music therapy and pre-recorded music interventions in the emergency department.
Read the detailed description
Main objective:
To determine the effect of standard care+ EMT or pre-recorded music on the state-anxiety, stress, pain, and wellbeing levels of anxiety-state, stress, pain, and well-being in adult patients and in the emergency waiting rooms of the Clínica Keralty Ibagué and Clínica Iberoamérica as compared to standard care alone.
Secondary objectives:
- Compare the sociodemographic and clinical characteristics of study participants according to the assigned intervention group.
- Evaluate the effect of EMT and pre-recorded music compared to the control group on state anxiety, stress, and wellbeing levels in adult patients and caregivers/companions in the emergency waiting rooms.
- Evaluate the effect of EMT and pre-recorded music compared to the control group on pain levels in patients in the emergency waiting rooms.
- Determine the variables that modify the effect of the interventions on primary and secondary outcomes in adult patients and their caregivers/companions in the emergency waiting rooms.
Methods Study Design
This study is a ramdomized clinical trial, multi-center, and pragmatic with three parallel arms - open label:
- Intervention Group 1 (GI1): Standard care + EMT
- Intervention Group 2 (GI2): Standard care + pre-recorded music
- Control Group (CG): Standard care alone
Study participants Study participants are adult patients and caregivers/companions in the emergency waiting room of both hospitals.
Concealment The concealment of the random assignment will be guaranteed using sealed, sequentially numbered, and opaque envelopes. The carbon paper inside the envelope will transfer the details of the random number and the group to which it is assigned (A, B or C). The envelopes will be sealed with tamper-proof security tape and opened sequentially on each day of intervention. The envelopes will be kept in a folder that will be kept on a locked shelf inside each clinic, which will be in custody by the research assistant at each participating clinic. The envelope will be opened 10 minutes before the start of the intervention to give the music therapists time to organize their equipment and instruments.
- Conditions
- Anxiety, Stress, Well-Being, Psychological
- Being tested
- Environmental Music Therapy, Pre-recorded music, Standard care only
- Keywords
- Music Therapy, Recorded Music, Anxiety, Stress, Wellbeing, Emergency Care, Waiting Room
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental Music TherapyOther
The music will consist of improvised music at a slow to moderate tempo, using free-flowing melodies, and simple chord progressions, focusing on creating moments of tension and resolution during approximately 20 minutes.
Pre-recorded musicOther
The protocol for pre-recorded music is the same as for EMT.
Standard care onlyOther
Standard care in the emergency room waiting room as provided by each hospital without being exposed to EMT or pre-recorded music.
| Study group | Role | What they receive |
|---|---|---|
| Environmental Music Therapy | Experimental | Environmental Music Therapy (EMT) is a music therapy technique that uses live music to modulate the potentially stressful effects of the environment towards an atmosphere that provides a sense of comfort and security. The instruments used will be an acoustic guitar (Yamaha C-40), an ocean drum (a drum with a double skin on which small metal balls roll imitating the sound of the waves) and a Samafon (an instrument consisting of aluminum tubes of different sizes that are struck with a soft mallet producing long-lasting single or combined tones). The music will consist of improvised music at a slow to moderate tempo, using free-flowing melodies, and simple chord progressions, focusing on creating moments of tension and resolution. The music therapist will also use his/her voice, but without any lyrics or words. After approximately 20 minutes, the music therapist will gradually decrease the volume until the music stops. Receives: Other: Environmental Music Therapy |
| Pre-recorded music | Experimental | The protocol for pre-recorded music is the same as for EMT, but instead of using live improvised music, a recording will be used that will consist of the same musical features and musical instruments as the live music. The recording will be made by the same music therapists who will perform the EMT intervention. Receives: Other: Pre-recorded music |
| Standard care only | Placebo comparator | The control group will receive standard care in the emergency room waiting room as provided by each hospital, but without being exposed to EMT or pre-recorded music. Receives: Other: Standard care only |
What is being measured
The primary outcome is the main question the study is designed to answer.
State-anxiety
It will be measured with the Spanish version of the state scale of the six-item State-Trait Anxiety Inventory (STAI-6) scored on a Likert scale from 1 "absence of anxiety" to 4 "high anxiety".
Measured: The intervention will have a duration of twenty minutes. The STAI-6 will be administered prior to the intervention and immediately following its conclusion.
Secondary outcomes (3)
Stress
Stress levels will be measured by the Visual Analogue Stress Scale (VAS-S). The VAS-S consists of a 10-centimeter line divided into 10 points, each separated by 1 centimeter. 0 means the complete absence of stress and 10 the maximum possible stress. A cut-off of 7 points has been established as a significant stress level.
Measured: The intervention will have a duration of twenty minutes. The VAS-S will be administered prior to the intervention and immediately following its conclusion.
Pain (patients only)
Perceived pain levels by patients will be measured with the Visual Analogue Pain Scale (VAS-P) consisting of a line of 10 centimeters divided into 10 points, each separated by 1 centimeter, where 0 means complete absence of pain and 10 the maximum possible pain.
Measured: The intervention will have a duration of twenty minutes. The VAS-P will be administered prior to the intervention and immediately following its conclusion.
Wellbeing
Well-being will be measured by the Well-being Numerical Rating Scales (WB-NRSs) consisting of a line divided into numbers from 1 to 10, where 1 indicates a state of absolute distress, and 10 a state of absolute well-being.
Measured: The intervention will have a duration of twenty minutes. The WB-NRS will be administered prior to the intervention and immediately following its conclusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start31 Jul 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 243 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claudia Aristizábal
- Sponsor type
- University, hospital or other
- Collaborators
- Sanitas University
- Responsible party
- Sponsor-investigator, Claudia Aristizábal, Sanitas University
- Investigators
- Mark Ettenberger, PhD, Principal investigator, keralty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510153
- Sponsor's protocol ID
- 046-24 UNV
- Status last verified
- Sep 2024
- First submitted
- 8 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: When the study ends, individual participant data could be shared with the approval of the research ethics committee.
Publications
Hernandez A, Diaz AM, Moreno OF, Suarez R, Amarillo M, Moreno AM, Rios Suarez BA, Gomez Gonzalez LM, Cristancho Olaya GA, Ettenberger M. Effect of Live Environmental Music Therapy and Prerecorded Music on State Anxiety, Stress, Pain, and Well-Being Levels of Patients and Caregivers in the Emergency Department Waiting Room: Protocol for a Multicenter Randomized Clinical Trial. JMIR Res Protoc. 2025 Jun 18;14:e69131. doi: 10.2196/69131.
PubMed 40531567
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Live Environmental Music Therapy and Pre-recorded Music on State-Anxiety, Stress, Pain, and Wellbeing Levels of Patients and Caregivers in the Emergency Unit Waiting Area: A Multi-Center Randomized Clinical Trial Study Protocol
- ClinicalTrials.gov ID
- NCT06510153
- Acronym / sponsor ID
- 046-24 UNV
- Conditions
- Anxiety, Stress, Well-Being, Psychological
- Keywords
- Music Therapy, Recorded Music, Anxiety, Stress, Wellbeing, Emergency Care, Waiting Room
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 243 participants (estimated)
- Lead sponsor
- Claudia AristizábalUniversity, hospital or other
- Collaborators
- Sanitas University
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 19 Jul 2024 (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.
Patients and caregivers attending emergency units often experience elevated levels of stress and anxiety. Music has been used in waiting rooms to reduce stress and anxiety, but existing studies on music in emergency unit waiting areas are scarce and have limitations such as low statistical power and limited music selection. The aim of this study is to determine the effect of live Environmental Music Therapy (EMT) and pre-recorded music on state-anxiety, stress, pain and well-being levels in patients and caregivers in the emergency unit waiting areas of two hospitals in Colombia.
This study is a multi-center randomized clinical trial, with three arms: standard care + live EMT, standard care + pre-recorded music, and standard care only. The primary outcome measure is the six-item State-Trait Anxiety Inventory (STAI-6). Secondary outcome measures are pain and stress levels, both measured with a Visual Analogue Scales (VAS), and well-being, measured with the Well-Being Numerical Rating Scales (WB-NRSs). The scales will be applied before and after each intervention.
This study seeks to contribute to improving mental health, wellbeing, and quality of care of patients and caregivers in the waiting area of the emergency units. This is the first study in Colombia investigating the effect live music therapy and pre-recorded music interventions in the emergency department.
Detailed description
Main objective:
To determine the effect of standard care+ EMT or pre-recorded music on the state-anxiety, stress, pain, and wellbeing levels of anxiety-state, stress, pain, and well-being in adult patients and in the emergency waiting rooms of the Clínica Keralty Ibagué and Clínica Iberoamérica as compared to standard care alone.
Secondary objectives:
- Compare the sociodemographic and clinical characteristics of study participants according to the assigned intervention group.
- Evaluate the effect of EMT and pre-recorded music compared to the control group on state anxiety, stress, and wellbeing levels in adult patients and caregivers/companions in the emergency waiting rooms.
- Evaluate the effect of EMT and pre-recorded music compared to the control group on pain levels in patients in the emergency waiting rooms.
- Determine the variables that modify the effect of the interventions on primary and secondary outcomes in adult patients and their caregivers/companions in the emergency waiting rooms.
Methods Study Design
This study is a ramdomized clinical trial, multi-center, and pragmatic with three parallel arms - open label:
- Intervention Group 1 (GI1): Standard care + EMT
- Intervention Group 2 (GI2): Standard care + pre-recorded music
- Control Group (CG): Standard care alone
Study participants Study participants are adult patients and caregivers/companions in the emergency waiting room of both hospitals.
Concealment The concealment of the random assignment will be guaranteed using sealed, sequentially numbered, and opaque envelopes. The carbon paper inside the envelope will transfer the details of the random number and the group to which it is assigned (A, B or C). The envelopes will be sealed with tamper-proof security tape and opened sequentially on each day of intervention. The envelopes will be kept in a folder that will be kept on a locked shelf inside each clinic, which will be in custody by the research assistant at each participating clinic. The envelope will be opened 10 minutes before the start of the intervention to give the music therapists time to organize their equipment and instruments.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Environmental Music Therapy | Experimental | Other: Environmental Music TherapyEnvironmental Music Therapy (EMT) is a music therapy technique that uses live music to modulate the potentially stressful effects of the environment towards an atmosphere that provides a sense of comfort and security. The instruments used will be an acoustic guitar (Yamaha C-40), an ocean drum (a drum with a double skin on which small metal balls roll imitating the sound of the waves) and a Samafon (an instrument consisting of aluminum tubes of different sizes that are struck with a soft mallet producing long-lasting single or combined tones). The music will consist of improvised music at a slow to moderate tempo, using free-flowing melodies, and simple chord progressions, focusing on creating moments of tension and resolution. The music therapist will also use his/her voice, but without any lyrics or words. After approximately 20 minutes, the music therapist will gradually decrease the volume until the music stops. |
| Pre-recorded music | Experimental | Other: Pre-recorded musicThe protocol for pre-recorded music is the same as for EMT, but instead of using live improvised music, a recording will be used that will consist of the same musical features and musical instruments as the live music. The recording will be made by the same music therapists who will perform the EMT intervention. |
| Standard care only | Placebo comparator | Other: Standard care onlyThe control group will receive standard care in the emergency room waiting room as provided by each hospital, but without being exposed to EMT or pre-recorded music. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients and caregivers/companions of legal age present in the emergency waiting room present during the intervention and control conditions.
- Patients whose triage does not represent immediate threat to life or severely ill patients (i.e., triage 3, 4 and 5)
- Patients and caregivers/companions with literacy skills.
Key exclusion criteria (3 listed)
- Patients and caregivers/companions who report having hearing problems
- Patients and caregivers/companions with difficulties in understanding and/or filling out the questionnaires.
- Patients and/or caregivers/companions who do not consent to participate in the study.
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 |
|---|---|---|
| Environmental Music TherapyThe music will consist of improvised music at a slow to moderate tempo, using free-flowing melodies, and simple chord progressions, focusing on creating moments of tension and resolution during approximately 20 minutes. | Other | Environmental Music Therapy |
| Pre-recorded musicThe protocol for pre-recorded music is the same as for EMT. | Other | Pre-recorded music |
| Standard care onlyStandard care in the emergency room waiting room as provided by each hospital without being exposed to EMT or pre-recorded music. | Other | Standard care only |
Primary outcome
State-anxiety
Time frame: The intervention will have a duration of twenty minutes. The STAI-6 will be administered prior to the intervention and immediately following its conclusion.
It will be measured with the Spanish version of the state scale of the six-item State-Trait Anxiety Inventory (STAI-6) scored on a Likert scale from 1 "absence of anxiety" to 4 "high anxiety".
3 secondary outcomes
Stress
Time frame: The intervention will have a duration of twenty minutes. The VAS-S will be administered prior to the intervention and immediately following its conclusion.
Pain (patients only)
Time frame: The intervention will have a duration of twenty minutes. The VAS-P will be administered prior to the intervention and immediately following its conclusion.
Wellbeing
Time frame: The intervention will have a duration of twenty minutes. The WB-NRS will be administered prior to the intervention and immediately following its conclusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 40531567Hernandez A, Diaz AM, Moreno OF, Suarez R, Amarillo M, Moreno AM, Rios Suarez BA, Gomez Gonzalez LM, Cristancho Olaya GA, Ettenberger M. Effect of Live Environmental Music Therapy and Prerecorded Music on State Anxiety, Stress, Pain, and Well-Being Levels of Patients and Caregivers in the Emergency Department Waiting Room: Protocol for a Multicenter Randomized Clinical Trial. JMIR Res Protoc. 2025 Jun 18;14:e69131. doi: 10.2196/69131.
- Individual participant dataSharing planned: No. When the study ends, individual participant data could be shared with the approval of the research ethics committee.
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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. This study is not recruiting at the moment.
Mark Ettenberger, PhD principal investigator
keralty
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Environmental Music Therapy and Pre-recorded music in people with Anxiety and Stress, run by Claudia Aristizábal at 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark Ettenberger, PhD (+57 311 2847635, mark.ettenberger@gmx.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State-anxiety (time frame: The intervention will have a duration of twenty minutes. The STAI-6 will be administered prior to the intervention and immediately following its conclusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06510153, which also lists 1 linked publication.
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 19 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.