Ignite Creation Date:
2024-10-25 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510153
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Music Therapy and Pre-recorded Music on Patients and Caregivers in the Emergency Unit
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 caregiverscompanions 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 caregiverscompanions 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 caregiverscompanions 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
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 caregiverscompanions 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 caregiverscompanions 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 caregiverscompanions 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None