Clinical trial NCT06510153: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety
Stress
Well-Being, Psychological
Keywords: Music Therapy
Recorded Music
Anxiety
Stress
Wellbeing
Emergency Care
Waiting Room
Lead sponsor: Sanitas University
Sponsor class: OTHER
Collaborators: name: Sanitas University
First posted: 2024-07-19
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

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.

Primary outcomes:
measure: State-anxiety
timeFrame: 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:
measure: Stress
timeFrame: The intervention will have a duration of twenty minutes. The VAS-S will be administered prior to the intervention and immediately following its conclusion.
measure: Pain (patients only)
timeFrame: The intervention will have a duration of twenty minutes. The VAS-P will be administered prior to the intervention and immediately following its conclusion.
measure: Wellbeing
timeFrame: The intervention will have a duration of twenty minutes. The WB-NRS will be administered prior to the intervention and immediately following its conclusion.
Other outcomes:
Locations:
city: Barranquilla
country: Colombia
facility: Clínica Iberoamérica
state: Atlántico
city: Ibagué
country: Colombia
facility: Clínica Keralty Ibagué
state: Tolima
Study officials:
affiliation: keralty
name: Mark Ettenberger, PhD
role: PRINCIPAL_INVESTIGATOR
References: