NCT06510153 Music Therapy and Pre-recorded Music on Patients and Caregivers in the Emergency Unit
| NCT ID | NCT06510153 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Claudia Aristizábal |
| Condition | Anxiety |
| Study Type | INTERVENTIONAL |
| Enrollment | 243 participants |
| Start Date | 2024-07-31 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 243 participants in total. It began in 2024-07-31 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Mark Ettenberger, PhD
PRINCIPAL INVESTIGATOR
keralty
Frequently Asked Questions
Who can join the NCT06510153 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anxiety. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06510153 currently recruiting?
Yes, NCT06510153 is actively recruiting participants. Contact the research team at mark.ettenberger@gmx.at for enrollment information.
Where is the NCT06510153 trial being conducted?
This trial is being conducted at Barranquilla, Colombia, Ibague, Colombia.
Who is sponsoring the NCT06510153 clinical trial?
NCT06510153 is sponsored by Claudia Aristizábal. The principal investigator is Mark Ettenberger, PhD at keralty. The trial plans to enroll 243 participants.
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