NCT Number: NCT06510153
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Clínica Iberoamérica, Barranquilla, Atlántico, Colombia
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:
Methods Study Design
This study is a ramdomized clinical trial, multi-center, and pragmatic with three parallel arms - open label:
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The protocol for pre-recorded music is the same as for EMT.
Standard care in the emergency room waiting room as provided by each hospital without being exposed to EMT or pre-recorded music.
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".
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.
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-P will be administered prior to the intervention and immediately following its conclusion.
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 WB-NRS will be administered prior to the intervention and immediately following its conclusion.
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.
Contact information is provided by the study sponsor or research team.
Claudia Aristizábal
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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