Music Therapy and Pre-recorded Music on Patients and Caregivers in the Emergency Unit

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

Overview

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.

Interventions

• Other Environmental Music Therapy
  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.
• Other Pre-recorded music
  The protocol for pre-recorded music is the same as for EMT.
• Other Standard care only
  Standard care in the emergency room waiting room as provided by each hospital without being exposed to EMT or pre-recorded music.

Primary outcome measures

• 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.]

Secondary outcome measures (3)

• 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Colombia · 2 centers

• Clínica Iberoamérica — Barranquilla
• Clínica Keralty Ibagué — Ibague

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 PMID 40531567

Identifiers

NCT: NCT06510153 · 046-24 UNV

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗