Evaluation of Culture-specific Popular Music as a Mental... | NCT02940964

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

NCT02940964

Sponsor

Singapore General Hospital

Status

Completed

Last Update Posted

Feb 14, 2017Actual

Enrollment

90Actual

Phase

Not Applicable

Conditions

Cardiac Arrest
Out-of-hospital Cardiac Arrest

Interventions

Count on me Singapore (COMS) CPR
Standard CPR

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2016Actual

Primary Completion Date

Oct 20, 2016Actual

Completion Date

Nov 23, 2016Actual

First Submitted Date

Oct 17, 2016

First Submission Date that Met QC Criteria

Oct 20, 2016

First Posted Date

Oct 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 12, 2017

Last Update Posted Date

Feb 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
COMSCPR first	Experimental	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.	Behavioral: Count on me Singapore (COMS) CPR
Standard CPR first	Active Comparator	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.	Behavioral: Standard CPR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Count on me Singapore (COMS) CPR	Behavioral	Using the song as a mental metronome to guide CPR.	COMSCPR first

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Average compression rate	As read by Laerdal SkillReporter	Immediately after 2 min of CPR

Secondary Outcomes

Measure	Description	Time Frame
Average depth of compression	As read by Laerdal SkillReporter	Immediately after 2 min of CPR
Number of incorrect hand placement alerts	As read by Laerdal SkillReporter

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest
D058687	Out-of-Hospital Cardiac Arrest

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016887	Cardiopulmonary Resuscitation

Ancestor Terms

ID	Term
D012151	Resuscitation
D004638	Emergency Treatment
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided