Music Therapy and Pre-recorded Music on Patients and Caregivers in the Emergency Unit
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClaudia Aristizábal
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Environmental Music Therapy
Other interventionThe 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 music
Other interventionThe protocol for pre-recorded music is the same as for EMT.
Standard care only
Other interventionStandard care in the emergency room waiting room as provided by each hospital without being exposed to EMT or pre-recorded music.
Treatment groups
243 Participants
are divided into 3 treatment groupsGroup A: Environmental Music TherapyExperimental treatment 1 intervention
Group B: Pre-recorded musicExperimental treatment 1 intervention
Group C: Standard care onlyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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".
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 outcomes
1
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.
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.2
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.
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.3
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.
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov