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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
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cardiac Arrest

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    October 17, 2016
    Last Updated
    February 12, 2017
    Sponsor
    Singapore General Hospital
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    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

    Learn more about this trial

    Evaluation of Culture-specific Popular Music as a Mental Metronome for Cardiopulmonary Resuscitation

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