Evaluation of Culture-specific Popular Music as a Mental Metronome for Cardiopulmonary Resuscitation (COMSCPR)
Primary Purpose
Cardiac Arrest, Out-of-hospital Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Count on me Singapore (COMS) CPR
Standard CPR
Sponsored by
About this trial
This is an interventional health services research trial for Cardiac Arrest
Eligibility Criteria
Inclusion Criteria:
- All volunteers are eligible. This mimics a real world situation where any trained member of the public can provide bystander CPR.
Exclusion Criteria:
- Lack of informed consent
- Existing medical conditions that may cause danger to the participant (e.g. cardiac conditions or musculoskeletal injuries)
- Recent CPR course attended (within past one month)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
COMSCPR first
Standard CPR first
Arm Description
Group A will proceed to perform one cycle (two minutes) of COMSCPR. After taking a fifteen minute rest, participants will cross over to perform one cycle of the other method of CPR.
Group A will proceed to perform one cycle (two minutes) of Standard CPR. After taking a fifteen minute rest, participants will cross over to perform one cycle of the other method of CPR.
Outcomes
Primary Outcome Measures
Average compression rate
As read by Laerdal SkillReporter
Secondary Outcome Measures
Average depth of compression
As read by Laerdal SkillReporter
Number of incorrect hand placement alerts
As read by Laerdal SkillReporter
Number of compressions with inadequate recoil
As read by Laerdal SkillReporter
Fatigue level after a cycle of CPR of 2 minutes duration, on a 10-point scale
Survey on a 10-point scale
Satisfaction of CPR provider in terms of ease of learning, fatigue and overall effectiveness assessed with a Survey on a 5-point scale
Survey on a 5-point scale
Ability to retain compression rate using COMS CPR after a 7-14 day interval with no additional prompting in between
As read by Laerdal SkillReporter
Full Information
NCT ID
NCT02940964
First Posted
October 17, 2016
Last Updated
February 12, 2017
Sponsor
Singapore General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02940964
Brief Title
Evaluation of Culture-specific Popular Music as a Mental Metronome for Cardiopulmonary Resuscitation
Acronym
COMSCPR
Official Title
Evaluation of Culture-specific Popular Music as a Mental Metronome for Cardiopulmonary Resuscitation: A Randomized Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 17, 2016 (Actual)
Primary Completion Date
October 20, 2016 (Actual)
Study Completion Date
November 23, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Abstract
Introduction
Bystander cardiopulmonary resuscitation (CPR) can more than double the patient's chance of survival in Out-of-hospital cardiac arrest (OHCA). In Singapore, bystander CPR rate was low. Recent studies have proposed and validated the use of popular songs as aids in performing CPR. These songs may not be widely known when applied to a different population, and further, may lose popularity over time. "Count on me Singapore" (COMS) is believed to be known to over 90% of the Singapore population. Pilot data indicated that CPR performed using COMS as a mental metronome (COMSCPR) can achieve guideline-compliant rate of chest compression with lower fatigue level than CPR guided by the conventional "one-and-two-three-and" (Standard CPR). The investigators hypothesize that COMSCPR is non-inferior to Standard CPR in achieving guideline-compliant rate of chest compression.
Methodology
The investigators planned a prospective, randomized, crossover non-inferiority trial comparing COMS CPR and Standard CPR. 80 eligible volunteers will be recruited from a convenience sample of camp personnel from a military training camp. After a 15 minutes familiarization session, they will be randomized into two groups (A and B). Group A will proceed to perform one cycle (two minutes) of Standard CPR, while group B will proceed to perform one cycle of COMS CPR. participants will cross over to perform one cycle of the other method of CPR. After completing this second cycle, a survey form will be administered. The Laerdal SkillReporter will be used to measure the CPR performed. After a 7-14 days interval, participants will be recalled to attend a test scenario. Statistical analysis will be used to compare the two arms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest, Out-of-hospital Cardiac Arrest
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COMSCPR first
Arm Type
Experimental
Arm Description
Group A will proceed to perform one cycle (two minutes) of COMSCPR. After taking a fifteen minute rest, participants will cross over to perform one cycle of the other method of CPR.
Arm Title
Standard CPR first
Arm Type
Active Comparator
Arm Description
Group A will proceed to perform one cycle (two minutes) of Standard CPR. After taking a fifteen minute rest, participants will cross over to perform one cycle of the other method of CPR.
Intervention Type
Behavioral
Intervention Name(s)
Count on me Singapore (COMS) CPR
Other Intervention Name(s)
COMSCPR
Intervention Description
Using the song as a mental metronome to guide CPR.
Intervention Type
Behavioral
Intervention Name(s)
Standard CPR
Intervention Description
Standard CPR with "one-and-two-and-three...." counting
Primary Outcome Measure Information:
Title
Average compression rate
Description
As read by Laerdal SkillReporter
Time Frame
Immediately after 2 min of CPR
Secondary Outcome Measure Information:
Title
Average depth of compression
Description
As read by Laerdal SkillReporter
Time Frame
Immediately after 2 min of CPR
Title
Number of incorrect hand placement alerts
Description
As read by Laerdal SkillReporter
Time Frame
Immediately after 2 min of CPR
Title
Number of compressions with inadequate recoil
Description
As read by Laerdal SkillReporter
Time Frame
Immediately after 2 min of CPR
Title
Fatigue level after a cycle of CPR of 2 minutes duration, on a 10-point scale
Description
Survey on a 10-point scale
Time Frame
Immediately after completing both types of CPR (crossover) 2 minutes
Title
Satisfaction of CPR provider in terms of ease of learning, fatigue and overall effectiveness assessed with a Survey on a 5-point scale
Description
Survey on a 5-point scale
Time Frame
Immediately after completing both types of CPR (crossover) 2 minutes
Title
Ability to retain compression rate using COMS CPR after a 7-14 day interval with no additional prompting in between
Description
As read by Laerdal SkillReporter
Time Frame
Between 7-14 days
10. Eligibility
Sex
All
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All volunteers are eligible. This mimics a real world situation where any trained member of the public can provide bystander CPR.
Exclusion Criteria:
Lack of informed consent
Existing medical conditions that may cause danger to the participant (e.g. cardiac conditions or musculoskeletal injuries)
Recent CPR course attended (within past one month)
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evaluation of Culture-specific Popular Music as a Mental Metronome for Cardiopulmonary Resuscitation
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